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Novartis International AG (NYSE:NVS)
Q3 2019 Earnings Call
Oct. 22, 2019, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning and good afternoon. And welcome to the Novartis Q3 2019 Results Release Conference Call and Live Audio Webcast. (Operator Instructions)With that, I would like to hand over to Mr. Samir Shah, Global Head of Investor Relations. Please go ahead, sir.

Samir ShahGlobal Head of Investor Relations

Thank you very much, and good morning, and good afternoon, everybody. Thank you so much for taking the time to join us for the investor call.

Before we start, I’ll just read you the Safe Harbor statement. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties and other factors. These may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Please refer to the Company’s Form 20-F on file with the US Securities and Exchange Commission for a description of some of these factors.

With that, I’ll hand across to Vas.

Vasant NarasimhanChief Executive Officer

Thank you, Samir, and thanks, everyone, for joining today’s conference call. As you saw earlier today, we announced what I think are really excellent results demonstrating the strong operational performance happening at Novartis, our continued progress on our innovation, as well as continuing to drive our strategic priorities, which we believe will drive sustainable long-term top and bottom line growth.

When you go to slide — the first slide, Slide 4, just to give a little more color on what you all saw earlier today. We had double-digit top and bottom line growth in the quarter. Sales were up 13%, core operating income up 18% and core margin up 1.4%. Harry will go through these numbers in more detail, along with describing in a bit more detail as well our guidance increase, where we increased both sales and core operating income guidance for the year.

Equally as important, we had strong innovation performance in the quarter. When you look at it, we’re on — we are right on track to potentially have four — potentially five new molecular entities approved in the United States, which really shows the kind of innovation power we have in the Company. Beovu was launched in the US, ofatumumab, of course, compelling efficacy in RMS, and then a number of other key milestones, many of which we’ll go through over the course of this call.

So turning to the next slide. One of the important trends we want to start highlighting is how our key growth drivers are increasingly contributing to our overall sales performance. When you look at Innovative Medicine sales nine months to-date in 2019, we’ve grown now to have 28% of our sales coming from our key growth drivers, and many of these key growth drivers have very strong underlying dynamics as we’ll talk about on the next slide.

In addition, our growth contribution is primarily coming from these growth drivers. We do have some, of course, Gx erosion and — but — and then some other benefits. But overall, the primary contributor to our growth year-to-date has been these key growth drivers, most of which are recent launches.

Now, if you go to Slide 6, you can see in a bit more detail we had broad-based strong growth across our growth drivers, across the portfolio, whether that was in Pharmaceuticals with Cosentyx, Entresto, Xiidra, Zolgensma in our cell and gene therapies efforts, and in oncology, overall, so you see broad-based growth. So I think when you look at it overall, we’re firing really on all cylinders as a company in terms of driving our in-line brands and launched brands.

Now, if you go to the next slide, Slide 7, diving in deeper into the individual products. Let’s start with Cosentyx. And in Cosentyx, we once again had a very strong quarter with 27% overall sales growth, driven by both strong ex-US and US performance. Now, first start talking a bit about dermatology. There, we see the market growing at 17% from a TRx standpoint and Cosentyx continuing to grow ahead of the market at 32%, despite intensifying competition. So we believe we’re well placed. We also believe we will be well placed next year to maintain our first line positioning and we’ll be happy to answer more questions about that in the Q&A.

And then when you look in rheumatology, we also are continuing to have the strong growth based on our strong underlying data where we grew at 36% versus a market that’s growing at 15%. We had some positive news as well with an additional CHMP opinion on the higher dose, as well as the PREVENT trial meeting primary endpoints at 16 weeks and 52 weeks.

To go into a little bit more detail on the next slide on where a Cosentyx is building further positions in the market. Our non-radiographic axial SpA data clearly shows the potential of Cosentyx to move into a broader range of patients with ankylosing spondylitis. When you look at the left-hand side of the chart, you can see there are 3.2 million patients with psoriatic arthritis, 1.7 million patients with ankylosing spondylitis and then an equal number of patients with non-radiographic ankylosing axial spondyloarthritis. When you look at the biologics penetration in this kind of early SpA group, there is biologics penetration of only 4% to 8%. So this is an exciting opportunity for us now to take forward around the world.

We’re also well-positioned beyond just the current rheumatology indications. When you look at some of the data readouts we have, but importantly additional clinical trials we have in hidradenitis suppurativa, pediatric indications, as well as additional new study starting in rheumatology, including giant cell arthritis, we feel very confident in Cosentyx’s longer-term trajectory and we look forward to our R&D Day to give you more color on some of those additional indication programs.

Now moving to the next slide with Entresto. With Entresto, we continue to see strong underlying dynamics. Entresto revenues were up 61% with growth — strong growth, both in the ex-US and US. When you look at weekly TRxs, we are up 51%, Q3 2018 to Q3 2019. And as you can see from the slope of the line, we just have this continued solid, steady uptake in TRx in the US, and we see a similar trend in other key markets around the world. Now, both PROVE and EVALUATE at HF provided additional mechanistic support for Entresto and we see that increasingly influencing guideline bodies around the world. FDA also approved a pediatric indication for Entresto in Q4.

Now moving to the next slide. When you look at the PARAGON-HF study which we readout in Q3, and I think, many of you already know these results as described at ESC, the preserved ejection fraction heart failure population is the population that currently is completely unserved, and these patients are looking for some treatment option. We narrowly missed the primary endpoint on the overall population, but we had important subgroups, including at the subgroup of patients with an ejection fraction up to 57%, as well as patient — as well as female patients in the study who had significant benefits.

So after discussions with the US FDA we now planned to move forward with a regulatory submission for inclusion of data into the label in Q4 2019. We’re continuing to engage in discussions with Europe — EU and other regulators to discuss how best to take forward this data. But we are determined to try to find a way to reflect the benefits of Entresto in a broader patient population in an appropriate way.

Now, if you go to Slide 11. Zolgensma off to a strong start, as you saw, year-to-date, with sales of $175 million since launch. A few comments on access. I’m very proud of our access efforts within our team in the US. They’ve done an outstanding job, getting now access with 90% of commercial patients and 30% of Medicaid patients with a policy in place. Importantly, we are now still seeing 99% final approval rates for patients that are on label after we go through the appropriate appeals processes.

We’re seeing a solid demand in a broad base of institutions. Over 50 treating institutions now in the US, including many leading academic centers of excellence have prescribed now Zolgensma. And when you look at the patient profile, we’re seeing patients across SMA types, the incident and prevalent populations, as well as 50% patients coming from switches from the approved — currently licensed product nusinersen.

So if you go to Slide 12, looking forward for Zolgensma. I think, a general comment I’d say is, you can expect, given that in Q3 we worked up through some of the pent-up demand for the product, much of which we had also addressed through our managed access program, but there was some pent-up demand still we were working through in Q3, we expect Q4 to be broadly in line with Q3 for Zolgensma. But then moving forward, we see opportunities both in the US and outside the United States.

First in the US, we expect this newborn screening climbs from 30% of newborns to 70% of newborns or higher by the end of 2020. This will be an important additional growth driver for Zolgensma. We also — we — and we know that two-thirds of incident patients treated in the States with newborn screening are getting Zolgensma. So I think this is an important trend for us.

We also expect Medicaid policies to increasingly come into place over the coming 12 months, including in Florida, New Jersey and Michigan. And many of you saw our interim strong data, which really showed, I think, the strong profile of Zolgensma in SMA Type II patients, with impressive scores on the HFMSE scoring for patients two years to five years of age.

Right now, from a regulatory standpoint, we are awaiting FDA feedback on BIC filing approach. We have provided FDA with the dataset that we recently presented and are in discussions with FDA on the appropriate approach to filing. For Zolgensma, in the current IV indication, we expect CHMP opinion in Q1 2020. I know there are questions surrounding that. The primary reason for that were an extensive set of questions with respect to the manufacturing in PMC. We have now submitted those responses. But we need to continue to work through these responses with EMA to get to the final positive opinion.

And then in Japan, we expect a decision in first half 2020. We, importantly, have early access programs now in place in France, Portugal and Germany. So, overall, I think, Zolgensma well on track to reach our longer term aspirations.

Now if you move to Slide 13. Beovu is off to a strong start in the US. When you look at the US launch at AAO with a highly competitive label. We’re very excited about this medicine. We see it as a medicine that provides benefits both with the possibility for patients to have fewer intravitreal injections, but also important data with respect to visual and anatomical measures of the disease. You have longer treatment intervals achievable without compromising efficacy. That’s a key differentiator for this medicine.

We have supportive label language on visual and anatomical measures which will enable us to discuss the important data we have both with respect to retinal fluid and central retinal subfield thickness, and we have an overall safety profile in line with comparator products on the market. So taken together, we think this is a very compelling case. We can say that at least the early signs are very positive on how the launch is already going. So we look forward to keeping you up-to-date on how the Beovu US launch progresses.

Now if you go to the next slide, we also have a broad comprehensive clinical trial program ongoing to look both at potential new indications, as well as to better profile Beovu in the core AMD indication. A few things to highlight here, and of course, we are happy to provide more details in the R&D Day on this overall program. But when you look at the TALON study, it’s a head-to-head superiority study of Beovu versus aflibercept evaluating treatment interval duration in an identical treat to control regimen. I think this is a study which shows our confidence in the overall profile of the medicine.

We have the MERLIN study, which is a head-to-head non-inferiority study to cover the q4week population, which we believe will be a small portion of patients that would need q4 dosing but nonetheless one patient population we want to address. We also have a head-to-head superiority study ongoing in PCV, which is another opportunity for us to continue to differentiate the medicine. I think the key message here is, we have confidence in Beovu — confidence in the potential of this medicine to be a significant advance for patients with these diseases.

Now if you move to Slide 15. Ofatumumab also readout in the quarter with, I think, really extraordinary data. When you look at it, it now can be a high efficacy disease modifying therapy. But our goal will be to position it, being able to be used early and broadly. We think of this as not a medicine we’re focused on competing within the B-cell space. We want patients with RMS to have access to B-cell therapies as early as possible in their disease progression.

When you looked at the data, you saw strong efficacy results versus teriflunomide across a range of different endpoints. I think all of you have seen that data. Also a highly competitive overall profile, high efficacy, favorable safety profile, continue — convenient subcutaneous injection with an auto injector and no need for an infusion center. And our plan is to initiate worldwide regulatory submission starting in Q4 2019.

One thing I wanted to clarify that may have been misunderstood from our press release, our US filing is a filing, it’s not a rolling submission. We only meant to imply that we will be rolling out our submissions around the world over the course of the coming months. But our US filing is a straight filing, complete filing that will happen in Q4 of this year.

So moving to Slide 16. Now look — turning to Mayzent. So with — Mayzent, I think, as many of you have seen, very strong market feedback, very strong interest from physicians and patients. It has a unique label with unique data, the only medicine ever to be studied successfully in secondary progressive — active secondary progressive MS, with very strong data that we continue to roll out, including recent data on cognitive processing speed, as well as a four-year delay to the need to use a wheelchair. We are seeing a strong interest in the medicine. 90% willingness to prescribe over 2,600 request forms now and 150 million lives with preferred and unrestricted access.

Our key goal now is to enable a more rapid onboarding of these patients. We’re seeing right now about a 90-day lag between initial interest in the medicine and actually getting patients fully on board with paid Rxs. We expect to work hard to shorten that timeline, as well as to work through the backlog of patients, driving urgency to treat, simplify the onboarding, and we hope then to be able to demonstrate further sales progress in the coming quarter. But overall, we think we’re in a solid place with respect to how the medicine is being perceived with the foundations now put into place. We expect CHMP positive opinion in late Q4 2019.

Now moving to Slide 17, now fevipiprant. Fevipiprant, today we announced the results of the ZEAL 1 and 2 study. But it’s important to note where ZEAL 1 and 2 fit into the overall program. Our core goal with fevipiprant was to study the medicine in severe asthma with a focus on high eosinophil severe asthma, as other biologics have studied. That is the core — a group of the LUSTER 1 and 2 programs, with a further potential to look at patients who are low eosinophils in that study. That is the core of the overall fevipiprant study program.

We also were asked to study, as is often the case with these programs, to study the medicine in less severe patients using an FEV1 endpoint, and that was the ZEAL 1 and 2 programs in so-called GINA 3/4 patients, so kind of moderate severity asthma patients. And there we saw no significant improvements in FEV1 on top of the standard ICS+LABA regimen. But we saw a very clean safety profile. It’s important to note we only took the 150-milligram dose into this population, and we did not stratify for eosinophils as well. So right now we are continuing to work through the completion of the LUSTER program and look forward to reading out that program in full in Q1 2020.

Now moving to the next slide. Now switching gears to Oncology. While Oncology had a broad-based outstanding performance with double-digit sales growth, I wanted to highlight that the outstanding performance we had in terms of one of our launches, Piqray. So Piqray was launched as the first and only therapy for advanced breast care patient — breast cancer patients with PIK3CA mutation.

When you look at the sales growth here, you can see a really strong uptake. 40% of patients with hormone receptor-positive HER2-negative advanced breast cancer have a PIK3CA mutation. So really our goal here was to ensure a broad-based uptake of the testing. And I think our teams in the US have done an outstanding job, enable that — enabling that testing to be broadly available.

We now expect CHMP positive opinion in the first half of — CHMP opinion in the first half of 2020, and our focus is to take Piqray into additional indications, including programs in HER2 positive breast cancer, triple-negative breast cancer, head and neck cancers and ovarian cancers. So you will see us continuing to work to expand the utilization of Piqray and we believe this medicine can be a blockbuster over time.

Now moving to Slide 19. We also released additional data on Kisqali, demonstrating the overall survival benefit of this medicine as the only CDK4/6 inhibitor to demonstrate overall survival in two Phase III trials. One important element to remember about Kisqali is we believe it is unique in its profile and its ability to agonize the CDK4 part of this pathway. And with that unique profile, we think that really enables us to have a mechanistic differentiation for Kisqali.

Now, our goal right now is to continue to educate the physician community about the MONALEESA-3 and MONALEESA-7 data, particularly the 28% and 29% reductions in the risk of death, and we’ll look forward to further differentiating Kisqali with additional readouts, including the MONALEESA-2 overall survival data, which we will readout next year.

Now moving to Slide 20. If you look at our overall 2019 expected milestones. I think we had a great innovation performance year-to-date and we hope to carry that forward with a strong finish to the year. You can see that we’ve reached nearly all of our milestones. A few milestones were pushed into the first part of next year, but overall, I think, a very strong performance.

And when you go to Slide 21, I wanted to just highlight a few of the catalysts. We expect a number of key approvals next year, importantly, ofatumumab and Cosentyx in non-radiographic axial SpA, but also SEG101 in sickle cell disease. A range of key submissions, we’ve already talked about AVXS and fevipiprant. But we also will have the readout an hopeful submission of the data are positive of Lu-PSMA, one of our ligand therapies for prostate cancer, as well as the submission of our triplet combo with PDR001 and Mekinist and Tafinlar.

And lastly, a range of key readouts. We’re excited to tell you more about our — depth of our portfolio in our R&D Day in early December. But a few to highlight, ABL001 and CML, which we also now are planning to use in other lines of therapy. We also will have readouts in Beovu in DME; a range of Phase II readouts. I’ll note LNP023, which is our factor B inhibitor. We’ll have data presented at ASH, and I think, can eventually be a cornerstone therapy for PNH and renal diseases. So a range of things going on and we’ll provide more depth on those milestones in early December.

So, with that, I’ll hand it over to Harry.

Harry KirschChief Financial Officer

Yes, thank you, Vas. Good morning, good afternoon, everyone. As always, my comments refer to the results of the continuing operations and growth rates in constant currencies unless I note otherwise.

So on Slide 23, you see the summary of our quarter three and first nine months continuing operation performance. As Vas said, our quarter three performance was excellent, with double-digit sales growth, driving core operating income and strong cash flow of $4 billion. Sales grew 13%, mainly driven by the continued momentum of key growth drivers as Vas laid out. We also benefited from the first full quarter of the strong launch of Zolgensma and Piqray, as well as the acquisition of Xiidra. Core operating income grew 18%, mainly driven by sales and also productivity program impacts. You’ll see a similar pattern on year-to-date results. Year-to-date sales growth of 9% drove core operating income growth of 18% and resulting free cash flow of $9.4 billion in the first nine months.

On Slide 24, we have laid out the first nine months and quarter three core margin by division. Continuing operations margin improved by 1.4 percentage points (Phonetic) in the quarter and 2.4 percentage points (Phonetic) year-to-date. In Innovative Medicines, strong quarter three sales growth of 15%, enabled core margin improvement with 34% of sales. Sandoz had a particularly strong quarter with 5% sales growth and 18% core operating income growth, resulting in a core margin of almost 25%. The growth in Sandoz was mainly driven by biopharmaceuticals growing 27%, as well as productivity from the ongoing transformation programs falling through to the bottom line. Additionally, quarter three at Sandoz was hedged by first — three first file retail launches in US and the favorable one-time Medicaid revenue deduction adjustment in the quarter. Overall, year-to-date, you’ll see very strong margin expansions in both divisions, with Sandoz margin of 22% almost and Innovative Medicines margin of 34%.

On the next slide, Slide 25, just to the guidance. So in light of our very strong performance, we are revising upwards our 2019 full-year guidance once more. This is clearly driven by the very good performance of our growth drivers and launches. In addition, we saw less generic impact on our encore mature products than expected in the quarter three, which we discussed this scenario at the quarter two call.

So, for the new focused medicines company, net sales are revised upwards, expected to grow high-single digits and core operating income for the Company revised upwards, expected to grow mid-to-high-teens. From a divisional perspective, we revised Innovative Medicines sales guidance upwards to grow high-single to low double-digit, and Sandoz sales guidance is revised upward to grow low single-digit.

On Slide 26, I want to walk you through some of the dynamics for the fourth quarter versus the nine months. Now, we are having a very strong 2019, with core operating income growth of 18% year-to-date. As you can see, this is mainly driven by excellent sales momentum of our growth drivers and launches, and also the productivity programs we have put in place. But we had also a very moderate generic impact on some of our older Innovative Medicines brands and upside on valsartan from competitors’ supply shortages.

So, as we move into quarter four, we continue to expect our growth drivers and launches to be very successful. We also expect continued benefits from our ongoing productivity programs. However, we also plan to further increase investments in launches and pre-launches such as Beovu, Mayzent, Piqray, Xiidra and ofatumumab. As of quarter three, we do lap the valsartan upside in the base and valsartan generics are starting to return to several markets.

In addition, we expect increased generic competition on Afinitor, Exjade/Jadenu and some mature ophthal brands. However, as always in these cases, we do not know exactly when the generics will enter the market. So, if generic entries would come again later or would continue to have minimal impact on our results in quarter four, we would expect to be at the higher end of the full-year guidance. As you know, the above mentioned mature onco and mature ophthal generic entries are a matter of time and you need to consider that also in your modeling for 2020.

On Slide 27, quickly let’s look at how the currencies would impact our results if mid-October rates would prevail for quarter four and for 2020. So you see the effect of the strength — mainly strengthening dollar to diminish over time in quarter four already, but the full year 2019 would be a negative 3% on sales and a negative 5% FX impact on core operating income. In 2020, the currency impact would diminish down to a minus 1% for both sales and core operating income. And as you know, currencies fluctuate a lot, we update this in our website every month. So you have, hopefully, a very transparent picture on currency impacts on our results on a monthly basis.

And with that, I hand back to Vas.

Vasant NarasimhanChief Executive Officer

Thank you, Harry. So just in summary — just the last slide. We continue to see tremendous momentum overall in the Company. When you look at the sales and operating (Technical Issues) very good about where we are, and I think, we’ll look forward to taking your questions.

So, with that, I will hand it back to Samir.

Samir ShahGlobal Head of Investor Relations

Thank you. Operator, we’ll be open for Q&A. And as we have large — rather a lot of questions today, can I please ask each person who is asking the questions, to limit themselves to only two questions? Thank you.

Questions and Answers:

Operator

Thank you.

Vasant NarasimhanChief Executive Officer

Great. Operator, so we’ll take the first question.

Operator

(Operator Instructions) Our first question comes from the line of Graham Parry from Bank of America. Please ask your question.

Graham ParryBank of America — Analyst

Great. Thanks for taking my questions. So firstly, on Zolgensma, you talked through some of the moving parts and the potential drivers into next year. But I was wondering if you could express any level of comfort with the consensus number of $1.2 billion at the moment, which would seem to assume either very high penetration into the incident patient population or quite a lot of prevalent patients being accessed through the course of the year. So, is there enough prevalent penetration left after your bolus to get you to that number?

And then secondly on Gilenya, it looks like you’ve settled that with Mylan looking at the court dockets and the stay there. Could you give us any kind of feel for what sort of time frame that would be coming into the market and whether you would expect to be seeking similar settlements with the other generic filers given the rather positive comments in the preliminary injunction from the judge? Thank you.

Vasant NarasimhanChief Executive Officer

Thanks, Graham. First, on Zolgensma. As I explained on the dynamics, I think the key drivers here are going to be the continued penetration in the incident population where our goal will be, in the United States, to achieve very high coverage of incident patients, both in newborn screening or those identified later on after newborn screening to continue to drive switches.

And it’s important to note that while we have covered a portion of the prevalent patients to date, because we haven’t reached the highest levels of coverage within the incident population, there will continue to be opportunities for switches for Zolgensma in the — we will expect in the coming year. And that’s a second source of business.

The third will be the global launch, which we hope to achieve in — to enable us to go into Europe and other markets. You’ll, I think, likely note from the competitor sales as well, there are substantial sales opportunities outside the United States. We continue to prepare and develop those markets. I think our ability to launch in Europe, the Middle East, eventually in Latin America and Asia, will provide an important opportunity for Zolgensma IV.

And then lastly, of course, once we clarify the final filing and time lines, we’ll provide further guidance on the intrathecal formulation and when we would expect that launched. So overall, I think a lot of catalysts coming for Zolgensma, a lot of positive momentum and energy around the data, a lot of interest from the physician and patient communities around the world. So we are confident in our longer-term outlook for this medicine.

Now with respect to Gilenya. With respect to the recent court injunction, which now covers all generic manufacturers, I think that’s what you’re referring to, when you look at any potential settlements, we’re not disclosing any details of those settlements. Those discussions, of course, are ongoing. But just to remind everyone, we would expect at some point next year a ruling from the District Court — or the start of a trial with the District Court, which will be important as well as the ruling on the appeal of the IPR ruling. Those are the next milestones with respect to Gilenya. But we feel very confident with our position, given the language used in the initial IPR ruling, the strength of our recent restraining order that was put in place. And so I think overall, we feel good about where we are in this process.

Next question?

Operator

Thank you. Our next question comes from the line of Peter Welford from Jefferies. Please ask your question.

Peter WelfordJefferies — Analyst

Hi, yes. Thanks for taking my questions. Firstly, just with regards to Zolgensma, I guess, following up in terms of the commentary that 4Q will be broadly in line. I guess given that you’ve seen a roughly similar split of incident versus prevalent patients, if I understand right, in the third quarter, and presumably, there’s still quite a large prevalent population of less than two years old left to be treated in the US. So I guess, I’m just curious what is it at the moment that’s the main factor to getting those patients on drug, given the broad access that you seem to have secured? And can you help us think about, perhaps how we should think about that access improving during the course of 2020?

And then just moving on for a minute to Piqray. Obviously, a pretty impressive second quarter sales number there. I wonder if you can just talk about the testing rates that you’re seeing at the moment. And give us some sort of idea in terms of, I guess, the coverage and the type of patients you’re getting on Piqray at the moment, whether those patients are sort of last line or whether you’re seeing earlier use driven by positive companion diagnostic tests? Thank you.

Vasant NarasimhanChief Executive Officer

Yes. Thanks for the questions, Peter. So on Zolgensma, in terms of the — you’re correct that we continue to have a prevalent population available to us. And because again, we are still climbing in our coverage of the incident population, every time we don’t capture an incident patient, they become part of a prevalent pool that remains available to us for a period of time. So that dynamic, we think, will continue for some period until we achieve our goals of having very high coverage of the incident population.

Now in terms of the dynamics on the prevalent population in switches, there’s a combination of factors. I think, one, it’s just continuing to work on the access environment, particularly in Medicaid. We’re at 30%. Our goal is to increase that now over the course of next year, and that should enable us, hopefully, to be even more successful in the prevalent population.

Second is to continue the journey on patient and physician education, particularly around our long-term data. I think the only reasons we hear any reluctance to make the switch is because typically right now insurers are not covering both medicines. So if you make the switch, you are making the switch on to the gene therapy. And so continuing to educate physicians and patients on it. But we’re seeing, I think, very strong uptake with respect to that as well. I think those are the two key dynamics, access and the continuing patient advocacy and education.

And now in terms of the access dynamics, as I think I’ve already described, we have very good coverage in the private. Public should climb, and our focus right now is to continue to push the uptake of newborn screening.

Piqray, I’ll hand it over to Susanne.

Susanne SchaffertPresident of Novartis Oncology

Thank you, Vas. Thank you, Peter, for the questions. Actually, we’re very excited about our launch in Piqray. As you know, these patients that have a PIK3CA mutation usually have a very poor prognosis. So we see very high interest, a very positive feedbacks from physicians. We have reached 49 million year-to-date and have more than 1,000 patients that receive Piqray now. In terms of coverage, we see very broad coverage for the treatment but also for the testing. As you know, Piqray as treatment but also PIK3CA testing is covered in the NCNN guidelines. And we are very pleased also with the uptake of the testing rates.

Specific to your question, what patients are currently treated on Piqray? Well, there might be a few patients that are in later line. But as you know, this is metastatic breast cancer patients with poor prognosis, so we expect that the majority of patients come really from second-line treatment. And we expect continued demand and are very pleased with the performance so far.

Vasant NarasimhanChief Executive Officer

Thank you, Susanne. And we’re very excited about taking Piqray into additional indications over time as well.

Next question operator?

Operator

Thank you. Our next question comes from the line of Keyur Parekh from Goldman Sachs. Please ask your question.

Keyur ParekhGoldman Sachs — Analyst

Hi. Good afternoon. Two questions, please. One, Vas, as you talk about the momentum for the business into the nine months of this year, can you help us think about how you see that momentum developing into 2020? What might be things that might accelerate versus what might be things that might pull you back into next year? That’s question number one.

And then question number two, coming back to Zolgensma. Can you give us a sense for how much of that $160 million was from US versus ex US? And how should we think about the reimbursement speed in the ex-US markets for next year? Thank you.

Vasant NarasimhanChief Executive Officer

Thank you, Keyur. So on 2019 versus 2020 dynamics, as Harry described some of the dynamics for Q4, I think you’ll have a similar set of factors that will impact us in 2020. On the one hand, you’re going to see our launches, we’ll continue to drive with great energy and as well as our growth drivers. We’ll continue the strong productivity programs, where our goal has been to deliver $2 billion in absolute savings across NTO, our manufacturing as well as procurement as well as Business Services. But at the same time, we have in oncology a set of potential generics or generics that have already of course launched, primarily Afinitor, Exjade — Exjade, Jadenu, I think are the ones highest on our mind. So I think we’ll just have to see how those dynamics play out, but we think we’ll set up well for a strong 2020 as well and we look forward to providing full year guidance in January.

Now with respect to Zolgensma, what I can say, I think I would — probably the accurate thing to say, is the vast majority of sales come from the US We have had paid patients from select European countries that have put already in place programs. Of course, the French ATU is one such program, but there are other countries that have already reimbursed patients, including Portugal and Germany, among others. There is broad reimbursement right now for nusinersen in Europe. So we are, of course, endeavoring to have rapid — as rapid as possible reimbursement uptake as we can. We think there will be strong advocacy for the use of Zolgensma, and we think we can make very compelling cost-effectiveness arguments for payers in Europe and other parts of the world with the medicine that hopefully will enable rapid access and rapid reimbursement.

Thank you for the question. Next question operator?

Operator

Thank you. Our next question comes from the line of Andrew Baum from Citigroup. Please ask your question.

Andrew BaumCitigroup — Analyst

Thank you. A couple of questions please. I’m not sure if John Tsai is on the line, but I’d be curious as to his view. Both yourselves with Entresto and Biogen with aducanumab are filing data on subgroups from two trials which failed to hit their primary endpoint. In the context of some recent comments from Bob Temple, should we be thinking of this as the beginning of a new paradigm in willingness of the FDA to go further with subgroup analysis than they may have done previously in terms of trials which failed to meet?

And then second, on Cosentyx, looking at the IQVIA data, the drug seems to have stalled in terms of both NRx and TRx approximately since the launch the launch of Skyrizi. Is there some issue with sampling here? Or is there something else going on to explain the paradoxical outlook? Thank you.

Vasant NarasimhanChief Executive Officer

Yes. Thank you, Andrew. So on Entresto, John?

John TsaiHead of Global Drug Development & Chief Medical Officer

Yes. Thanks for the question, Andrew. I think it’s very insightful you picked up some of the deliberations from Bob Temple. I think, one, when we look at Entresto and the results, obviously, we talked about the heart failure with preserved ejection fraction population that currently has no treatment. So given that’s the underlying basis, we are having discussions with the agency, and they have expressed interest in seeing the results. So we’ll have continued dialogue with them in terms of the best way to move forward. And we’ll submit those before the end of the year. That’s the approach we’ll take for Entresto.

Vasant NarasimhanChief Executive Officer

And if I could just add, I think one important element, I can’t comment on the other filing you mentioned. But I think on Entresto, one important element is this is an approved medicine in reduced ejection fraction heart failure with a sizable safety database and a patient population that we studied that’s adjacent to the original patient population and, I would say, also with unclear boundaries. The 40% ejection fraction versus 60% ejection fraction, where do we cross the line from reduced ejection fraction to preserved ejection fraction?

It’s notable, 35% used to be the cutoff, and we’ve moved to 40% for reduced ejection fraction. So we’re in a gray zone here. And I think that’s part of the reason we believe the regulators encouraged us to file the data and then take the next steps because there may be ways to look at this to enable patients to benefit, particularly building off an approved medicine with a long track record.

Now with respect to Cosentyx NRx, Marie-France?

Marie-France TschudinPresident of Novartis Pharmaceuticals

So actually, we’re delighted with our performance with Cosentyx. It’s growing strongly, actually faster than the market in dermatology and rheumatology. It’s normal for us to see some of these fluctuations in NBRx, but if we look across the year, the NBRx is very solid. In the US, we’re actually growing twice the market in both derm and rheum. Skyrizi is expanding the market, as other launches have done, but it’s taking share from older agents, namely the anti-TNFs. Cosentyx is actually more than just a great dermatology drug, it’s a complete treatment. Two thirds of the patients have additional manifestations beyond skin, and given the complete treatment or a strong first-line access, we’re confident in the potential of this product going forward.

Vasant NarasimhanChief Executive Officer

Yes. And if I could just highlight again, we’ve looked, I think, tried to look as carefully as we can about the dynamics. And when we looked at the NBRx data and the TRx data across — in dermatology, we feel very good about the trend set that we’re seeing. And we’ll look forward to continuing to demonstrate that in quarter four and then into 2020.

Next question?

Operator

Thank you. Our next question comes from the line of Eric Le Berrigaud from Bryan Garnier. Please ask your question.

Eric Le BerrigaudBryan Garnier — Analyst

Yes, good afternoon. First question is about amortizations of intangible in pharma. There are some significant swings here. In the third quarter, it was significantly up. Going forward, what should we expect? Is it the first sign of AveXis of a full quarter being fully amortized? And so should we expect $700 million to $750 million per quarter to persist over the coming quarters?

And the second question is about Entresto. My understanding is that in the US, you suffered from some negative inventory movements. Could you quantify that for the second quarter and maybe give some explanation whether it corresponds to any price increase or some rebate discounts in anticipation for that or these kind of things? Thank you.

Vasant NarasimhanChief Executive Officer

Thank you, Eric. On amortization of intangibles, Harry?

Harry KirschChief Financial Officer

Yes. Eric, so amortization of intangibles, of course, what you see is the acquired medicines, so to say, to increase the amortization piece according to the expected patent life that we assume in the accounting according to IFRS. So we have AveXis and we have Xiidra coming in which added, of course, then to the amortization. So that’s the level of amortization I would expect going forward. Of course, always pending potential M&A actions, right, which then would add to it. And of course, over time some of the older assets would come off, but that’s right now roughly the level that we see also going forward.

Vasant NarasimhanChief Executive Officer

Thanks, Harry. And then on Entresto dynamics, Marie-France?

Marie-France TschudinPresident of Novartis Pharmaceuticals

So we have seen some seasonal effect in Q3, but this is completely in line with previous years. We’ll always see some stock and trade fluctuations and we have seen some revenue reduction true-ups in Q3. However, if we look at demand, it’s really strong. Our TRxs are up 50% year-over-year. We are expecting a really strong Q4 and we’re comfortable with our full year consensus.

Eric Le BerrigaudBryan Garnier — Analyst

Thank you.

Vasant NarasimhanChief Executive Officer

And maybe, Harry, you want to just dimensionalize, just a look at the question on inventory versus revenue deduction?

Harry KirschChief Financial Officer

Yes. It’s roughly half-half. Also, on the inventory, I just want to reassure you, this is sometimes one or two days of inventory we talk here. Overall, there’s hardly any fluctuation on the company or the key brands that would be any cause of concern. It’s one of our key control as you know, each quarter, each month to ensure that we see overall sales in line with demand. So when a couple of effects come together, like a bit of revenue reduction and maybe one or two days less stock in trade, that month you have a bit of an effect, especially as we also have in quarter three always a bit lower new scripts on Entresto. So nothing to be concerned about. Very strong underlying demand.

Vasant NarasimhanChief Executive Officer

Thank you, Harry. Next question?

Operator

Thank you. And our next question comes from the line of Matthew Weston from Credit Suisse. Please ask your question.

Matthew WestonCredit Suisse — Analyst

Thank you very much. Two questions, if I can. The first is on Zolgensma and the strong data. Vas, I think you said that after we’d seen the second dose you would discuss with FDA whether that was sufficient for filing or whether or not we had to wait for the highest-dose data. I wonder whether those conversations have now been had post-World Muscle and what the decision was between waiting for that third dose?

And then secondly, a question around share buybacks. Clearly, the cash flow remains extraordinarily strong with a very strong earnings growth at the business. Obviously, the Alcon — or the program associated with limiting the dilution of Alcon is now complete. But I wondered philosophically how you felt about further additional share buybacks.

And then if I can cheat a quick third one, Harry. A feature of Q2 was writing back prelaunch inventory and it had a very meaningful impact on margins. I wondered if we were going to see something similar with Beovu in 4Q.

Vasant NarasimhanChief Executive Officer

Thank you, Matthew. So first on Zolgensma, we submitted the data to FDA with respect to the first two doses that we presented at WMS. And we still have not had the conversation yet with FDA. As soon as we have that conversation and can clarify the filing approach, we’ll provide that. And I would say as well, we are making progress as well on the high-dose if it is in fact, needed. But our position is that we have data needed and we’ll hopefully have that conversation with FDA in a positive way.

With respect to share buybacks, Harry?

Harry KirschChief Financial Officer

Thank you, Matthew, and also for noting the strong free cash flow we have which is always of course a key focus area for us and we are doing quite well. Always improvement areas of course, but wonderful $9.4 billion, the first nine months, so going well there. And overall, share buybacks, I continue — we continue to see share buybacks as part of our capital allocation priorities, but it’s also number four. So after we have completed this one, the $5 billion that we announced last year in June, we completed in quarter three, we of course continue to look at our capital overall.

And just to remind everybody on the phone, after the first priority being organic investment, the second being strong and growing dividend and third being bolt-on up to basically 5% of our market cap, the fourth is share buybacks. And so we will continue to evaluate this as we go forward. In case we would have specific share buyback program to lower the underlying share count, we would make an announcement publicly. We have an ongoing commitment to mitigate any diluting effect from our employee participation programs, so you will see ongoing some share buybacks as we buy back employee shares. So let’s see. It will continue to be part of the future capital allocation priorities, but it’s number four. And we would always announce when we do a specific one.

Vasant NarasimhanChief Executive Officer

And Harry, inventory movements on Beovu?

Harry KirschChief Financial Officer

So this is the launch provision as we, prior to approval, write off any launch inventory according to prudent IFRS accounting rules. There will be some, but I don’t see this — that this would impact as you have seen before. So usually, our pre-launch inventory, the cost of goods are quite low. And therefore, you don’t see these effects and they level out over years.

Vasant NarasimhanChief Executive Officer

Maybe I’ll take the opportunity, Marie-France, do you want to provide some color of the conversation you had, Beovu at AAO and some of the excitement that you saw on the product?

Marie-France TschudinPresident of Novartis Pharmaceuticals

Yes. So we’re very thrilled about the feedback we got at AAO. We spent some time there and obviously met with some of the top retina specialists in the US I mean what we’re hearing from physicians is they really make their decisions on the ability of a medicine to dry better on the dosing interval, on the safety and on the cost. And what we know with Beovu is that we really believe we’ve got a product that can deliver on these four dimensions, providing greater fluid resolution, longer intervals for patients, uncompromised safety. And definitely, what we’ve heard from AAO is that physicians were very impressed on how we priced the product. We really got great feedback. They’re excited to use Beovu and want to treat patients quickly. A lot of them described Beovu, and I’ll just use a quote, as a “generational leap.” So we’re very excited, we believe Beovu will be a major player in the wet AMD space and beyond.

Vasant NarasimhanChief Executive Officer

Great, thank you Marie-France. So we’ll keep working to demonstrate that in the coming quarters. Next question, operator?

Operator

Thank you. And our next question comes from the line of Steve Scala from Cowen. Please ask your question.

Steve ScalaCowen — Analyst

Thank you. Two questions. First, on Zolgensma. It was launched with a pay-for-performance program. What portion of dosed patients have fully achieved the necessary milestones required by the pay-for-performance program so any clawback is now not possible? That’s the first question.

Second question is on fevipiprant. What can you say about the performance on FEV1? Was it just inconsistent? Or was it a complete miss? It would seem less likely that a drug that fails on FEV1 hits on exacerbations. Nucala did just that, but its FEV1 data was inconsistent and not a complete miss. So, thank you.

Vasant NarasimhanChief Executive Officer

Thanks, Steve. On Zolgensma pay-for-performance, what I can say is we have that feature and many if not all of our contracts with private insurers. I think very few, if any, have yet met the milestones associated with those contracts. I would say as well, though, that we have now presented data with patients out beyond five years, maintaining all motor milestones. The average patient now from the START Study is beyond four years of age, and we continue not to see deterioration in the motor milestones gained in those patients treated with Zolgensma.

Harry KirschChief Financial Officer

Vas, if I just add.

Vasant NarasimhanChief Executive Officer

Yes.

Harry KirschChief Financial Officer

If I just add, Steve, on the revenue recognition principals, of course, on the very small portion of patients that would be on that pay-for-performance. We ensure that we have appropriate revenue deductions from a statistical model so to say, which initially we have from the clinical trials and which we would update every quarter, according to real-world, which we expect to be close to clinical trials. So revenue deductions are already taking this into account and are very prudently managed.

Vasant NarasimhanChief Executive Officer

John, on the fevipiprant ZEAL?

John TsaiHead of Global Drug Development & Chief Medical Officer

Thanks for the question, Steve. I’m not going to go into the details of the fevipiprant study results. But what I will say is that we’re currently in the process of really analyzing the results. And one bit of color on it is, we’re not surprised by the results that we received in the ZEAL 1 and ZEAL 2 studies. As you know, these studies were conducted in a moderate asthma patient population and that was across a broad unselected population and it was not stratified by eosinophil count. So that was the basis.

Our original intent in terms of filing was always looking at the severe population and especially looking at the elevated eosinophil count. Given that that’s our focus, we’ll look forward to sharing the results in the first quarter as well as sharing the results of LUSTER 1 and LUSTER 2, which will form the basis of our filing in the first quarter of next year.

Vasant NarasimhanChief Executive Officer

Thanks, John.

Steve ScalaCowen — Analyst

Thank you.

Vasant NarasimhanChief Executive Officer

Next one, operator?

Operator

Our next question comes from the line of Florent Cespedes from Societe Generale. Please ask your question.

Florent CespedesSociete Generale — Analyst

Good afternoon, gentlemen. Thank you very much for taking my questions. Two quick ones. First on respiratory. Could we have your view on the respiratory franchise strategy going forward given the fevipiprant results and the products approvals expected next year? And if you can explain the situation in Europe versus the situation and your strategy in the US?

Second question for Harry on the Sandoz margin. How sustainable is the Sandoz operating profit margin improvement? How should we extrapolate the Q3 performance? Or in other words, what is the underlying growth or operating profit improvement for Sandoz this quarter? Thank you.

Vasant NarasimhanChief Executive Officer

Thank you, Florent. I just want to say it’s ladies and gentlemen now, at least for Novartis, so we have almost 50-50 representation in the room. So on the respiratory franchise, I think when you look at it, we have positive results now for QVM, the triple in asthma as well as QMS, which would be a LABA ICS in asthma. That would be built on top of Ultibro, which is our LABA/LAMA in COPD. So we have a broad portfolio of inhaled medicines, and we are now looking at the optimal way to launch that entire respiratory portfolio.

Clearly, the final results from fevipiprant will shape a lot of our thinking. Our overall strategy in respiratory was to move toward more specialty respiratory and severe respiratory, building on our strength from Xolair. And our ideal positioning would be to have Xolair, fevipiprant, then having QVM as an option for patients before they move on to the more advanced therapy. So we’ll see how that evolves. We continue to have a research program looking at diseases like IPF, sarcoidosis, pulmonary arterial hypertension as well. I think we’ll have a better view on our longer-term outlook in the respiratory franchise in 2020.

Now with respect to Sandoz and margins, Richard?

Richard SaynorCEO of Sandoz

Thank you, Florent. The core op — I mean, clearly there was exceptionally strong result for the quarter, reflecting good underlying performance, but also a noticeable impact of US onetimers, particularly Medicaid gross-to-net adjustment. The core growth margin, really driven by favorable product mix, strong underlying growth from the Biologics business growing at 27% and the geographic mix, plus the ongoing transformation of productivity improvements as well as the positive impact of the Medicaid gross-to-net, partly offset clearly by the continued price erosion particularly we’re seeing in the US Our goal is to continue to drive margin improvements as we drive the operational focus. But clearly, we don’t make specific forecasts. And in 2020, we’ll give you guidance for going forward.

Vasant NarasimhanChief Executive Officer

Great. Thank you, Richard. And Richard, any early perspectives on Sandoz and how you see things progressing?

Richard SaynorCEO of Sandoz

No. I mean clearly, we’re on track with the Sandoz transformation. We have seen a very engaged organization that’s very growth-orientated with a lot of work going on in terms of our supply chain, our alignment. And we are noting that transformation is really much on track, but this is a multiyear journey in terms of building a generic-focused business, which I look forward to talking to you about later.

Vasant NarasimhanChief Executive Officer

Great. Thanks, Richard. Our next question, operator?

Operator

Our next question comes the line — from the line of Tim Anderson from Wolfe Research. Please ask your question.

Tim AndersonWolfe Research — Analyst

Thank you. Just going back to fevipiprant. Would you — I guess you still sound quite bullish on the program. You did hit FEV1 in your Phase II trial. My question to you is, are you saying that the probability of success in hitting results in LUSTER are just as high now as they would have been before you knew the results of ZEAL? It seems to me that not showing an FEV1 benefit has to be a negative harbinger of sorts on what to expect from the next round of trials.

And then just a quick question on Zolgensma. Just the number of patients treated, do we just simply take sales in the quarter divided by $2 million? Or can you actually give us the actual number of patients?

Vasant NarasimhanChief Executive Officer

Thanks, Tim. Just on fevipiprant just to, I guess, clarify. When you go back to the Phase II studies, the DP2 class has been, I think, well studied also in our hands. When we studied mild-to-moderate patients in various contexts, we didn’t see a — we did see some FEV1 benefit. We didn’t see a significant benefit. It was only when we studied patients in a publication we published at ERS a few years ago and that looked at high-use eosinophil patients that we saw the benefit. So I think it’s important context. ZEAL 1 and ZEAL 2, LUSTER 1 and LUSTER 2 are very separate efforts. ZEAL 1 and ZEAL 2 is looking at this mild population — moderate population, I should say, not stratifying for eosinophil.

LUSTER is looking at the severe population, looking at the high, primarily hopefully looking at it with a positive result in the high-use eosinophil population, as you’ve seen with the various Biologics. The ZEAL result is largely in line with what we saw in Phase II. It was requested of us as it’s been requested of others to look at a less severe population. I don’t think there’s a read-through. I can’t say we’re more or less bullish about LUSTER 1 and LUSTER 2. LUSTER 1 and LUSTER 2 is just a different patient population.

With respect to Zolgensma, you’d have to divide the total sales by the net pricing that we’ve achieved and also look at our US-EU mix. But you can think about we’re in the range of 100 patients treated that currently under the paid program. We also, of course, have many patients that were previously treated in the Managed Access program as well as the ongoing clinical trials, but I think roughly 100 patients treated to date around the world is a reasonable number, give or take.

Next question, operator?

Operator

And our next question comes from the line of Richard Parkes from Deutsche Bank. Please ask your question.

Richard ParkesDeutsche Bank — Analyst

Hi. Thank you very much for taking my questions. Firstly, I’m just trying to understand a little bit better the Mayzent onboarding issue. I’m just trying to understand why Mayzent would be any different from any other MS therapy. It sounds like reimbursement access isn’t the issue here. So could you just confirm sort of the specifics there and whether it’s a logistical issue rather than reimbursement access. So that’s first question.

Then the second question, just on Cosentyx and non-radiographic axial spondyloarthritis. Obviously, penetration rates are partly low due to the lack of approved therapies in that setting. But I think biologic drugs have been available for a little bit longer in Europe. So can you discuss what experience in Europe tells us about the likely barriers to uptake in that setting and what you might be able to do to go about improving on those levels of penetration? Thanks very much.

Vasant NarasimhanChief Executive Officer

Thanks. On Mayzent uptake, Marie-France?

Marie-France TschudinPresident of Novartis Pharmaceuticals

Yes. So — the NBRx that we see shows that physicians see the value in this product. We do see a 90-day lag between start forms and paid scripts and this is due to baseline testing and free drugs. However, now that we’ve been in the market for a couple of months, we do see opportunities to accelerate this. I think if I go back to what I said in Q2, we have always said that the first 12 months with Mayzent would be about education. Physicians recognize that these patients are progressing.

The challenge is that they are not diagnosing SPMS, and that is because there’ve been no effective therapies until now. So this means we need to change habits, and that takes time. We’re very committed to Mayzent because patients need it. It’s really the only DMT with proven efficacy in this population, so we just need to work, continue to work on education and continue to work to accelerate the pull-through.

Vasant NarasimhanChief Executive Officer

I think one element that’s specific to Mayzent is the need for a certain genetic testing, which we’re now working to accelerate as well. That’s just one component. But I think we really view this as a logistical operational challenge. We’re seeing strong interest and strong demand from the patient physician community. Now on your question on non-radiographic axial SpA, you are correct there are TNFs that have been approved in the past in this indication in Europe. I think the key things for us are going to be making a strong access argument around the world in the US and in Europe and then improving diagnosis rates. When you look at the diagnostic inclusion criteria, it does involve an MRI.

And so I think one of the key things for us is going to be to work through patient — physicians understanding how to identify patients that might be in what is really an early stage of ankylosing spondylitis, take the appropriate measures to evaluate the patient and then hopefully get them on the medicine.

Thank you, Richard. Next question?

Operator

Our next question comes from the line of Richard Vosser from JPMorgan. Please ask your question.

Richard VosserJPMorgan — Analyst

Hi. Thanks for taking my questions. So two, please. First just going back to Sandoz. I wondered if you could give us the contribution from the oral solids business at the nine months, both on the sales and operating profit, and also give us the idea of the contribution from the lack of depreciation to the margins from that business for the nine months.

Second bit on — and linked to that is just when do you we think the disposal to Aurobindo will happen now? Is that going to be by the end of the year? Or should we continue to think this contributing to numbers in 2020?

And then second question, just on Sandostatin LAR. I noticed that you are not commenting about that in terms of an impact on generics. Just maybe you could give us some flavor of the impact that you’re seeing in Europe, the proportion of the rest of world sales that are from Europe and what’s happening ex Europe, what sort of growth are you seeing ex Europe that may be balancing any impact from the generics in Europe? Thanks very much.

Vasant NarasimhanChief Executive Officer

So Richard, on the Sandoz mix from oral solids versus biosimilars and other businesses.

Richard SaynorCEO of Sandoz

So, thank you. Clearly, the Biologics business accounts for roughly, I guess, about 20% of the total business within Sandoz, give or take. And clearly, the biologics underlying growth is about 27%. So it’s accelerating quickly versus, I guess, a still growing but flattish oral solids business. On your second part to that question, around Aurobindo clearly we are working closely with the authorities and with Aurobindo to close and hopefully we’ll get that approved by the authorities within the next month or so.

Vasant NarasimhanChief Executive Officer

And Harry, I think we also add a question on lack of depreciation. Any comment?

Harry KirschChief Financial Officer

Yes. That’s a relatively small amount. We’ll get back to you on that one. We have mentioned it before, but it’s not very significant.

Vasant NarasimhanChief Executive Officer

And then on Sandostatin LAR, Susanne?

Susanne SchaffertPresident of Novartis Oncology

Sandostatin sales were broadly in line with last year. And when you put the different markets, there is still growth in the US So the product’s holding very well. While in Europe, we see some first erosion from generics. To give a little bit more color, so we know there is one generic company having marketing authorization for Europe, and they are now working through the local or national ratifications. We know that UK, Spain, France, Switzerland and Germany have approvals. And we see first commercial activities in Germany, where we see first erosion of our product.

So going forward, you have to expect very focused erosion in some markets. That’s what we expect. For the US, we have no news at this point. We continue to monitor the situation closely. But when you ask for how you would model that, we would expect there is only very limited generic entry, probably one company only, so we would see a more gradual erosion if a generic enters.

Vasant NarasimhanChief Executive Officer

Thank you, Susanne, I just want to highlight this is a very complex manufacturing process. There is, as far as we know, only one potential generic entrant, depending on the market in Europe and the US and not a product that’s easy to supply in large volumes as well. So these are all important factors to consider when you think about Sandostatin LAR and the formulation.

Thank you, Richard. Next question?

Operator

Thank you. And our next question comes from the line of Emmanuel Papadakis from Barclays. Please ask your question.

Emmanuel PapadakisBarclays — Analyst

Thanks for taking the question. Maybe one on Aimovig, it seems to have had a somewhat slower start in Europe and it seems to be perhaps slowing somewhat in the US So just your perspectives on market trajectory of development from here and if you’re able to give us any update on litigation that will also be helpful. And the second should be relatively quick one, if you could give us any updates on the status of your pegfilgrastim filing in the US, that would also be helpful.Thank you.

Vasant NarasimhanChief Executive Officer

Great. So on Aimovig, Marie-France?

Marie-France TschudinPresident of Novartis Pharmaceuticals

So to answer your question on Europe, I mean where we’ve seen reimbursement, we’ve seen very strong uptake. If I take Germany as an example, we’re doing extremely well in that market. Getting reimbursement in Europe has been difficult as we anticipated, given also the comparator to the product. In the US, actually, our performance is very good. We remain well differentiated. We’ve got 4.5-year data that confirm efficacy and the safety. We’ve got good access. And since we were first to market, it is a product that is familiar to physicians. We do expect Aimovig’s performance to continue. And we will continue to pursue reimbursement outside of the US.

Vasant NarasimhanChief Executive Officer

And on litigation, we have no material updates on the litigation. We’ll of course keep everyone you up-to-date. On pegfilgrastim, Richard?

Richard SaynorCEO of Sandoz

Thank you, Emmanuel. Clearly, we remain very confident in the quality of our dossier and we expect that the FDA should complete its review very soon.

Vasant NarasimhanChief Executive Officer

Great. Thank you. Next question, operator?

Operator

Next question coming from the line of Laura Sutcliffe. Please go ahead.

Laura SutcliffeUBS — Analyst

Hello. Thanks for taking my questions. Firstly, one on Zolgensma, please. You said that two thirds of patients on Zolgensma — incident patients on Zolgensma who have been given Zolgensma where newborn screening is being implemented. Do you have any sense of why it’s at that level? Is that just a reflection of current Medicaid access? Or is there anything else at play there?

And then secondly, could you just remind us of your current situation with respect to a biosimilar etanercept at Sandoz? Any thoughts you have on a potential launch down the line there?Thank you.

Vasant NarasimhanChief Executive Officer

Thank you, Laura. So on Zolgensma, I think when there’s newborn screening in place, we see, one, a high awareness of the potential of gene therapy to lead to a definitive, hopefully definitive, treatment for these patients. And so I think with gene therapy — sorry, with newborn screening, there tends to be a high correlation with high degrees of awareness.

When patients are identified later on, they tend not to be at specialized centers or we have to then work a little bit harder to get the switches to happen. So I think that’s probably why we see that effect. Our aspiration is regardless of whether newborn screening or identified otherwise, we believe Zolgensma should be the first choice for all of those patients. And our aspiration is to be above 90% coverage of all of those early incident patients in SMA.

With respect to etanercept, Richard?

Richard SaynorCEO of Sandoz

Again, thank you. So first nugget, clearly, Erelzi was approved by the FDA in 2016, but not launched due to the pending patent litigation with Amgen. The US District Court of New Jersey ruled against us in the patent litigation on August 9th. Now we respectfully disagree with the ruling. And while valid intellectual property should clearly be respected, we believe patient — patents in this case are invalid. We’ve appealed already to the US Court, Federal Circuit, and the parties have agreed to an expedited appeal. And we look forward to bringing Erelzi to US patients as soon as possible. And clearly, we’ll update you of any progress.

Vasant NarasimhanChief Executive Officer

And as soon as we have more color on when a potential decision might happen, we’ll, of course, update all of you. Thank you, Laura for your questions. Next question, operator?

Operator

Next question is coming from the line of Seamus Fernandez for Guggenheim. Please go ahead.

Seamus FernandezGuggenheim — Analyst

Thanks for the questions. So just a couple here. On fevipiprant I don’t want to overread into the fevipiprant situation, but as I look at your slide deck, you specifically comment on a planned filing in 2020. And then in your appendix, it says that the LUSTER 2 trial is complete. Just a question here, do you have any data in hand from the LUSTER trials on exacerbation? Or is that review to be completed? It just seems like that there’s an implication that in the eosinophil-high patient population, maybe there’s an effect but you’re waiting for LUSTER 1?

And then the second question, really, is to kind of focus in on the way that you see Beovu ramping. Maybe you could just help us understand the launch trajectory for Beovu and how we’re going to see revenue kind of grow — coming into the model. And maybe you can just metric that for us versus the kind of launch that we saw with Eylea. Thanks so much.

Vasant NarasimhanChief Executive Officer

Yes. So on fevipiprant, first, it’s important to note that in order to file in the severe population, we need both studies, the LUSTER 1 and the LUSTER 2 study. So in order for us to make a determination, we also need to see the pooled analysis across the two programs. We have locked — as you rightly point out, we have locked the LUSTER 2 database.

So we do have the initial readout from that study, but we’re awaiting now the LUSTER 1 readout to understand where the overall program in the pooled analysis as well sits, all of the elements that would be required for a regulatory filing. We also have an additional study called the SPIRIT study, which is required from a safety standpoint as well. So once we have a clear perspective on all of these studies, we’ll be able to provide an update in Q1.

On Beovu, Marie-France?

Marie-France TschudinPresident of Novartis Pharmaceuticals

Yes. So on Beovu, I will just really reiterate what we’re hearing from the marketplace, which is that physicians are very excited to use the product. We know from clinical practice that fluid is the number one factor for treatment and for switching decisions. We believe that Beovu will convince, given the HAWK and HARRIER data, and no doubt it will convince even more in clinical practice. We’ve seen a lot of positive feedback from AAO. I think what I would say is Beovu meets physician needs for greater fluid resolution in these patients’ needs for greater treatment intervals. And we believe that Beovu will be a major player. I’ll also say that I believe we’ve got a world-class team in place in the US and that we’ll see a really strong launch with Beovu.

Vasant NarasimhanChief Executive Officer

All right. Thank you, Seamus. Next question, operator?

Operator

The next question is coming from the line of Simon Baker from Redburn. Please go ahead.

Simon BakerRedburn — Analyst

Thank you for taking my questions. Two, please. Firstly, on Zolgensma, I wonder if you could give us a little bit more color on the phrase even distribution of patients by type and age. I’m assuming it’s not dead 50-50. So any more color on there will be useful.

And then sticking with fevipiprant I wonder if you could give any us thoughts on any potential mechanistic reason for the ZEAL result. Is this due to different implication of Th2 cells in moderate and severe asthma? There have been a few papers suggesting that maybe there could be some possible explanation there. So your thoughts on that will be much appreciated.Thank you.

Vasant NarasimhanChief Executive Officer

Yes. Thanks, Simon. For Zolgensma, we’re obviously not providing that granularity of detail, but what I can say is we’ve seen solid uptake in both patients between the ages of one and two and patients between the ages of six months and one year and patients below six months. So we’ve seen, I think, a relatively even distribution across these different age groups. And we’ve seen an even distribution as well between type 1, type 2 and type 3 patients. But those are the numbers — those are the groups we’re talking about when we say an even distribution.

So I’d say, in large part, what we’re trying to indicate is we are seeing approvals for the use of the medicine when prescribed when on label and after taking the appropriate steps with insurers.

Now with respect to this ZEAL results and the mechanism, John?

John TsaiHead of Global Drug Development & Chief Medical Officer

Yes, sure. Thanks for the question. I think you guys all know that fevipiprant is a selective DP2 agent. In that case, it’s not a classic bronchodilator. What we know is that DP2 activation increases with disease. So in fact, as you have more disease, you actually would likely get more response from DP2s. Now just one correlation that you probably know in terms of the biologics or IL-5s, in the moderate population, there is not significant improvement in FEV1. So I think, in this respect, we obviously want to see the results of LUSTER 1 and LUSTER 2 and expect to see better results in the DP2 antagonists for patients with severe population, especially with high eosinophils.

Vasant NarasimhanChief Executive Officer

All right. Thanks, John.

Simon BakerRedburn — Analyst

Thank you.

Vasant NarasimhanChief Executive Officer

Next question, operator? No, actually, Harry, you had one clarification.

Harry KirschChief Financial Officer

Just for Richard. Richard Vosser, you asked about the divested Sandoz US business-related stock depreciation. It is a small number, is about $10 million per quarter. So $30 million year-to-date, $10 million per quarter is the stock depreciation.

Richard VosserJPMorgan — Analyst

Thanks, Vas.

Vasant NarasimhanChief Executive Officer

Thanks, Harry. Next question, operator?

Operator

The next question is coming from the line of Mark Purcell from Morgan Stanley. Please go ahead.

Mark PurcellMorgan Stanley — Analyst

Yeah. Thank you very much for taking my questions.First, on China. Could you please help us understand the outlook for your business in China, framing the opportunities as well as the threats? Clearly very strong growth the more key growth drivers that you highlighted and launches to come as, in terms of Entresto and heart failure and consensus, et cetera. But from the threat perspective, obviously a number of LOEs I presume are coming up, potentially including products such as Galvus. So if you could help us understand the key approval decisions and your out decisions and LOE timings, that will be fantastic. There isn’t a lot on LOE timings outside the US, Europe and Japan in your annual report.

And then secondly on canakinumab, I guess this a bit of a wildcard in your pipeline. Could you comment on the — any interim analyses planned ahead of the primary completion of CANOPY 1 and CANOPY 2 in the first half of 2021? And then just more broadly, in terms of your ambitions on IL-1 beta as a mechanism following the acquisition of the XOMA product. Thanks very much.

Vasant NarasimhanChief Executive Officer

Thank you, Mark. On China broadly, we see it as, obviously, a very important opportunity for the company. We publicly stated we have overall business in IM that’s over $2 billion. Our goal is to at least double that business over the 5-year term. It’s driven entirely by new launches, our ability to launch new medicines.

And I’ll have John comment a bit more on the number of NRDL — number of approvals and NDAs we expect and then maybe Marie-France can give more color on how we’re doing on some of the launches. John?

John TsaiHead of Global Drug Development & Chief Medical Officer

Thanks Vas. As you know, we put a significant effort into China. Already in the last two years, we’ve had 24 NDAs approved. That’s across nine NMEs, new molecular entities. And moving forward over the next — between now and 2023, we expect to have 50 NDA submissions. So in total, with that combination, it’s over 70 NDAs. So a significant effort that we’re putting in behind China over the last two years and over the next couple of years.

Vasant NarasimhanChief Executive Officer

And that fits with our overall belief with the 7 plus 4 initiative to take — expand out of older medicines and free up resources to launch new medicines. We want to be well positioned with all of our portfolio available in China and ready to launch. Marie-France, do you want to give us some more color on how we’re doing on some of those products?

Marie-France TschudinPresident of Novartis Pharmaceuticals

Yes. So first of all, I’ll just comment and say that our China business is growing really well. Our growth rates are in the high 20s. The innovative portfolio is really what’s driving the launch. So if we look at Entresto, Lucentis, Cosentyx, they’re among the five growth drivers for China. Entresto is actually the best primary launch ever. And we do expect to see NRDL listing in Q4. So that should be a big opportunity for China. Cosentyx is also off to a great start, but obviously maintaining patients on an out-of-pocket setting is a challenge. So it is a priority for us to get NRDL listing also in 2020. We also expect NRDL listing for Lucentis and DME and RVO this year. So all in all, again, it’s the innovative portfolio that’s driving the growth. We currently have no products on the 4 plus 7 list, although that may change. And again, what we’re going to focus on is really this innovative portfolio and expect to continue the strong growth.

Vasant NarasimhanChief Executive Officer

Great. Thank you, both. On canakinumab, John, any interim expectations?

John TsaiHead of Global Drug Development & Chief Medical Officer

Yes, so specifically, obviously, we had the PARAGON results readout. One of the areas that we’re looking into is the post-acute —

Vasant NarasimhanChief Executive Officer

No, no, sorry John, not Entresto, canakinumab, the non-small cell lung cancer, first line, second line.

John TsaiHead of Global Drug Development & Chief Medical Officer

Yes, the — what we can say about canakinumab, sorry about the confusion there, for CANOPY trials, CANOPY 1 and CANOPY 2, those are moving forward and recruiting well. We continue to see good results in terms of recruitment. Now what we do see in the adjuvant population is a little bit slower population in terms of recruitment in that study. But I think, balanced what you’re seeing in the marketplace, there’s just last patients that are actually moving forward in the adjuvant population. For CANOPY 1 and CANOPY 2, those are moving forward very well in terms of recruitment. And CANOPY A in the adjuvant population is a bit slower than we expected.

Vasant NarasimhanChief Executive Officer

So we do expect CANOPY-2 particularly, potentially CANOPY-1 to read out in 2021. I’d say more broadly, our efforts in IL-1 beta and the inflammasome are — we are quite bullish on it. Not only did we have the canakinumab program, not only did we bring in a second agent for an IL-1 beta antibody but we’ve also acquired a company called IFM Tre, which has oral inflammasome inhibitors and we are now — that molecule as well as an internal program we’re taking across a range of autoimmune indications, oncology indications, neurological indications. So we would like to own the inflammasome space for the long term and that’s what we are working toward.

So thank you, Mark for your questions. Next question, operator?

Operator

Thank you. Our next question comes from the line of Naresh Chouhan from Intron Health. Please ask your question.

Naresh ChouhanIntron Health — Analyst

Hi there. Thanks for taking my questions. Firstly, on Tasigna which seems to have returned to growth, at least in the US Is it fair to assume that the impact from the TFR data is now played out and we should see sustained growth in the US? And similarly so, in Europe in the coming quarters? And then secondly, the gross margin of Pharma was impacted by the cell and gene therapy investment. Should we expect that to continue well into 2020? Or is this a short-term impact given the Zolgensma uptake? Thanks.

Vasant NarasimhanChief Executive Officer

So I think both questions for Susanne. First on Tasigna, Susanne?

Susanne SchaffertPresident of Novartis Oncology

Yes, on Tasigna we saw indeed very strong growth of 11% in the quarter. So what we can say in the US, as you know, since a while we are focusing our messages around efficacy and around targeting new and switch patients. So we believe this strategy is paying off and we see the situation stabilize and expect modest growth going forward. The Q3 effect is an unusual one because it is artificially high because of inventory phasing versus Q3 in the US So that I would not expect to go forward like that. But overall, we are pleased that Tasigna seems to be stabilized, and we’ll expect modest growth going forward.

Vasant NarasimhanChief Executive Officer

And then cell and gene manufacturing investment?

Susanne SchaffertPresident of Novartis Oncology

Yes. I say we have a lot of focus on improving our manufacturing process. And we are quite pleased that capacity has been gone up by 60% between Q1 and Q3, so making good progress there. We have started to ship out of (Indecipherable), which is the sign for cure side and sign for clinical supply and overall making good progress on that.

Vasant NarasimhanChief Executive Officer

So I’d say our goal is to work back up. I think you were correct, we have with the cell and gene technology had to take some hit on our gross margins, particularly in oncology with CART therapy. Our aspiration is to now start to improve that and get that back up now in the coming year.

Last question I think, operator.

Operator

That’s right. Our last question comes from Mani Foroohar from SVB Leerink. Please ask your question.

Mani ForooharSVB Leerink — Analyst

Hi guys. Thanks for taking my question. I’ve got a quick first one on Zolgensma. Obviously, the expanded access and compassionate care dynamics in the US are very different than other markets. When you think about the bolus phenomenon we’re seeing in the US, could that phenomena actually be more pronounced in some other markets as you roll out in Japan, Europe, et cetera?

And regarding sickle-cell for SEG101, it’s a little different administration profile and reimbursement profile than the oral generic that’s on the market currently but has really impressive clinical data. How do you think about investments in infrastructure and operational expertise that you can bring to bear to commercialize SEG101 across a market that has historically been pretty difficult to penetrate?

Vasant NarasimhanChief Executive Officer

Now thanks for the questions, Mani. On Zolgensma ex US, what we have seen is in certain markets there is a high degree of interest. They’ve already put in access programs in place to enable use of the medicine in multiple patients. So I think in some countries in Europe as well in the Middle East, there could be very strong demand coming very quickly after approval. Difficult to dimensionalize precisely, given that obviously the rarity of the disease, but we do expect there to be similar, let’s call it, pent-up demand effects in overseas markets.

Now on SEG101, Susanne?

Susanne SchaffertPresident of Novartis Oncology

Yes. We are quite diligently preparing for the launch of SEG101, looking forward to getting approval Q1 of next year. And when you ask about our commercial model, there’s obviously big focus on access to get access approval very quickly. I’m very confident about the product because it has an impressive impact on patients. As you know, SEG101 is targeting VOCs, which is the hallmark of the disease. And when you talk to patients, how devastating pain crisis is and seeing that SEG101 could halve episodes of VOCs, I think that’s impressive. That’s also the feedback we get from physicians. So our focus is to work on access, but we’re very confident and looking forward to being ready for launch.

Vasant NarasimhanChief Executive Officer

Thank you, Susanne. So thank you all for joining today’s call. We look forward to seeing you at our R&D day in early December. For those of you who can make it, we’ll be focusing on profiling our next wave of innovation coming out of our early Phase III and late Phase II programs, so you’ll get a sense of the next wave of important medicines we’ll be bringing forward as a company as well as providing more detail on the depth of the programs we have on many of our products, including Cosentyx, Piqray and others that we’ve profiled over the course of today’s call.

Thank you for your interest in Novartis, and we’ll look forward to speaking with you soon. Thank you.

Operator

(Operator Closing Remarks)

Duration: 90 minutes

Call participants:

Samir ShahGlobal Head of Investor Relations

Vasant NarasimhanChief Executive Officer

Harry KirschChief Financial Officer

Graham ParryBank of America — Analyst

Peter WelfordJefferies — Analyst

Susanne SchaffertPresident of Novartis Oncology

Keyur ParekhGoldman Sachs — Analyst

Andrew BaumCitigroup — Analyst

John TsaiHead of Global Drug Development & Chief Medical Officer

Marie-France TschudinPresident of Novartis Pharmaceuticals

Eric Le BerrigaudBryan Garnier — Analyst

Matthew WestonCredit Suisse — Analyst

Steve ScalaCowen — Analyst

Florent CespedesSociete Generale — Analyst

Richard SaynorCEO of Sandoz

Tim AndersonWolfe Research — Analyst

Richard ParkesDeutsche Bank — Analyst

Richard VosserJPMorgan — Analyst

Emmanuel PapadakisBarclays — Analyst

Laura SutcliffeUBS — Analyst

Seamus FernandezGuggenheim — Analyst

Simon BakerRedburn — Analyst

Mark PurcellMorgan Stanley — Analyst

Naresh ChouhanIntron Health — Analyst

Mani ForooharSVB Leerink — Analyst

More NVS analysis

Transcript powered by AlphaStreet

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Psorilax:Gratuito |bruciore crema idratante psoriasi

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HORSHAM, Pa., Oct. 21, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission. Results from UNIFI demonstrate that treatment with STELARA both induced and maintained clinical remission in a significantly greater proportion of adult patients with moderately to severely active ulcerative colitis (UC) compared to placebo.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8627251-janssen-stelara-fda-approval-ulcerative-colitis/

UC is a serious, chronic and progressive immune-mediated inflammatory disease of the large intestine, affecting approximately 910,000 people in the United States. STELARA is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines. The IL-12 and IL-23 cytokines have been shown to play an important role in inflammatory and immune responses.

The pivotal trial included an initial Induction study (UNIFI-I) where patients received a single dose of STELARA 6 mg/kg intravenous (IV) infusion. It was followed 8 weeks later by a Maintenance study (UNIFI-M) where patients received STELARA 90 mg subcutaneous (SC) injections every 8 weeks for 44 weeks. Both studies demonstrated the safety and efficacy of STELARA as a treatment option for patients with moderately to severely active UC, and the design and complete results were recently published in the New England Journal of Medicine.

In the Induction study, 19 percent of patients receiving STELARA achieved clinical remission in just 8 weeks. In addition, STELARA provided patients with rapid relief of their symptoms as 58 percent of patients receiving STELARA experienced a clinical response at Week 8.

In the Maintenance study, 45 percent of patients receiving STELARA were in remission at one year. STELARA also helped patients achieve clinical remission without the use of corticosteroids. At 1 year, 43 percent of patients treated with STELARA were in clinical remission and not receiving steroids.

STELARA is the first and only approved UC treatment to provide improvement of the intestinal lining as assessed by a novel histologic-endoscopic mucosal improvement endpoint. In the Induction study, 17 percent of patients receiving STELARA achieved histologic-endoscopic mucosal improvement at Week 8. In the Maintenance study, 44 percent of patients receiving STELARA achieved histologic-endoscopic mucosal improvement at 1 year. Histologic-endoscopic mucosal improvement is a combined measure that assesses the improvement of the colon at the cellular level through histologic examination and through images observed during colonoscopy. The relationship of histologic-endoscopic mucosal improvement to long-term outcomes was not studied in the clinical trial.

“Ulcerative colitis is a chronic and progressive disease that can have a significant impact on patients, often disrupting their day-to-day lives with frequent and urgent needs for bowel movements that can be accompanied by pain and cramping,” said William J. Sandborn, M.D., Chief, Division of Gastroenterology, and Professor of Medicine, UC San Diego School of Medicine, and study investigator.* “The FDA approval of STELARA for UC represents an exciting milestone, offering patients a new option that has demonstrated improvement of the histology and endoscopic appearance of the intestinal lining, while also offering patients the potential for response and remission without the need for steroids.”

Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, STELARA has received approval for four additional indications: adolescent patients with moderate to severe plaque psoriasis, adults with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease (CD), and now adults with moderately to severely active ulcerative colitis. More than 45,000 patients have been treated with STELARA for CD to-date. Consistent with the approved dosing in CD, STELARA for UC starts with a weight-based, one-time IV infusion induction dose followed by a convenient maintenance dosing schedule of a 90 mg SC maintenance injection every 8 weeks.

Click to Tweet:#BREAKING: The @US_FDA has approved a new indication for STELARA® (ustekinumab). Read more: https://ctt.ac/6HpG2+

“Because of the individual nature of ulcerative colitis, what works for one patient may not work for another. That is why it is so critical that our ulcerative colitis patients have many different treatment options available to them,” said Caren Heller, M.D., MBA, Chief Scientific Officer at the Crohn’s & Colitis Foundation. “The approval of STELARA is extremely important for patients living with moderate to severe ulcerative colitis. STELARA gives patients another option to, hopefully, induce remission and help manage their disease.”

The overall safety profile of STELARA in UC was consistent with what has been observed across all approved indications of STELARA.

“At Janssen, we have a longstanding commitment to developing innovative new options that can help address the unmet treatment needs for those living with immune-mediated diseases,” said David M. Lee, M.D., Ph.D., Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. “With today’s milestone, STELARA has received its fifth FDA approval since 2009, a testament to our unwavering focus on delivering treatments for patients who have limited therapeutic options.”

Janssen will work closely with payers, providers and pharmacy benefit managers to ensure STELARA is broadly accessible and affordable for patients living with UC. Janssen CarePath offers a comprehensive support program that helps patients get started on STELARA and stay on track. Janssen CarePath provides information on insurance coverage, potential out-of-pocket costs, and treatment support, and identifies options that may help make treatment more affordable, including the Janssen CarePath Savings Program for commercially insured patients who are eligible.

About UNIFI
UNIFI is a Phase 3 clinical trial program designed to evaluate the safety and efficacy of STELARA induction and maintenance therapy for the treatment of adults with moderately to severely active ulcerative colitis who demonstrated an inadequate response to or were unable to tolerate conventional (i.e., corticosteroids, immunomodulators) or biologic (i.e., one or more TNF blockers and/or vedolizumab) therapies. Both the Induction and Maintenance studies were randomized, double-blind, placebo-controlled, parallel group, multi-center studies. The Induction (UNIFI-I) study was 8 weeks duration and patients achieving clinical response at Week 8 during the Induction study were eligible to enter the Maintenance study. The Maintenance study (UNIFI-M) was 44 weeks duration. The primary endpoint of the Induction study was clinical remission at Week 8 and the primary endpoint for the maintenance study was clinical remission at Week 44 (1 year after the induction dose) among responders to a single IV STELARA induction infusion.

After completion of the Maintenance study, a long-term extension continues to follow eligible participants for an additional 3 years.

About Ulcerative Colitis
Ulcerative Colitis (UC) is a chronic, progressive inflammatory bowel disease (IBD) that causes ulcerations and inflammation in the large intestine (colon and rectum).1,2 UC affects approximately 910,000 adults in the U.S. and men are more likely than women to be diagnosed.3 The disease is more common among Caucasian people, although it can affect people of any racial or ethnic group. Diagnosis tends to peak between the ages of 15 and 35, although the disease itself can occur at any age.4 Symptoms of ulcerative colitis can vary but may include diarrhea and more urgent bowel movements, bloody stool, crampy abdominal pain, and fatigue. There is currently no cure for ulcerative colitis.5

About STELARA® (ustekinumab)
STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn’s disease; 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis.

STELARA Dosing for Ulcerative Colitis
Adults with ulcerative colitis will receive the first dose of STELARA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. STELARA will then be given as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA, then every 8 weeks thereafter.

See full Prescribing Information for Dosing Information for other indications.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.

IMPORTANT SAFETY INFORMATION
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:

Serious Infections
STELARA® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

  • Your doctor should check you for TB before starting STELARA® and watch you closely for signs and symptoms of TB during treatment with STELARA®.
  • If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA®.

You should not start taking STELARA® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA®, tell your doctor if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweats, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinate more often than normal
    • feel very tired
  • are being treated for an infection.
  • get a lot of infections or have infections that keep coming back.
  • have TB, or have been in close contact with someone with TB.

After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above). STELARA® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and interleukin 23 (IL‐23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also be more likely to get these infections.

Cancers
STELARA® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA®. Tell your doctor if you have any new skin growths.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions
Serious allergic reactions can occur. Stop using STELARA® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Lung Inflammation
Cases of lung inflammation have happened in some people who receive STELARA® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with STELARA®.

Before receiving STELARA®, tell your doctor about all of your medical conditions, including if you:

  • have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS.
  • ever had an allergic reaction to STELARA® or any of its ingredients. Ask your doctor if you are not sure.
  • are allergic to latex. The needle cover on the prefilled syringe contains latex.
  • have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA® should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving STELARA® or one year after you stop receiving STELARA®.
  • have any new or changing lesions within psoriasis areas or on normal skin.
  • are receiving or have received allergy shots, especially for serious allergic reactions.
  • receive or have received phototherapy for your psoriasis.
  • are pregnant or plan to become pregnant. It is not known if STELARA® can harm your unborn baby. You and your doctor should decide if you will receive STELARA®.
  • are breastfeeding or plan to breastfeed. It is thought that STELARA® passes into your breast milk. Talk to your doctor about the best way to feed your baby if you receive STELARA®.

Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed STELARA®:

  • Use STELARA® exactly as your doctor tells you to.
  • STELARA® is intended for use under the guidance and supervision of your doctor. In children 12 years and older, it is recommended that STELARA® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA® at home, you should receive training on the right way to prepare and inject STELARA®. Your doctor will determine the right dose of STELARA® for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA® yourself until you or your caregiver have been shown how to inject STELARA® by your doctor or nurse.

Common side effects of STELARA® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, stomach pain, diarrhea, and joint pain. These are not all of the possible side effects with STELARA®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1800FDA1088.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding STELARA. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

  1. Hendrickson BA, Gokhale R, Cho JH. Clinical aspects and pathophysiology of inflammatory bowel disease. Clin Microbiol Rev. 2002;15(1):79-94.
  2. Crohn’s & Colitis Foundation of America. Inflammatory bowel disease and irritable bowel syndrome: similarities and differences. www.crohnscolitisfoundation.org/assets/pdfs/ibd-and-irritable-bowel.pdf. Published July 2014. Accessed July 7, 2019.
  3. Molodecky NA, Soon IS, Rabi DM, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012;142(1):46-54.
  4. Rubin DT, Ananthakrishnan AN, Siegel CA, Sauer BG, Long MD. ACG clinical guideline: Ulcerative colitis in adults. Am J Gastroenterol. 2019;114(3)384-413.
  5. Danese S, Allex M, van Bodegraven AA, et al. Unmet medical needs in ulcerative colitis: an expert group consensus. Digestive Diseases. 2019;37(4)266-283.

*Dr. William Sandborn was compensated for his work as an investigator on the UNIFI study.
†Johnson & Johnson Healthcare Systems, Inc. is a corporate sponsor for the Crohn’s & Colitis Foundation.

Media contact:
Ania DiAntonio
Mobile: +1 (215) 620-9717

Investor contacts:
Chris DelOrefice
Office: +1 (732) 524-2955

Lesley Fishman
Office: +1 (732) 524-3922

SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson

Related Links

http://www.janssen.com

Psorilax:Spedizione gratuita |crema psoriasi ginocchia

0

Psorilax: prezzo, funziona, recensioni, opinioni, come si usa

  • Lo studio di fase 3 BE VIVID che valuta l'efficacia e la sicurezza di bimekizumab negli adulti con psoriasi a placche cronica da moderata a grave ha soddisfatto tutti gli endpoint secondari primari e classificati
  • Bimekizumab ha mostrato una superiorità statisticamente significativa rispetto a placebo e ustekinumab nel raggiungimento della clearance cutanea e del miglioramento della malattia alla settimana 16i
  • I risultati di BE VIVID sono i primi del programma di sviluppo in fase 3 di bimekizumab in corso

BRUXELLES, 17 ottobre 2019 / PRNewswire / – Informazioni regolamentate – Informazioni privilegiateUCB, un'azienda biofarmaceutica globale, ha annunciato oggi risultati positivi da BE VIVID, il primo di tre studi di Fase 3 che valutano l'efficacia e la sicurezza di bimekizumab, un inibitore di IL-17A e IL-17F, nel trattamento di adulti con moderato-grave psoriasi a placche cronica. I risultati hanno mostrato che dopo 16 settimane di trattamento, il bimekizumab ha raggiunto gli endpoint co-primari di un miglioramento di almeno il 90% nell'indice di psoriasi e indice di gravità (PASI 90) e il punteggio Investigator Global Assessment (IGA) di chiaro o quasi chiaro (IGA 0 / 1).io

Tra gli endpoint secondari chiave, il bimekizumab è risultato anche superiore all'ustekinumab nel raggiungere PASI 90 e IGA 0/1 e superiore al placebo nella clearance cutanea totale (PASI 100 o IGA 0) alla settimana 16.io La valutazione iniziale indica che il profilo di sicurezza di bimekizumab era coerente con i precedenti studi BE ABLE di fase 2.ii

La sicurezza e l'efficacia di bimekizumab non sono state stabilite e non sono state approvate da alcuna autorità di regolamentazione in tutto il mondo. I risultati completi di BE VIVID saranno presentati a tempo debito.

“Questi primi risultati incoraggianti forniscono una forte evidenza che il bimekizumab ha il potenziale per alzare il livello per raggiungere i tassi di clearance della pelle per i pazienti. Il raggiungimento di una pelle chiara è di fondamentale importanza per avere un impatto positivo sulla vita dei pazienti con psoriasi. L'annuncio di oggi segna un'importante pietra miliare nel vasto sviluppo clinico di bimekizumab “, ha detto Mark Lebwohl, M.D., Lead Study Investigator, Waldman Professor of Dermatology and Chair of Kimberly and Eric J. Waldman Department of Dermatology at Icahn School of Medicine at Monte Sinai, New York.

“La psoriasi colpisce tutti gli aspetti della vita di un paziente. Crediamo che il bimekizumab abbia il potenziale per essere una nuova opzione di trattamento significativa per le persone che vivono con la psoriasi”, ha detto Iris Loew-Friedrich, Responsabile dello sviluppo di farmaci e Chief Medical Officer, UCB. “I risultati positivi di BE VIVID di oggi sono solo l'inizio. Non vediamo l'ora di condividere ulteriori risultati del programma di sviluppo clinico di bimekizumab nei prossimi mesi.”

La sicurezza e l'efficacia di bimekizumab sono anche in fase di valutazione nell'artrite psoriasica (PsA), nella spondilite anchilosante (AS) e nella spondiloartrite assiale non radiografica (nr-axSpA).

Informazioni su BE VIVID

BE VIVID è uno studio randomizzato, della durata di 52 settimane, in doppio cieco, controllato con placebo e controllato attivo, progettato per valutare l'efficacia e la sicurezza di bimekizumab in pazienti con psoriasi a placche cronica da moderata a grave. BE VIVID ha arruolato 570 partecipanti con psoriasi a placche cronica per almeno sei mesi prima dello screening e con una superficie corporea interessata di almeno il 10 percento e una PASI di almeno 12.

Gli endpoint co-primari dello studio erano la risposta PASI 90 (definita come un paziente che ottiene un miglioramento del 90 percento rispetto al basale nel punteggio PASI) alla settimana 16 e la risposta IGA (definita come chiara o quasi chiara con almeno una categoria 2 miglioramento rispetto al basale) alla settimana 16. Per ulteriori dettagli sullo studio, visitare BE VIVID su clinictrials.gov.

Informazioni su Bimekizumab

Bimekizumab è un anticorpo IgG1 monoclonale umanizzato in fase di sperimentazione che neutralizza in modo potente e selettivo IL-17A e IL-17F, due citochine chiave che guidano i processi infiammatori.iii IL-17A e IL-17F hanno funzioni pro-infiammatorie simili e si sinergizzano in modo indipendente con altri mediatori infiammatori per guidare l'infiammazione cronica e il danno su più tessuti.iv, v

A proposito di psoriasi

La psoriasi è una malattia infiammatoria cronica comune con coinvolgimento primario della pelle. La condizione della pelle colpisce uomini e donne di tutte le età ed etnie. I segni e i sintomi della psoriasi possono variare, ma possono includere macchie rosse della pelle ricoperte di squame argentee, pelle secca e screpolata che può sanguinare e ispessire, bucciare o rigare le unghie.VI

La psoriasi colpisce quasi il 3 percento della popolazione, ovvero circa 125 milioni di persone in tutto il mondo.VI I bisogni insoddisfatti rimangono nel trattamento della psoriasi. Un sondaggio basato sulla popolazione ha identificato che circa il 30 percento dei pazienti con psoriasi ha riferito che i loro obiettivi primari della terapia, tra cui il controllo dei sintomi, la riduzione del prurito e la riduzione della desquamazione, non erano soddisfatti con il loro trattamento attuale.vii Il mancato raggiungimento o il mantenimento di una completa e duratura clearance della pelle influisce negativamente sulla progressione della malattia e sulla qualità della vita.VIII, IX

Per ulteriori informazioni, UCB:

Comunicazioni aziendali

Relazioni con gli investitori

Comunicazioni del marchio

Laurent Schots,
Relazioni con i media, UCB

Antje Witte,
Investor Relations, UCB

Andrea Christopher,
Immunology Communications, UCB

T + 32.2.559.92.64,
laurent.schots@ucb.com

T +32.2.559.94.14,
antje.witte@ucb.com

T +1.404.483.7329
andrea.christopher@ucb.com

Isabelle Ghellynck,
Investor Relations, UCB

T + 32.2.559.9588,
isabelle.ghellynck@ucb.com

Informazioni su UCB

UCB, Bruxelles, Belgio (www.ucb.com) è una società biofarmaceutica globale focalizzata sulla scoperta e sullo sviluppo di farmaci e soluzioni innovativi per trasformare la vita delle persone che vivono con gravi malattie del sistema immunitario o del sistema nervoso centrale. Con oltre 7.500 persone in circa 40 paesi, la società ha generato ricavi per € 4,6 miliardi nel 2018. UCB è quotata su Euronext Bruxelles (simbolo: UCB). Seguiteci su Twitter: @UCB_news

Dichiarazioni previsionali

Questo comunicato stampa contiene dichiarazioni previsionali basate su piani, stime e convinzioni del management attuali. Tutte le dichiarazioni, diverse dalle dichiarazioni di fatti storici, sono dichiarazioni che potrebbero essere considerate dichiarazioni previsionali, incluse stime di ricavi, margini operativi, spese in conto capitale, contanti, altre informazioni finanziarie, risultati attesi legali, politici, normativi o clinici e altri simili stime e risultati. Per loro natura, tali dichiarazioni previsionali non sono garanzia di prestazioni future e sono soggette a rischi, incertezze e ipotesi che potrebbero far sì che i risultati effettivi differiscano materialmente da quelli che potrebbero essere impliciti da tali dichiarazioni previsionali contenute nel presente comunicato stampa. Fattori importanti che potrebbero comportare tali differenze includono: cambiamenti nelle condizioni economiche generali, commerciali e competitive, l'incapacità di ottenere le necessarie autorizzazioni normative o di ottenerle a condizioni accettabili, i costi associati alla ricerca e allo sviluppo, i cambiamenti nelle prospettive di prodotti nel pipeline o in fase di sviluppo da parte di UCB, effetti di future decisioni giudiziarie o indagini governative, reclami sulla responsabilità del prodotto, sfide alla protezione dei brevetti per prodotti o prodotti candidati, modifiche a leggi o regolamenti, fluttuazioni dei tassi di cambio, variazioni o incertezze nelle leggi fiscali o nell'amministrazione di tali leggi e l'assunzione e il mantenimento dei propri dipendenti.

Inoltre, le informazioni contenute nel presente documento non costituiscono un'offerta di vendita o la sollecitazione di un'offerta di acquisto di titoli, né vi saranno offerte, sollecitazioni o vendite di titoli in alcuna giurisdizione in cui tale offerta, sollecitazione o vendita sarebbero illegale prima della registrazione o della qualificazione ai sensi delle leggi sui titoli di tale giurisdizione. UCB fornisce tali informazioni alla data del presente documento e declina espressamente qualsiasi obbligo di aggiornare le informazioni contenute nel presente comunicato stampa, sia per confermare i risultati effettivi sia per segnalare un cambiamento nelle sue aspettative.

Non vi è alcuna garanzia che i candidati per nuovi prodotti in cantiere passeranno all'approvazione del prodotto o che vengano sviluppate e approvate nuove indicazioni per i prodotti esistenti. Prodotti o potenziali prodotti che sono oggetto di partenariati, joint venture o collaborazioni di licenze possono essere soggetti a differenze tra i partner. Inoltre, UCB o altri potrebbero scoprire sicurezza, effetti collaterali o problemi di fabbricazione con i suoi prodotti dopo la loro commercializzazione.

Inoltre, le vendite possono essere influenzate dalle tendenze internazionali e nazionali verso il contenimento dei costi dell'assistenza gestita e dell'assistenza sanitaria e dalle politiche di rimborso imposte dai pagatori di terzi, nonché dalla legislazione che incide sui prezzi e sui rimborsi biofarmaceutici.

io Dati UCB su file Ottobre 2019
ii Papp K, Merola J, Gottlieb A, et al. Doppia neutralizzazione dell'interleuchina 17A e dell'interleuchina 17F con bimekizumab nei pazienti con psoriasi: risultati di BE ABLE 1, una fase randomizzata di 12 settimane, in doppio cieco, controllata con placebo 2b prova. J Am Acad Dermatol. Agosto 2018; 79 (2): 277-286.e10. doi: 10.1016 / j.jaad.2018.03.037. Epub 2018 mar 30.
iii Glatt S, Helmer E, Haier B, et al. Primo studio randomizzato nell'uomo di bimekizumab, un anticorpo monoclonale umanizzato e doppio inibitore selettivo di IL-17A e IL-17F, nella psoriasi lieve. Br J Clin Pharmacol. 2017; 83 (5): 991-1001.
iv Toy D, Kugler D, Wolfson M, et al. Tagliente: l'interleuchina 17 segnala attraverso un complesso recettore eteromerico. J Immunol Baltim Md 1950. 2006; 177 (1): 36-39. doi: 10,4049 / jimmunol.177.1.36
v Wright JF, Bennett F, Li B, et al. La citochina eterodimerica umana IL-17F / IL-17A segnala attraverso il complesso del recettore IL-17RA / IL-17RC. J Immunol Baltim Md 1950. 2008; 181 (4): 2799-2805. doi: 10,4049 / jimmunol.181.4.2799
VI Federazione internazionale delle associazioni di psoriasi. Disponibile su: https://ifpa-pso.com/our-cause//. Ultimo accesso: 22 febbraio 2018.
vii Lebwohl, M. G., Kavanaugh, A., Armstrong, A. W., & Van Voorhees, A. S. (2015). Prospettive statunitensi nella gestione della psoriasi e dell'artrite psoriasica: risultati dei pazienti e dei medici dalla valutazione multinazionale basata sulla popolazione di psoriasi e artrite psoriasica (MAPP). American Journal of Clinical Dermatology, 17 (1), 87-97.
viii Zachariae H, Zachariae R, Blomqvist K, et al. Qualità della vita e prevalenza dell'artrite segnalate da 5.795 membri delle Associazioni della psoriasi nordica. Dati tratti dallo studio sulla qualità della vita nordica. Acta Derm Venereol 2002; 82: 108113.
ix Moon HS, Mizara A, McBride SR. Psoriasi e psico-dermatologia. Dermatol Ther (Heidelb) 2013; 3: 117-130.

GL-N-BK-PSO-1900031

Cision Visualizza contenuto originale: http: //www.prnewswire.com/news-releases/bimekizumab-phase-3-psoriasis-study-meets-all-endpoints-achieving-significantly-greater-efficacy-versus-placebo-and-ustekinumab- 300940409.html

SOURCE UCB

Codici aziendali: EuronextBruxelles: UCB, OTC-ROSA: UCBJY

Psorilax:Offerte |le creme solari avene sono adatte in caso di psoriasi

0

Psorilax: prezzo, funziona, recensioni, opinioni, come si usa

Jeffrey Crowley, MD

Jeffrey Crowley

La sicurezza e l'efficacia di Ilumya sono state mantenute dopo 4 anni di trattamento tra i pazienti con psoriasi a placche arruolati nello studio in aperto reSURFACE1, secondo i dati presentati al Congresso dell'Accademia Europea di Dermatologia e Venereologia.

“Qui abbiamo oltre 144 settimane di dati, ovvero dopo 52 settimane di una sperimentazione iniziale, quindi in totale abbiamo 4 anni di dati a lungo termine”, autore dello studio Jeffrey Crowley, MD, di Bakersfield Dermatology in California, ha dichiarato a Healio Dermatology. “I pazienti hanno mantenuto una risposta ad alti livelli, sia che si trattasse di PASI 100, 90 o 75, i pazienti hanno mantenuto tale efficacia. Non c'è stata alcuna svolta nella malattia tra il dosaggio, che può essere visto con alcuni altri agenti. “

Sicurezza a lungo termine, efficacia

L'analisi ha incluso 506 pazienti che sono rimasti in trattamento con Ilumya (tildrakizumab-asmn, Sun Pharma) 100 mg o 200 mg durante l'estensione in aperto dello studio reSURFACE1. Gli endpoint di efficacia includevano la percentuale di pazienti che avevano raggiunto l'Area di Psoriasi e l'indice di gravità (PASI) 75, PASI 90 e PASI 100 ad ogni visita nello studio di estensione; e percentuale di pazienti con risposta Physician Global Assessment (PGA) – “chiara” o “minima” con una riduzione di almeno due gradi rispetto al basale, secondo Crowley e colleghi.

Di quelli nel gruppo 100 mg (n = 239), a 64 settimane, l'87% ha raggiunto la PASI 75, il 54% ha raggiunto la PASI 90 e il 31% ha raggiunto la PASI 100. In questo gruppo di dose, i risultati erano simili a 208 settimane: 82% raggiunto PASI 75, 56% raggiunto PASI 90 e 28% raggiunto PASI 100.

Tra quelli del gruppo 200 mg (n = 267), a 64 settimane, l'82% ha raggiunto la PASI 75, il 52% ha raggiunto la PASI 90 e il 27% ha raggiunto la PASI 100. I risultati a 208 settimane erano quasi identici: l'82% ha raggiunto la PASI 75, 55 % raggiunto PASI 90 e 27% raggiunto PASI 100.

Le risposte di PGA sono state anche favorevoli tra i pazienti del gruppo 100 mg (65% a 64 settimane e 58% a 208 settimane) e 200 mg (63% a 64 settimane e 60% alla settimana 208).

Il 22% dei pazienti arruolati nello studio di estensione (n = 525) ha sospeso: l'8% a causa della sospensione del paziente, il 5% a causa di eventi avversi singolari e il 4% a causa della perdita al follow-up. Crowley e colleghi non hanno riportato differenze significative negli eventi avversi tra i gruppi di dose di tildrakizumab e il verificarsi di eventi prespecificati è stato relativamente basso a meno di 1,4 per 100 persone-anno.

“Il profilo di sicurezza qui è abbastanza pulito”, ha detto Crowley. “Il meccanismo d'azione qui con interleuchina-23 è diverso da quello che abbiamo usato con agenti anti-TNF e anti-IL-17, con quei farmaci che è necessario mantenere alti livelli sierici del farmaco per mantenere l'effetto. Quando inizi a perdere i livelli sierici associati a una perdita di effetto, hai bisogno di un dosaggio più frequente per quei meccanismi per mantenere i pazienti. Qui, hai un farmaco che viene dosato ogni 3 mesi, in cui non hai bisogno di quei livelli sierici elevati di farmaco “.

Sfondo acceso reSURFACE1

Lo studio in tre parti, randomizzato, in doppio cieco, controllato con placebo ha incluso pazienti di età pari o superiore a 18 anni con psoriasi a placche cronica, da moderata a grave. Nella prima parte, i pazienti sono stati assegnati in modo casuale a 100 mg o 200 mg di tildrakizumab o placebo sottocutaneo alle settimane 0 e 4. Durante la seconda parte, i pazienti assegnati al placebo nella prima parte sono stati assegnati in modo casuale al farmaco in studio a 100 mg o 200 mg a settimane 12 e 16 e successivamente ogni 12 settimane. I pazienti ai quali è stato assegnato tildrakizumab nella prima parte hanno continuato la dose del farmaco in studio alla settimana 16 e ogni 12 settimane. Nella terza parte, i pazienti assegnati al farmaco in studio nella prima parte sono stati assegnati in modo casuale in base alla risposta al trattamento misurata dai punteggi PASI:

  • responder parziali su 200 mg: continuare la dose attuale;
  • responder parziali su 100 mg: assegnati casualmente a 100 mg o 200 mg di tildrakizumab;
  • responder in entrambe le dosi: continuare la dose iniziale o il placebo; e
  • responder assegnato al placebo: ritirato con la dose iniziale del farmaco in studio alla ricaduta, a 4 settimane e ogni 12 settimane.

La risposta parziale è stata definita come un miglioramento dal 50% al 74% nella risposta PASI e la risposta è stata definita come un miglioramento del 75% o maggiore nella risposta PASI.

Lo studio di estensione è iniziato alla fine dello studio di base di 64 settimane e ha incluso pazienti con un miglioramento del 50% o superiore del punteggio PASI. Durante l'estensione, ogni 12 settimane, i pazienti hanno ricevuto la stessa dose di tildrakizumab alla fine dello studio di base.

Sulla base di questi dati e risultati di reSURFACE2, tildrakizumab ha ricevuto l'approvazione della FDA per il trattamento della psoriasi a placche da moderata a grave negli adulti nella primavera del 2018.

Inoltre, i dati di un'analisi post hoc degli studi reSURFACE pubblicati in Diario dell'American Academy of Dermatology questo autunno ha dimostrato che la sindrome metabolica non influenza l'efficacia, la sicurezza o la sopravvivenza del farmaco di tildrakizumab.

Sun Pharmaceuticals sta attualmente conducendo studi di fase 2 di tildrakizumab per l'artrite psoriasica, studi di fase 3 di tildrakizumab per il trattamento della psoriasi delle unghie e del cuoio capelluto e uno studio sulla qualità della vita nel mondo reale in pazienti con psoriasi a placche da moderata a grave.

“Il percorso genetico dell'IL-23 è incluso in diverse aree di malattie autoimmuni. Ci impegniamo a far progredire la scienza in altri stati patologici in cui il percorso IL-23 potrebbe svolgere un ruolo e continueremo a guidare la ricerca esplorativa e lo sviluppo clinico di Ilumya in condizioni al di là della psoriasi a placche “, ha affermato un portavoce di Sun Pharmaceuticals. – di Stacey L. Adams e Abigail Sutton

Riferimento:

Crowley J, et al. Efficacia e sicurezza del tildrakizumab a lungo termine per la psoriasi a placche: risultati a 4 anni da reSURFACE1. Presentato a: 28th European Academy of Dermatology and Venereology Congress; 9-13 ottobre 2019; Madrid.

DivulgazioneS: Crowley riferisce di aver ricevuto ricerche e finanziamenti da AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen, MC2 Therapeutics, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB e Verrica Pharmaceuticals; è stato consulente di AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Novartis, Sun Pharmaceutical Industries e UCB. Ha anche lavorato nell'ufficio di relatori per AbbVie, Janssen, Eli Lilly, Novartis, Regeneron, Sanofi e UCB. Si prega di consultare il poster per tutte le informazioni finanziarie pertinenti di tutti gli altri autori.

Jeffrey Crowley, MD

Jeffrey Crowley

La sicurezza e l'efficacia di Ilumya sono state mantenute dopo 4 anni di trattamento tra i pazienti con psoriasi a placche arruolati nello studio in aperto reSURFACE1, secondo i dati presentati al Congresso dell'Accademia Europea di Dermatologia e Venereologia.

“Qui abbiamo oltre 144 settimane di dati, ovvero dopo 52 settimane di una sperimentazione iniziale, quindi in totale abbiamo 4 anni di dati a lungo termine”, autore dello studio Jeffrey Crowley, MD, di Bakersfield Dermatology in California, ha dichiarato a Healio Dermatology. “I pazienti hanno mantenuto una risposta ad alti livelli, sia che si trattasse di PASI 100, 90 o 75, i pazienti hanno mantenuto tale efficacia. Non c'è stata alcuna svolta nella malattia tra il dosaggio, che può essere visto con alcuni altri agenti. “

Sicurezza a lungo termine, efficacia

L'analisi ha incluso 506 pazienti che sono rimasti in trattamento con Ilumya (tildrakizumab-asmn, Sun Pharma) 100 mg o 200 mg durante l'estensione in aperto dello studio reSURFACE1. Gli endpoint di efficacia includevano la percentuale di pazienti che avevano raggiunto l'Area di Psoriasi e l'indice di gravità (PASI) 75, PASI 90 e PASI 100 ad ogni visita nello studio di estensione; e percentuale di pazienti con risposta Physician Global Assessment (PGA) – “chiara” o “minima” con una riduzione di almeno due gradi rispetto al basale, secondo Crowley e colleghi.

Di quelli nel gruppo 100 mg (n = 239), a 64 settimane, l'87% ha raggiunto la PASI 75, il 54% ha raggiunto la PASI 90 e il 31% ha raggiunto la PASI 100. In questo gruppo di dose, i risultati erano simili a 208 settimane: 82% raggiunto PASI 75, 56% raggiunto PASI 90 e 28% raggiunto PASI 100.

Tra quelli del gruppo 200 mg (n = 267), a 64 settimane, l'82% ha raggiunto la PASI 75, il 52% ha raggiunto la PASI 90 e il 27% ha raggiunto la PASI 100. I risultati a 208 settimane erano quasi identici: l'82% ha raggiunto la PASI 75, 55 % raggiunto PASI 90 e 27% raggiunto PASI 100.

Le risposte di PGA sono state anche favorevoli tra i pazienti del gruppo 100 mg (65% a 64 settimane e 58% a 208 settimane) e 200 mg (63% a 64 settimane e 60% alla settimana 208).

Il 22% dei pazienti arruolati nello studio di estensione (n = 525) ha sospeso: l'8% a causa della sospensione del paziente, il 5% a causa di eventi avversi singolari e il 4% a causa della perdita al follow-up. Crowley e colleghi non hanno riportato differenze significative negli eventi avversi tra i gruppi di dose di tildrakizumab e il verificarsi di eventi prespecificati è stato relativamente basso a meno di 1,4 per 100 persone-anno.

“Il profilo di sicurezza qui è abbastanza pulito”, ha detto Crowley. “Il meccanismo d'azione qui con interleuchina-23 è diverso da quello che abbiamo usato con agenti anti-TNF e anti-IL-17, con quei farmaci che è necessario mantenere alti livelli sierici del farmaco per mantenere l'effetto. Quando inizi a perdere i livelli sierici associati a una perdita di effetto, hai bisogno di un dosaggio più frequente per quei meccanismi per mantenere i pazienti. Qui, hai un farmaco che viene dosato ogni 3 mesi, in cui non hai bisogno di quei livelli sierici elevati di farmaco “.

Sfondo acceso reSURFACE1

Lo studio in tre parti, randomizzato, in doppio cieco, controllato con placebo ha incluso pazienti di età pari o superiore a 18 anni con psoriasi a placche cronica, da moderata a grave. Nella prima parte, i pazienti sono stati assegnati in modo casuale a 100 mg o 200 mg di tildrakizumab o placebo sottocutaneo alle settimane 0 e 4. Durante la seconda parte, i pazienti assegnati al placebo nella prima parte sono stati assegnati in modo casuale al farmaco in studio a 100 mg o 200 mg a settimane 12 e 16 e successivamente ogni 12 settimane. I pazienti ai quali è stato assegnato tildrakizumab nella prima parte hanno continuato la dose del farmaco in studio alla settimana 16 e ogni 12 settimane. Nella terza parte, i pazienti assegnati al farmaco in studio nella prima parte sono stati assegnati in modo casuale in base alla risposta al trattamento misurata dai punteggi PASI:

  • responder parziali su 200 mg: continuare la dose attuale;
  • responder parziali su 100 mg: assegnati casualmente a 100 mg o 200 mg di tildrakizumab;
  • responder in entrambe le dosi: continuare la dose iniziale o il placebo; e
  • responder assegnato al placebo: ritirato con la dose iniziale del farmaco in studio alla ricaduta, a 4 settimane e ogni 12 settimane.

La risposta parziale è stata definita come un miglioramento dal 50% al 74% nella risposta PASI e la risposta è stata definita come un miglioramento del 75% o maggiore nella risposta PASI.

INTERRUZIONE DI PAGINA

Lo studio di estensione è iniziato alla fine dello studio di base di 64 settimane e ha incluso pazienti con un miglioramento del 50% o superiore del punteggio PASI. Durante l'estensione, ogni 12 settimane, i pazienti hanno ricevuto la stessa dose di tildrakizumab alla fine dello studio di base.

Sulla base di questi dati e risultati di reSURFACE2, tildrakizumab ha ricevuto l'approvazione della FDA per il trattamento della psoriasi a placche da moderata a grave negli adulti nella primavera del 2018.

Inoltre, i dati di un'analisi post hoc degli studi reSURFACE pubblicati in Diario dell'American Academy of Dermatology questo autunno ha dimostrato che la sindrome metabolica non influenza l'efficacia, la sicurezza o la sopravvivenza del farmaco di tildrakizumab.

Sun Pharmaceuticals sta attualmente conducendo studi di fase 2 di tildrakizumab per l'artrite psoriasica, studi di fase 3 di tildrakizumab per il trattamento della psoriasi delle unghie e del cuoio capelluto e uno studio sulla qualità della vita nel mondo reale in pazienti con psoriasi a placche da moderata a grave.

“Il percorso genetico dell'IL-23 è incluso in diverse aree di malattie autoimmuni. Ci impegniamo a far progredire la scienza in altri stati patologici in cui il percorso IL-23 potrebbe svolgere un ruolo e continueremo a guidare la ricerca esplorativa e lo sviluppo clinico di Ilumya in condizioni al di là della psoriasi a placche “, ha affermato un portavoce di Sun Pharmaceuticals. – di Stacey L. Adams e Abigail Sutton

Riferimento:

Crowley J, et al. Efficacia e sicurezza del tildrakizumab a lungo termine per la psoriasi a placche: risultati a 4 anni da reSURFACE1. Presentato a: 28th European Academy of Dermatology and Venereology Congress; 9-13 ottobre 2019; Madrid.

DivulgazioneS: Crowley riferisce di aver ricevuto ricerche e finanziamenti da AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen, MC2 Therapeutics, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB e Verrica Pharmaceuticals; è stato consulente di AbbVie, Amgen, Celgene, Dermira, Eli Lilly, Novartis, Sun Pharmaceutical Industries e UCB. Ha anche lavorato nell'ufficio di relatori per AbbVie, Janssen, Eli Lilly, Novartis, Regeneron, Sanofi e UCB. Si prega di consultare il poster per tutte le informazioni finanziarie pertinenti di tutti gli altri autori.

Psorilax:Modi per |crema sali mar morto psoriasi

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Psorilax: prezzo, funziona, recensioni, opinioni, dove si compra

La psoriasi è una condizione che colpisce circa il 2% della popolazione britannica.

Colpisce la pelle e tende a far apparire chiazze rosse, traballanti e croccanti.

Per questo motivo, i pazienti avvertiranno spesso irritazione su cuoio capelluto, gomiti, ginocchia e parte bassa della schiena.

Poiché non esiste una cura per la psoriasi, molti cercano rimedi economici che possano alleviare questi sintomi.

E a quanto pare, questo shampoo economico è un salvatore per molti che hanno la condizione della pelle.

Lo shampoo terapeutico T / Gel di Neutrogena viene venduto al dettaglio per circa £ 7.

Il lavaggio dei capelli contiene estratto di catrame di carbone solubilizzato neutro, che si dice per aiutare quelli con psoriasi.

Per risultati ottimali, i creatori di prodotti consigliano di utilizzare il prodotto due o tre volte alla settimana.

La formula ha dimostrato clinicamente di eliminare la forfora, che dovrebbe aiutare a prevenire il prurito.

È adatto a persone di età superiore ai 12 anni e può essere ritirato da Amazon o Boots.



Lo shampoo economico può essere ritirato su Amazon o su Boots

Su Amazon, il prodotto ha attirato recensioni entusiastiche.

Più di 932 clienti hanno espresso il loro verdetto sullo shampoo, che ha un punteggio di 4.5 / 5 sul sito web.

Centinaia di persone hanno anche dedicato del tempo a lasciare un commento, molti hanno affermato di aver visto risultati positivi.

Un recensore ne è uscito: “Prima di usare lo shampoo, avevo una grave psoriasi sul cuoio capelluto, al punto da perdere rapidamente i capelli a causa di graffiarmi e cercare di rimuovere i fiocchi.

“Avevo provato diversi shampoo che avrebbero dovuto funzionare, ma dopo un po 'anche loro sarebbero diventati inefficaci.

“Questo shampoo non solo mi ha salvato il cuoio capelluto e ha assicurato che la mia psoriasi scomparisse per sempre, purché lo usi ogni volta che mi lavo i capelli.”

Un altro cliente felice ha detto: “Ho provato di tutto per curare la mia psoriasi e questa è l'unica cosa che ha funzionato. Cambio vita!”

Un terzo ha aggiunto: “Ho comprato questo come era raccomandato per la psoriasi e soffrivo di un cuoio capelluto estremamente pruriginoso e traballante, e nessun altro shampoo antiforfora / psoriasi mi stava aiutando.

“Dopo averlo usato per un paio di settimane, ho già visto un enorme miglioramento – niente più prurito e solo una piccola quantità normale di scaglie … lo consiglio vivamente.”

Mentre lo shampoo funziona per centinaia di persone affette da psoriasi, potrebbe non funzionare per tutti.

Se sei preoccupato per la psoriasi, è meglio chiedere il parere del tuo medico di famiglia.

Per ulteriori informazioni, visitare il sito Web NHS.

Psorilax:sconto |crema all’ozono per psoriasi

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Psorilax: prezzo, funziona, recensioni, opinioni, dove si compra

MUMBAI, India e PRINCETON, N.J., 9 ottobre 2019 / PRNewswire / – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” comprese le sue filiali e / o società associate) ha annunciato oggi che una delle sue le filiali di proprietà hanno presentato dati di follow-up a lungo termine di ILUMYA® (tildrakizumab-asmn) Fase 3 reSURFACE 1 e 2 prove a 28esimo Congresso dell'Accademia Europea di Dermatologia e Venereologia (EADV) a Madrid, Spagna.

I dati hanno mostrato che i tassi di risposta significativi osservati nelle prime 52 e 64 settimane, rispettivamente, sono stati mantenuti nell'arco di quattro anni per le persone con psoriasi a placche da moderata a grave, con oltre la metà dei partecipanti che hanno raggiunto almeno il 90 percento di clearance cutanea (psoriasi Area Sensitivity Index (PASI) 90) e non sono stati registrati nuovi problemi di sicurezza.1,2 Ulteriori analisi di studio hanno dimostrato che la clearance cutanea dal 75 al 100 percento ottenuta con il trattamento ILUMYA nell'arco di tre anni è stata mantenuta ugualmente nelle persone con e senza sindrome metabolica,3,4 una condizione comune nelle persone con psoriasi.5

Clicca per Tweet #NEWS: @SunPharma_Live presenta dati a lungo termine che mostrano una risposta significativa alla clearance della pelle mantenuta nelle persone con psoriasi a placche da moderata a grave per quattro anni a # EADV2019. Leggi di più: https://bit.ly/2F4CEoo

“La psoriasi è una condizione individualizzata e può essere una sfida per i medici prescrivere un medicinale efficace nel tempo, soprattutto per i pazienti con patologie comorbose come la sindrome metabolica” Jeffrey Crowley, M.D., Bakersfield Dermatology, Bakersfield, California. “Questi dati forniscono la sicurezza che ILUMYA può aiutare i pazienti con psoriasi a placche da moderata a grave, indipendentemente dalla sindrome metabolica, a raggiungere e mantenere una significativa clearance della pelle a lungo termine.”

I partecipanti idonei agli studi di Fase 3 di reSURFACE 1 e 2 di ILUMYA che sono rimasti in trattamento per gli studi di estensione in aperto hanno ricevuto ILUMYA per un totale di 208 settimane (reSURFACE 1) e 200 settimane (reSURFACE 2).1,2 Dopo quattro anni, il trattamento con ILUMYA ha portato a significativi e duraturi miglioramenti osservati nei punteggi PASI e Physician Global Assessment (PGA) – misure chiave della gravità della malattia.1,2

  • ILUMYA 100 mg (reSURFACE 1, reSURFACE 2):
    • PASI 75: 82 percento, 89 percento
    • PASI 90: 56 percento, 64 percento
    • PASI 100: 28 percento, 35 percento
    • Percentuale di partecipanti con risposta PGA favorevole: 58 percento, 65 percento

ILUMYA 100 mg è stato ben tollerato, con un basso tasso di eventi avversi (eventi avversi) che erano comparabili o numericamente inferiori rispetto al placebo in base ai tassi aggiustati per l'esposizione per molte categorie di AE.1,2

I ricercatori hanno anche analizzato gli studi reSURFACE 1 e reSURFACE 2 per approfondire se l'efficacia di ILUMYA era simile nelle persone con sindrome metabolica (definita come pressione sanguigna elevata, indice di massa corporea / obesità, trigliceridi e glucosio e bassi livelli di colesterolo HDL), poiché questo co -morbidità può influire negativamente sulla risposta delle persone alla maggior parte dei farmaci biologici per la psoriasi.6 Questa analisi post hoc ha mostrato che i livelli di clearance della pelle raggiunti e sostenuti con ILUMYA 100 mg a tre anni erano comparabili nei partecipanti con e senza sindrome metabolica.3,4

  • reSURFACE 1:
    • PASI 75: 69 percento con sindrome metabolica; 71 percento senza sindrome metabolica
    • PASI 90: 42 percento con sindrome metabolica; 51 percento senza sindrome metabolica
    • PASI 100: 27 percento con sindrome metabolica; 23 percento senza sindrome metabolica
  • reSURFACE 2:
    • PASI 75: 73 percento con sindrome metabolica; 79 percento senza sindrome metabolica
    • PASI 90: 57 percento con sindrome metabolica; 60 percento senza sindrome metabolica
    • PASI 100: 34 percento con sindrome metabolica; 32 percento senza sindrome metabolica

I tassi di eventi avversi a tre anni generalmente associati alla sindrome metabolica, come infezioni, eventi cardiovascolari o complicanze del diabete, non erano diversi nei partecipanti allo studio con e senza sindrome metabolica.3,4

“La psoriasi da moderata a grave è una condizione permanente, e in Sun Pharma ci impegniamo ad aiutare le persone a trovare opzioni terapeutiche che funzionano in modo coerente nel tempo, indipendentemente da eventuali condizioni di comorbilità, per aiutare a gestire i sintomi frustranti che per così tanti gli anni fanno parte della vita di tutti i giorni “, ha detto Alan Mendelsohn, M.D., Vicepresidente associato, Dermatology Medical Affairs, Sun Pharma. “È stato dimostrato che ILUMYA fornisce una significativa clearance della pelle che inizia subito dopo l'uso iniziale e viene mantenuta per anni, con solo quattro dosi all'anno dopo due dosi iniziali, senza dimostrare alcun rischio nuovo o aumentato di eventi di sicurezza.”

Informazioni sugli studi

Studio di estensione reSURFACE 1
reSURFACE 1 era uno studio di 64 settimane in 3 parti, in doppio cieco, randomizzato, controllato, che ha valutato ILUMYA 100 mg e 200 mg alle settimane 0 e 4 e ogni 12 settimane successive negli adulti con psoriasi a placche cronica da moderata a grave . I partecipanti con almeno il 50 percento di miglioramento della PASI 50 al completamento dello studio di base che hanno ricevuto ILUMYA entro 12 settimane dalla fine dello studio di base (settimana 64) erano idonei a iscriversi allo studio di estensione e hanno continuato con la stessa dose di ILUMYA una volta ogni 12 settimane. I ricercatori hanno valutato la risposta PASI e PGA (punteggio di 0 o 1 con riduzione di grado ≥2 rispetto al basale) e i tassi di incidenza per eventi avversi prespecificati, tra cui infezioni gravi, eventi cardiovascolari e ipersensibilità correlati al farmaco.

Studio di estensione reSURFACE 2
reSURFACE 2 è stato uno studio di 52 settimane in 3 parti, in doppio cieco, randomizzato, controllato, che ha confrontato la sicurezza e l'efficacia di ILUMYA 100 mg e 200 mg con placebo ed etanercept 50 mg. Alla settimana 12, i pazienti con un miglioramento di almeno il 50 percento della PASI 50 al completamento dello studio di base su ILUMYA 100 o 200 mg erano idonei a iscriversi allo studio di estensione e continuavano con la stessa dose di ILUMYA ogni 12 settimane. Parziale e non responder a etanercept sono stati convertiti in trattamento con ILUMYA200 mg, mentre i responder (PASI ≥75) sono stati interrotti. I ricercatori hanno valutato la risposta PASI e PGA (punteggio di 0 o 1 con riduzione di grado ≥2 rispetto al basale) e i tassi di incidenza per eventi avversi prespecificati, tra cui infezioni gravi, eventi cardiovascolari e ipersensibilità correlati al farmaco.

Analisi post-hoc di reSURFACE 1 e reSURFACE 2
Sono state condotte analisi post-hoc di reSURFACE 1 e reSURFACE 2 per valutare i cambiamenti nell'efficacia di ILUMYA nelle persone con e senza sindrome metabolica, precedentemente definite come quelle che soddisfacevano i criteri del National Colesterolo Education Program-Adult Treatment Panel III (compresa la pressione sanguigna elevata , indice di massa corporea (BMI), trigliceridi e glucosio). I ricercatori hanno stratificato i risultati di efficacia – determinati dalla percentuale di pazienti con almeno PASI 75 e variazione PASI percentuale assoluta e mediana dal basale – fino alla settimana 148 in entrambi gli studi.

A proposito di ILUMYA® (Tildrakizumab-ASMN)

ILUMYA® (tildrakizumab-asmn) è un anticorpo monoclonale lgG1 / k umanizzato progettato per legarsi selettivamente alla subunità p19 dell'interleuchina-23 (IL-23) e inibire la sua interazione con il recettore IL-23, determinando l'inibizione del rilascio di pro citochine e chemochine infiammatorie. ILUMYA è indicato per il trattamento di adulti con psoriasi a placche da moderata a grave che sono candidati per terapia sistemica o fototerapia, in gli Stati Uniti. ILUMYA è stato anche approvato per la psoriasi a placche da moderata a grave Australia e con il marchio ILUMETRITM nel Europa.

INDICAZIONE E IMPORTANTI INFORMAZIONI SULLA SICUREZZA

ILUMYA (tildrakizumab-asmn) è indicato per il trattamento di adulti con psoriasi a placche da moderata a grave che sono candidati per terapia sistemica o fototerapia.

CONTROINDICAZIONI

ILUMYA è controindicato nei pazienti con una precedente reazione di ipersensibilità grave al tildrakizumab o ad uno qualsiasi degli eccipienti.

AVVERTENZE E PRECAUZIONI:

ipersensibilità: Casi di angioedema e orticaria si sono verificati in soggetti trattati con ILUMYA in studi clinici. Se si verifica una grave reazione allergica, interrompere immediatamente ILUMYA e iniziare la terapia appropriata.

infezioni: ILUMYA può aumentare il rischio di infezione. Il trattamento con ILUMYA non deve essere iniziato in pazienti con un'infezione attiva clinicamente importante fino a quando l'infezione non si risolve o non sia adeguatamente trattata. Considerare i rischi e i benefici del trattamento prima di prescrivere ILUMYA in pazienti con un'infezione cronica o con una storia di infezione ricorrente. Chiedere ai pazienti che ricevono ILUMYA di consultare un medico in caso di segni o sintomi di infezione cronica o acuta clinicamente importante. Se un paziente sviluppa un'infezione clinicamente importante o grave o non risponde alla terapia standard, monitorare attentamente e considerare l'interruzione di ILUMYA fino a quando l'infezione non si risolve.

Valutazione del pretrattamento per la tubercolosi: Valutare i pazienti per infezione da tubercolosi (TB) prima di iniziare il trattamento con ILUMYA. Non somministrare ILUMYA a pazienti con infezione da TB attiva. Iniziare il trattamento della tubercolosi latente prima di somministrare ILUMYA. Prendere in considerazione una terapia anti-TB prima dell'inizio di ILUMYA in pazienti con una storia passata di TB latente o attiva in cui non è possibile confermare un adeguato ciclo di trattamento. I pazienti che ricevono ILUMYA devono essere attentamente monitorati per segni e sintomi di tubercolosi attiva durante e dopo il trattamento.

vaccinazioni: Prima di iniziare la terapia con ILUMYA, prendere in considerazione il completamento di tutte le immunizzazioni appropriate all'età secondo le attuali linee guida per l'immunizzazione. I pazienti trattati con ILUMYA non devono ricevere vaccini vivi.

Reazioni avverse: Le reazioni avverse più comuni (≥1%) associate al trattamento con ILUMYA che sono state più frequenti rispetto al gruppo placebo sono state le infezioni delle vie respiratorie superiori, le reazioni al sito di iniezione e la diarrea.

Fare clic qui per Informazioni di prescrizione complete e Guida ai farmaci.

Informazioni sulla dermatologia solare

Sun Dermatology (la divisione dermatologica con marchio di una consociata interamente controllata di Sun Pharmaceutical Industries Inc.) è impegnata ad espandere il suo portafoglio di dermatologia per offrire agli operatori sanitari e ai pazienti in tutto il mondo più opzioni di trattamento e supporto continuo per condizioni come la placca da moderata a grave psoriasi. Sun Pharmaceutical Industries Ltd., insieme alle sue filiali, è al secondo posto nel volume delle prescrizioni di dermatologia negli Stati Uniti per IQVIA ed è la quarta più grande azienda farmaceutica di specialità generiche al mondo. Oltre a ILUMYA, Sun Dermatology comprende numerosi prodotti di marca con particolare attenzione a varie condizioni dermatologiche.

Informazioni su Sun Pharmaceutical Industries Ltd. (CIN – L24230GJ1993PLC019050)

Sun Pharma è la quarta più grande azienda farmaceutica specialistica al mondo e India migliore azienda farmaceutica. Un'azienda integrata verticalmente e un team qualificato le consentono di fornire prodotti di alta qualità, affidabili da clienti e pazienti in oltre 100 paesi in tutto il mondo, a prezzi convenienti. La sua presenza globale è supportata da impianti di produzione sparsi in 6 continenti e approvati da più agenzie di regolamentazione, insieme a una forza lavoro multiculturale che comprende oltre 50 nazionalità. Sun Pharma promuove l'eccellenza attraverso l'innovazione supportata da forti capacità di ricerca e sviluppo in più centri di ricerca e sviluppo, con investimenti pari a circa il 7% delle entrate annuali in ricerca e sviluppo. Per ulteriori informazioni, visitare www.sunpharma.com e seguirci su Twitter @SunPharma_Live.

disconoscimento

Le dichiarazioni contenute in questo “Documento” che descrivono gli obiettivi, le proiezioni, le stime, le previsioni, le previsioni, i piani o le previsioni della Società o le condizioni o gli eventi del settore possono essere “dichiarazioni previsionali” ai sensi delle leggi e dei regolamenti sui titoli applicabili. I risultati, le prestazioni o i risultati effettivi potrebbero differire materialmente da quelli espressi o impliciti.

Riferimenti

  1. Crowley J, et al. Efficacia e sicurezza del Tildrakizumab a lungo termine per la psoriasi a placche: risultati quadriennali di reSURFACE 1. Presentato al Congresso dell'Accademia europea di dermatologia e Venereologia (EADV), Ottobre 2019.
  2. Langley RG, et al. Efficacia e sicurezza del Tildrakizumab a lungo termine per la psoriasi a placche: risultati a 4 anni da reSURFACE 2. Presentato a EADV, Ottobre 2019.
  3. Lebwohl MG, et al. Efficacia di Tildrakizumab in base allo stato della sindrome metabolica nella psoriasi: analisi post hoc dei dati a 3 anni dallo studio reSURFACE 1 di fase 3. Presentato a EADV, Ottobre 2019.
  4. Gottlieb AB, et al. Efficacia di Tildrakizumab in base allo stato della sindrome metabolica nella psoriasi: analisi post-hoc dei dati a 3 anni dallo studio reSURFACE 2 di fase 3. Presentato a EADV, Ottobre 2019.
  5. Gisondi P, et al. Clin Dermatol. 2018; 36 (1): 21-28.
  6. Jacobi A, et al. Int J Dermatol. 2016; 55 (3): 296-302.

Contatti:

FONTE Sun Pharmaceutical Industries Ltd.

Link correlati

http://www.sunpharma.com

Psorilax:in vendita |lenisfera crema per psoriasi

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Il sistema immunitario umano è un'arma altamente specializzata e solitamente delicatamente bilanciata contro i patogeni che possono causare malattie e malattie. Ma a volte diventa un po 'confuso e inizia ad attaccare le stesse cellule del corpo invece di virus e batteri che sono arrivati ​​dall'esterno. Quando si verifica questa interruzione del sistema immunitario, può causare una persona a sviluppare una malattia autoimmune e ci sono molti modi in cui le condizioni autoimmuni possono farti sentire meno che fantastico.

Uno dei modi più visibili e scomodi in cui la malattia autoimmune può manifestarsi è una condizione chiamata psoriasi. La psoriasi porta a chiazze sgradevoli e molto pruriginose, a volte dolorose, di pelle secca, rossa, sollevata e irritata che si accumula in chiazze che possono apparire argentee. Queste placche possono formarsi in qualsiasi parte del corpo, ma un luogo comune è il cuoio capelluto.

Come suggerisce il nome, la psoriasi del cuoio capelluto si verifica sul cuoio capelluto. “La psoriasi del cuoio capelluto è una condizione autoimmune che provoca pelle ispessita, arrossata, screpolata sul cuoio capelluto e sulle orecchie”, afferma la dott.ssa Vanessa Johnson, dermatologa del Health First Medical Group di Viera, in Florida. Sebbene possa essere limitato solo al cuoio capelluto, in alcune persone, si estende sulla fronte e sul collo.

“In genere si presenta come una pelle pruriginosa e molto traballante sulla parte posteriore del cuoio capelluto e attorno all'attaccatura dei capelli. Può causare perdita di capelli, sanguinamento, sensazione di bruciore, prurito e squame argentee “sulla pelle del cuoio capelluto, afferma Johnson. “Per alcuni pazienti, questi sintomi sono gravi e possono causare estremo disagio, difficoltà a dormire e una diminuzione della qualità della vita.”

La psoriasi del cuoio capelluto è “causata da livelli elevati di sostanze chimiche particolari nella pelle, chiamate citochine”, afferma Johnson. Queste proteine ​​generate dal sistema immunitario “causano la formazione di nuove cellule della pelle in pochi giorni, anziché in settimane”. Questo accumulo di pelle in eccesso può essere doloroso e imbarazzante per alcune persone.

Maggiori informazioni sulla psoriasi

La pelle del cuoio capelluto che diventa secca, pruriginosa e traballante è chiamata forfora. Chiamata anche dermatite seborroica, la forfora deriva “da un'irritazione del cuoio capelluto che provoca desquamazione e prurito generalizzati”, afferma Johnson. Sebbene la sua causa esatta sia sconosciuta, potrebbe essere correlata a una reazione eccessiva del sistema immunitario a un certo tipo di fungo che si trova comunemente sul cuoio capelluto. Asciugare l'aria invernale e usare shampoo, tinture per capelli, gel per lo styling e altri prodotti personali che seccano la pelle del cuoio capelluto possono esacerbare i sintomi.

La forfora è una condizione comune e innocua che può causare imbarazzo per chi soffre, ma può spesso essere risolta passando a uno shampoo antiforfora o usando altri trattamenti da banco. D'altra parte, chiarire un caso di psoriasi del cuoio capelluto richiederà probabilmente l'assistenza di un medico e possibilmente farmaci da prescrizione.

Poiché queste due condizioni presentano entrambe una pelle secca, traballante e pruriginosa, “a volte è una dura chiamata” distinguere tra la forfora della varietà da giardino e la psoriasi del cuoio capelluto, afferma il dott. Howard Bruce Pride, dermatologo del Geisinger di Danville, in Pennsylvania. Ma spesso, può essere una questione di gravità dei sintomi. “A differenza del semplice sfaldamento, come accade con la forfora, le placche della psoriasi sono molto spesse. La scala è spessa e talvolta descritta come argentea. È un buon aggettivo che evoca l'immagine di una placca infiammata con una scala argentea. È molto più un'indicazione della psoriasi “che la forfora, dice.

Johnson aggiunge che “la psoriasi in genere ha bordi ben definiti e aree di forma ovale della pelle interessata, mentre la forfora ha bordi mal definiti senza pelle ispessita e si verifica su tutto il cuoio capelluto”.

Johnson afferma che la psoriasi del cuoio capelluto è “molto comune nei pazienti con psoriasi. I ricercatori stimano che almeno il 50% delle persone che hanno la psoriasi a placche (il tipo più comune di psoriasi), ad un certo punto avrà la psoriasi nel cuoio capelluto. ”Circa il 2% degli americani ha una qualche forma di psoriasi.

L'orgoglio dice a volte, il cuoio capelluto è l'unica parte del corpo che è influenzata dalla psoriasi “o potrebbe essere il primo luogo in cui si sviluppa la psoriasi.” La Mayo Clinic riporta che la psoriasi del cuoio capelluto è spesso il primo posto in cui la psoriasi si sviluppa nei bambini.

“Le persone che hanno altre forme di psoriasi hanno maggiori probabilità di sviluppare la psoriasi del cuoio capelluto”, afferma Johnson. Una storia familiare di psoriasi aumenta anche le possibilità di sviluppare la psoriasi del cuoio capelluto, dice.

La psoriasi del cuoio capelluto può svilupparsi in chiunque a qualsiasi età, ma le donne sembrano in qualche modo più probabilità di sviluppare la condizione. Alcune etnie sembrano avere tassi di incidenza più elevati rispetto ad altre. “In uno studio statunitense, i ricercatori hanno scoperto che il 3,6% dei bianchi, quasi il 2% degli afroamericani e l'1,6% degli ispanici aveva la psoriasi”, osserva Johnson.

Sebbene non si sappia esattamente cosa spinga qualcuno a sviluppare la psoriasi del cuoio capelluto, si ritiene che il fumo e lo stress siano due dei maggiori colpevoli. Una predisposizione genetica è anche probabilmente uno dei principali motori della psoriasi del cuoio capelluto.

Un medico in genere può diagnosticare un caso di psoriasi del cuoio capelluto facendo un'anamnesi approfondita e conducendo un esame fisico. In alcuni casi, una biopsia cutanea, in cui un piccolo campione di pelle interessata viene rimosso e inviato a un laboratorio per ulteriori test, può essere condotto per confermare una diagnosi di psoriasi.

Oggi, c'è una gamma molto più ampia di opzioni di trattamento disponibili per le persone che soffrono di psoriasi rispetto a prima. Questo grazie alle scoperte nella nostra comprensione di come si sviluppa la psoriasi e quali agenti possono aiutare a calmare un sistema immunitario iperattivo. “A seconda della gravità, il trattamento può includere una schiuma o soluzione topica, farmaci per via orale o persino un farmaco iniettabile per pazienti con psoriasi del cuoio capelluto grave”, afferma Johnson.

Per alcune persone, un cuoio capelluto pruriginoso può essere comodamente raffreddato da uno shampoo che contiene mentolo. Gli shampoo al catrame – sì, letteralmente il catrame di carbone che viene utilizzato nella costruzione di coperture e strade – possono anche essere efficaci per alleviare il prurito. “L'approccio consolidato è quello di utilizzare tar”, afferma Pride. “È in circolazione da molti, molti decenni e funziona bene. È abbastanza sicuro, ma come suggerisce il nome, è piuttosto disordinato e non c'è molto fascino estetico. Macchia, è sporco e profuma di “come un marciapiede o un tetto caldo in una giornata estiva.

Quando si tratta di trattamenti più moderni, questi tendono a rientrare in due categorie principali. Il primo sono i farmaci topici che vengono applicati direttamente sul cuoio capelluto come una crema, unguento o shampoo. Questi farmaci di solito mirano a rallentare l'eccessiva crescita cellulare e ridurre l'infiammazione e possono contenere steroidi o altri farmaci per raggiungere questi obiettivi. La National Psoriasis Foundation riferisce che i trattamenti topici comuni per la psoriasi del cuoio capelluto includono:

  • Anthralin. Conosciuto anche come dithranol, questo farmaco è una sostanza sintetica simile a un composto naturale presente nella polvere di goa dall'albero dell'arredamento che rallenta la crescita delle cellule.
  • Dovonex. Conosciuto anche come calcipotriolo o calcipotriene, questo derivato sintetico della vitamina D rallenta la crescita cellulare ed è disponibile da quasi 30 anni come trattamento a lungo termine per la psoriasi.
  • Taclonex. Questo farmaco presenta una combinazione di steroidi e calcipotriene per rallentare la crescita cellulare, ridurre l'infiammazione e il prurito e appiattire le lesioni della placca.
  • Tazorac. Chiamato anche tazarotene, questo farmaco è un derivato della vitamina A che rallenta la crescita cellulare.

I pazienti con una chioma piena possono trovare il trattamento della loro psoriasi con questi farmaci topici un po 'impegnativo, in quanto “può essere un casino per ottenere lozioni e creme nel cuoio capelluto”, afferma Pride. Pertanto, “cerchiamo di usare le medicine in forma di shampoo”, per quanto possibile quando si tratta di psoriasi del cuoio capelluto.

Per i casi più gravi o i sintomi che non migliorano con i trattamenti topici, i trattamenti sistemici che vengono assunti per via orale o sotto forma di iniezione o infusione endovenosa possono essere più efficaci. I farmaci sistemici possono includere:

  • Methotrexate. Originariamente sviluppato per trattare il cancro, il metotrexato si è dimostrato abbastanza efficace nel trattamento di una varietà di malattie reumatiche e autoimmuni, inclusa la psoriasi del cuoio capelluto.
  • Retinoidi orali Il termine retinoide si riferisce a una forma sintetica di vitamina A. Questi farmaci possono rallentare la crescita cellulare e un retinoide chiamato Soriatane, o acitretina, può essere usato per trattare la psoriasi.
  • Ciclosporina. Questo farmaco immunosoppressore che rallenta la crescita cellulare è stato originariamente sviluppato per aiutare a prevenire il rigetto di organi nei pazienti trapiantati.
  • Biologics. Questi nuovi farmaci vengono generalmente somministrati tramite iniezione o infusione endovenosa e sono immunosoppressori potenti e altamente mirati che vengono utilizzati in una varietà di disturbi autoimmuni. I biologici usati per trattare le malattie psoriasiche (psoriasi e artrite psoriasica) includono inibitori del fattore necrosi tumorale-alfa, interleuchina 12 e 23 inibitori, interleuchina 17 inibitori, inibitori delle cellule T e inibitori dell'interleuchina 23. Ogni tipo di farmaco prende di mira un componente specifico del sistema immunitario per calmare l'infiammazione e ridurre l'eccessiva crescita cellulare. I nomi commerciali di questi farmaci che potresti vedere pubblicizzati in TV includono Cosentyx, Enbrel, Humira e Taltz, tra gli altri.

L'NPF riferisce che “la perdita dei capelli è un problema comune riscontrato da coloro che soffrono di psoriasi del cuoio capelluto. Spesso questa perdita di capelli è il risultato di un danneggiamento del fusto del capello o dei follicoli piliferi e non della psoriasi stessa. Questo danno può verificarsi a seguito di sfregamento, graffi o pettinatura eccessiva e da sostanze chimiche o ingredienti in trattamenti e prodotti. ”La buona notizia è che queste perdite di capelli sono quasi sempre temporanee e ottenere un migliore controllo sui sintomi della psoriasi può aiutarti a ricrescere i capelli persi .

Oltre a seguire qualsiasi protocollo di trattamento farmacologico prescritto dal medico, Pride afferma che è anche importante considerare di apportare alcuni cambiamenti nello stile di vita che possono aiutare ad alleviare i sintomi.

Mangiare bene. Alcuni medici e pazienti ritengono che la dieta possa influire sulla gravità dei sintomi, quindi parla con il tuo medico di quali alimenti potresti voler evitare. Molte persone affermano che le verdure di belladonna, come i pomodori e gli alimenti trasformati, aggravano i sintomi. D'altro canto, l'aggiunta di determinati alimenti può aiutare. Si pensa che gli alimenti ricchi di acidi grassi omega-3, come quelli abbondanti di salmone e sardine, possano aiutare a calmare i sintomi. Altri alimenti che si pensa riducano l'infiammazione nel corpo, come la curcuma, una spezia arancione comune nella cucina indiana, possono anche migliorare i sintomi.

Evitare lo stress. “Lo stress è senza dubbio un fattore scatenante per la maggior parte delle persone con psoriasi”, afferma Pride, e questo stress può nutrirsi di se stesso. Se la tua psoriasi è innescata dallo stress, questo potrebbe farti sentire più stressato quando i sintomi si aggravano. Per aiutare a interrompere il ciclo, Pride consiglia di assicurarsi di mangiare bene e di dormire molto, poiché entrambi possono aiutarti a sentirti in un controllo migliore e meno stressato.

Perdere peso. Se stai portando un po 'di peso in più, questo potrebbe peggiorare i sintomi della psoriasi, afferma la dott.ssa Jessica Kaffenberger, assistente professore di dermatologia presso l'Ohio State University Wexner Medical Center di Columbus. “La psoriasi può migliorare con la perdita di peso. Questo perché il grasso è un tessuto metabolicamente attivo che può aumentare l'infiammazione ”in tutto il corpo. Le persone con psoriasi possono avere maggiori probabilità di essere in sovrappeso o obese e Kaffenberger afferma di consigliare queste persone sulla perdita di peso e sulla gestione del peso.

Sebbene la psoriasi del cuoio capelluto possa interessare solo una piccola parte della superficie della pelle, può avere molte conseguenze in altre parti del corpo che possono essere più difficili da vedere. Disturbi autoimmuni come la psoriasi del cuoio capelluto presentano alti livelli di infiammazione nel corpo e questo può influire negativamente su vari organi interni e sistemi corporei a parte solo la pelle. Nel tempo, può causare una serie di complicazioni, tra cui:

  • Diabete. Le persone con psoriasi hanno un aumentato rischio di sviluppare il diabete e l'infiammazione cronica associata ad entrambi i problemi può essere la connessione.
  • Malattia del cuore. L'American Academy of Dermatology riferisce che “un'infiammazione di lunga durata all'interno del corpo può influire sul cuore e sui vasi sanguigni, esponendoti a un rischio maggiore di sviluppare malattie cardiache o avere un ictus”. Cercare un trattamento adeguato può ridurre il rischio di insufficienza cardiaca.
  • Artrite. Circa il 30 percento di tutti i pazienti con psoriasi sviluppa una condizione chiamata artrite psoriasica, un tipo di artrite infiammatoria che rende le articolazioni dolorose, rigide e gonfie.
  • Malattia della tiroide. La tiroide produce e regola alcuni ormoni e questa delicata ghiandola può essere danneggiata da condizioni autoimmuni come la psoriasi del cuoio capelluto.
  • Malattie renali. L'infiammazione cronica e sistemica è dannosa per i reni e la loro funzione e la psoriasi incontrollata può portare a nefrite e altri problemi renali.
  • Depressione. Alcune persone con psoriasi lottano con il modo in cui le loro condizioni appaiono agli altri e le fanno sentire diverse.
  • Sindrome infiammatoria intestinale L'infiammazione nel tratto digestivo può portare a IBS, una condizione comune che provoca crampi, diarrea e costipazione.

Psorilax:Prezzo più basso |xerolen crema corpo psoriasi

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Psorilax: prezzo, funziona, recensioni, opinioni, composizione

Sept. 28, 2019 06:30 UTC

PRINCETON, N.J.–(BUSINESS WIRE)– Bristol-Myers Squibb Company (NYSE: BMY) today announced results of a three-year analysis of efficacy data from the Phase 3 CheckMate -238 study evaluating adjuvant use of Opdivo (nivolumab) 3 mg/kg versus Yervoy (ipilimumab) 10 mg/kg in patients with Stage III or Stage IV melanoma who were at high risk of recurrence following complete surgical resection. At three years of follow-up, Opdivo continues to demonstrate superior recurrence-free survival (RFS) compared to Yervoy, the active control, with RFS rates of 58% and 45%, respectively (HR 0.68; p<0.0001). Distant-metastasis-free survival (DMFS) also continues to be significantly longer for Opdivo, with 36-month rates of 66% and 58%, respectively (hazard ratio 0.78, p=0.044). Both RFS and DMFS benefit continue to be observed across key subgroups, including disease stages, BRAF mutation status and PD-L1 expression. No new safety data were generated as part of the 36-month analysis.

“For patients with surgically resected, advanced melanoma at high risk of recurrence, these three-year data are highly significant as they provide additional support showing the long-term benefits of adjuvant nivolumab treatment in decreasing disease recurrence,” said Jeffrey S. Weber, M.D., Ph.D., CheckMate -238 investigator and deputy director of the Perlmutter Cancer Center at New York University Langone Medical Center. “The continued separation of the curves points to the long-term potential of nivolumab to provide a durable benefit for this patient population.”

Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb, said, “In this study of resected Stage III and Stage IV high-risk melanoma patients, Opdivo continues to demonstrate sustained long-term improvements in the prevention of disease recurrence over Yervoy, the active control.”

Data from this analysis will be featured at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain (Saturday, September 28 from 8:30-10:15 AM CEST).

About CheckMate -238

CheckMate -238 is an ongoing Phase 3, randomized double-blind study of Opdivo versus Yervoy in patients who have undergone complete resection of Stage IIIb/c or Stage IV melanoma. The trial randomized 906 patients to receive either Opdivo 3 mg/kg intravenously every two weeks or Yervoy 10 mg/kg IV every three weeks for four doses and then every 12 weeks until documented disease progression or unacceptable toxicity, up to a maximum treatment duration of one year. The primary endpoint is recurrence-free survival, defined as the time between randomization and the date of first recurrence or death. The secondary endpoint is overall survival.

Adjuvant Therapy in Melanoma

Melanoma is separated into five staging categories (stages 0-4) based on the in-situ feature, thickness and ulceration of the tumor, whether the cancer has spread to the lymph nodes, and how far the cancer has spread beyond lymph nodes.

Stage 3 melanoma has reached the regional lymph nodes but has not yet spread to distant lymph nodes or to other parts of the body (metastasized) and requires surgical resection of the primary tumor as well as the involved lymph nodes. Some patients may also be treated with adjuvant therapy. Despite surgical intervention, most patients experience disease recurrence and progress to metastatic disease.

Bristol-Myers Squibb: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The focus of our research is to increase quality, long-term survival for patients and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

U.S. FDA-APPROVED INDICATIONS FOR OPDIVO®

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy, and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.

Immune-Mediated Neuropathies

In a separate Phase 3 study of YERVOY 3 mg/kg, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Skin Adverse Reactions and Dermatitis

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16.6% (91/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 14% (17/119) of patients.

In a separate Phase 3 study of YERVOY 3 mg/kg, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg after 15 days of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barré syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, and myasthenic syndrome.

If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate study in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on their mechanisms of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO- or YERVOY- containing regimen and for at least 5 months after the last dose of OPDIVO.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment. Advise women to discontinue breastfeeding during treatment with YERVOY and for 3 months following the final dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most frequent serious adverse reactions reported in at least 2% of patients receiving OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusions, and dehydration. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY and in 43% of patients receiving sunitinib. The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis; in patients treated with sunitinib, they were pneumonia, pleural effusion, and dyspnea. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients (n=154). The most frequent serious adverse reactions reported in ≥2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, and pneumonia. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 032, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=245) were fatigue (45%), decreased appetite (27%), musculoskeletal pain (25%), dyspnea (22%), nausea (22%), diarrhea (21%), constipation (20%), and cough (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) vs sunitinib (n=535) were fatigue (58% vs 69%), rash (39% vs 25%), diarrhea (38% vs 58%), musculoskeletal pain (37% vs 40%), pruritus (33% vs 11%), nausea (30% vs 43%), cough (28% vs 25%), pyrexia (25% vs 17%), arthralgia (23% vs 16%), decreased appetite (21% vs 29%), dyspnea (20% vs 21%), and vomiting (20% vs 28%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough and dyspnea at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent, the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=154) were fatigue (38%), musculoskeletal pain (36%), abdominal pain (34%), pruritus (27%), diarrhea (27%), rash (26%), cough (23%), and decreased appetite (22%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%).

In a separate Phase 3 study of YERVOY 3 mg/kg, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Indications

YERVOY® (ipilimumab) is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.

Important Safety Information

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY (ipilimumab) can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Recommended Dose Modifications

Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Discontinue in patients with severe or life-threatening infusion reactions.

Endocrine: Withhold YERVOY for symptomatic endocrinopathy. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for symptomatic reactions lasting 6 weeks or longer or an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day.

Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment.

All Other Organ Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for Grade 2 reactions lasting 6 weeks or longer, an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day, and Grade 3 or 4 adverse reactions.

Immune-mediated Enterocolitis

Immune-mediated enterocolitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms. Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent). Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to ≤Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients. Consider adding anti-TNF or other immunosuppressant agents for management of immune-mediated enterocolitis unresponsive to systemic corticosteroids within 3-5 days or recurring after symptom improvement. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-5 immune-mediated enterocolitis occurred in 76 patients (16%) and Grade 2 enterocolitis occurred in 68 patients (14%). Seven (1.5%) developed intestinal perforation and 3 patients (0.6%) died as a result of complications.

Immune-mediated Hepatitis

Immune-mediated hepatitis, including fatal cases, can occur with YERVOY. Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution. Withhold YERVOY in patients with Grade 2 hepatotoxicity. Permanently discontinue YERVOY in patients with Grade 3-4 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated hepatitis occurred in 51 patients (11%) and moderate Grade 2 immune-mediated hepatitis occurred in 22 patients (5%). Liver biopsy performed in 6 patients with Grade 3-4 hepatitis showed evidence of toxic or autoimmune hepatitis.

Immune-mediated Dermatitis

Immune-mediated dermatitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated. Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically; administer topical or systemic corticosteroids if there is no improvement within 1 week. Withhold YERVOY in patients with moderate to severe signs and symptoms. Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated dermatitis occurred in 19 patients (4%). There were 99 patients (21%) with moderate Grade 2 dermatitis.

Immune-mediated Neuropathies

Immune-mediated neuropathies, including fatal cases, can occur with YERVOY. Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities). Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities), such as Guillain-Barré-like syndromes. Institute medical intervention as appropriate for management for severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-5 immune-mediated neuropathy occurred in 8 patients (2%); the sole fatality was due to complications of Guillain-Barré syndrome. Moderate Grade 2 immune-mediated neuropathy occurred in 1 patient (0.2%).

Immune-mediated Endocrinopathies

Immune-mediated endocrinopathies, including life-threatening cases, can occur with YERVOY. Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated. Monitor clinical chemistries, adrenocorticotropic hormone (ACTH) level, and thyroid function tests at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland. Withhold YERVOY in symptomatic patients and consider referral to an endocrinologist. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. In patients receiving YERVOY 10 mg/kg in CA184-029, Grade 3-4 immune-mediated endocrinopathies occurred in 39 patients (8%) and Grade 2 immune-mediated endocrinopathies occurred in 93 patients (20%). Of the 39 patients with Grade 3-4 immune-mediated endocrinopathies, 35 patients had hypopituitarism (associated with 1 or more secondary endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary hypothyroidism. The median time to onset of Grade 3-4 immune-mediated endocrinopathy was 2.2 months (range: 2 days-8 months). Twenty-seven (69.2%) of the 39 patients were hospitalized for immune-mediated endocrinopathies. Of the 93 patients with Grade 2 immune-mediated endocrinopathy, 74 had primary hypopituitarism (associated with 1 or more secondary endocrinopathy, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 9 had primary hypothyroidism, 3 had hyperthyroidism, 3 had thyroiditis with hypo- or hyperthyroidism, 2 had hypogonadism, 1 had both hyperthyroidism and hypopituitarism, and 1 subject developed Graves’ ophthalmopathy. The median time to onset of Grade 2 immune-mediated endocrinopathy was 2.1 months (range: 9 days-19.3 months).

Other Immune-mediated Adverse Reactions, Including Ocular Manifestations

Permanently discontinue YERVOY for clinically significant or severe immune-mediated adverse reactions. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe immune-mediated adverse reactions. Monitor patients for signs or symptoms of ocular toxicity, which may include blurred vision and reduced visual acuity. Immune-mediated ocular toxicity may be associated with retinal detachment or permanent vision loss. Administer corticosteroid eye drops for uveitis, iritis, or episcleritis. Permanently discontinue YERVOY for immune-mediated ocular disease unresponsive to local immunosuppressive therapy. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss. Fatal or serious graft-versus-host disease (GVHD) can occur in patients who receive a CTLA-4 receptor blocking antibody after allogeneic hematopoietic stem cell transplantation (HSCT). Follow patients closely for evidence of GVHD and intervene promptly. Consider the benefit versus risks of treatment with a CTLA-4 receptor blocking antibody after allogeneic HSCT. In CA184-029, the following clinically significant immune-mediated adverse reactions were seen in <1% of YERVOY-treated patients unless specified: cytopenias, eosinophilia (2.1%), pancreatitis (1.3%), meningitis, pneumonitis, sarcoidosis, pericarditis, uveitis, and fatal myocarditis. Across 21 dose-ranging trials administering YERVOY at doses of 0.1 to 20 mg/kg (n=2478), the following likely immune-mediated adverse reactions were also reported with <1% incidence unless specified: angiopathy, temporal arteritis, vasculitis, polymyalgia rheumatica, conjunctivitis, blepharitis, episcleritis, scleritis, iritis, leukocytoclastic vasculitis, erythema multiforme, psoriasis, arthritis, autoimmune thyroiditis, neurosensory hypoacusis, autoimmune central neuropathy (encephalitis), myositis, polymyositis, ocular myositis, cytopenias (2.5%), and nephritis.

Embryo-fetal Toxicity

Based on its mechanism of action, YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with a YERVOY-containing regimen and for 3 months after the last dose of YERVOY.

Lactation

It is not known whether YERVOY is secreted in human milk. Advise women to discontinue breastfeeding during treatment with YERVOY and for 3 months following the final dose.

Common Adverse Reactions

The most common adverse reactions (≥5%) in patients who received YERVOY at 10 mg/kg were rash (50%), diarrhea (49%), fatigue (46%), pruritus (45%), headache (33%), weight loss (32%), nausea (25%), pyrexia (18%), colitis (16%), decreased appetite (14%), vomiting (13%), and insomnia (10%)

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

Checkmate Trials and Patient Populations

Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 032–small cell lung cancer; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma; Checkmate 238–adjuvant treatment of melanoma.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol-Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that Opdivo may not achieve its primary study endpoints or receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol-Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2018, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol-Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Psorilax:Uso |crema corpo proxera psomed 20 per curare la psoriasi

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Psorilax: prezzo, funziona, recensioni, opinioni, ingredienti

C'è una battuta tra i dottori che la dermatologia – il trattamento delle condizioni della pelle – sia il lavoro più semplice in medicina. “I pazienti non muoiono mai, non ti chiamano mai di notte e non migliorano mai”, o così si dice.

Per tradurre: i problemi della pelle sono non gravi e soprattutto cosmetici – quindi non ci sono mai emergenze. E poiché molte delle condizioni che trattiamo sono per tutta la vita e incurabili, è – è implicito – particolarmente redditizio se fai pratica privata.

Avendo lavorato come dermatologo per oltre due decenni, vorrei dire che queste sono idee sbagliate che mi irritano a morte. E a chiunque possa credere a queste cose, direi, chiaramente non hai mai incontrato un paziente con psoriasi.

I lettori potrebbero ricordare Philip Marlow, il personaggio principale della serie TV di Dennis Potter The Singing Detective. Il personaggio era un malato di psoriasi, interpretato da Michael Gambon, che era stato consegnato in un letto d'ospedale, coperto di piaghe angosciose e tormentato dal dolore.

Un caso così grave è raro. Ma oggi, oltre un milione di britannici sono colpiti in una certa misura. In quelli con psoriasi, le cellule della pelle si moltiplicano dieci volte più velocemente della frequenza normale. Le cellule in eccesso si accumulano sulla superficie della pelle, formando placche rosse, sollevate e squamose che possono essere dolorose.

I pazienti soffrono di sintomi per settimane o mesi, che possono risolversi con il trattamento, per poi tornare più tardi. E non è “solo un'eruzione cutanea”: alcune forme della condizione sono associate a un tipo doloroso di artrite.

Coloro che hanno visto The Singing Detective possono ricordare scene particolarmente scomode in cui l'infermiera di Marlow, interpretata da Joanne Whalley, ha dovuto spalmarsi il corpo in unguento per alleviare il disagio

Coloro che hanno visto The Singing Detective possono ricordare scene particolarmente scomode in cui l'infermiera di Marlow, interpretata da Joanne Whalley, ha dovuto spalmarsi il corpo in unguento per alleviare il disagio

Esistono legami noti con il colesterolo alto, le malattie cardiache, il diabete, le condizioni intestinali e le malattie del fegato e, in media, chi soffre di psoriasi vive quattro anni in meno rispetto alle persone sane.

Per dirlo in prospettiva, potresti vedere una durata della vita simile abbreviata nei bevitori eccessivi. E poiché è così visibile, la malattia può innescare ansia paralizzante, depressione e insonnia. Può distruggere le relazioni e le prospettive di lavoro – un quinto dei pazienti sarà in congedo per malattia a lungo termine ad un certo punto.

Gli studi hanno dimostrato che circa un malato su 15 ha contemplato il suicidio e alcuni si tolgono la vita. Quindi dire che i pazienti “non muoiono mai” per la malattia non è vero. E sì, è incurabile. Ma ciò non significa che “non miglioreranno mai”. C'è molto che possiamo fare per aiutare.

Perdere peso può tenere a bada i sintomi

Per alcuni dei miei pazienti affetti da psoriasi, le loro condizioni della pelle sono solo una delle tante malattie. La malattia può andare di pari passo con l'obesità, il diabete e l'ipertensione, un gruppo pericoloso di problemi a volte indicato come sindrome metabolica.

In uno studio del 2013 su oltre 70.000 donne, quelle che erano obese avevano quasi il doppio delle probabilità rispetto a quelle di peso sano di soffrire di psoriasi. Gli scienziati non sono sicuri dell'esatta natura di questa relazione. Ma si pensa che sia correlato a processi infiammatori, comuni alla sindrome metabolica e alla psoriasi.

Le cellule adipose hanno una serie di funzioni, incluso il rilascio di messaggeri chimici che aiutano a regolare il sistema immunitario. Più grasso abbiamo, più alti sono i livelli di questi prodotti chimici. Nel tempo, ciò può causare problemi: infiammazione a basso livello dei principali organi e vasi sanguigni, aumentando il rischio di una serie di malattie.

I processi infiammatori si verificano anche nella psoriasi e contribuiscono alla rapida crescita delle cellule della pelle. Gli studi dimostrano che la perdita di peso può aiutare a tenere a bada i sintomi della psoriasi per alcune persone e consiglio a tutti i miei pazienti di mantenere un peso sano. È solo un semplice passo, insieme ai farmaci e ad altre scelte di vita sane, che potrebbero aiutarli a ottenere una sospensione della loro condizione.

A partire dalla scorsa settimana, la psoriasi ha trovato un nuovo volto e corpo nella realtà TV star Kim Kardashian-West

A partire dalla scorsa settimana, la psoriasi ha trovato un nuovo volto e corpo nella realtà TV star Kim Kardashian-West

A partire dalla scorsa settimana, la psoriasi ha trovato un nuovo volto – e corpo – nella star della TV Kim Kardashian-West

Volto della malattia … Kim Kardashian

A partire dalla scorsa settimana, la psoriasi ha trovato un nuovo volto – e corpo – nella star della TV Kim Kardashian-West. Famosa per apparire normalmente impeccabile, la 38enne ha pubblicato immagini che mostrano l'entità dei suoi problemi di pelle.

“Scabbia” rosse arrabbiate e squamose coprivano gran parte della sua parte inferiore della gamba, allungandosi da sopra la sua caviglia a poco meno della sua coscia. Un altro selfie ha mostrato una collezione di macchie cremisi sul suo viso solitamente perfetto – tutti i classici sintomi della psoriasi.

La madre di quattro figli aveva scritto un resoconto della sua malattia e aveva condiviso un messaggio allegro, che era “a suo agio” con esso. Ma arrivare a questo punto può essere difficile.

La nostra pelle è ciò che il mondo vede. E quando c'è qualcosa di visibilmente sbagliato in questo, la gente se ne accorge. Il pregiudizio è diffuso: non puoi “catturare” la psoriasi o trasmetterla, ma i pazienti mi raccontano storie strazianti di essere cacciati da piscine o palestre e persino rifiutato il servizio nei negozi, nel timore di “diffondere la malattia”.

Famosa per apparire normalmente impeccabile, la 38enne ha pubblicato immagini che mostrano l'entità dei suoi problemi di pelle

Famosa per apparire normalmente impeccabile, la 38enne ha pubblicato immagini che mostrano l'entità dei suoi problemi di pelle

Fortunatamente, poiché il numero interessato sembra essere aumentato, anche la comprensione dell'impatto psicologico della malattia è aumentata. Oggi c'è una nuova specialità: la psicodermologia, una fusione di dermatologia e psicologia.

Abbiamo uno psicodermatologo devoto nella mia clinica. È nota per aver iniziato le sue consultazioni chiedendo: “Dimmi cosa stava succedendo nella tua vita quando sono iniziati i problemi della pelle?”

Gli studi hanno collegato lo stress e persino il trauma infantile alla psoriasi. Tuttavia, mentre lo stress può causare una riacutizzazione o innescare l'insorgenza della psoriasi, c'è sempre una ragione genetica alla base della malattia.

Una cosa è certa: la mentalità di un paziente è parte integrante di quanto bene affrontano la malattia e di quanto gravemente li colpisca.

Ai pazienti vengono spesso prescritti trattamenti che trattano i sintomi della pelle. Ma idealmente, questo dovrebbe essere combinato con una qualche forma di terapia del linguaggio o consapevolezza. Nei casi più gravi, un ciclo di farmaci anti-ansia o antidepressivi può anche fornire un sollievo necessario dai sentimenti di umore basso innescati dalla condizione.

Problemi nelle aree più intime

Un aspetto poco discusso della psoriasi è il modo in cui colpisce le aree intime. Per una mia paziente, l'agonia della sua condizione di pelle colpisce solo quando va in bagno. Invece di chiazze di pelle ispessita e traballante sugli arti, ha chiazze rosse e sensibili e crepe tra i glutei.

Alcuni pazienti che vengono in clinica scoprono che le loro vite sentimentali sono gravemente colpite dai loro sintomi.

Mancano di fiducia e possono davvero lottare per essere intimi con i loro partner.

Un altro problema relativamente sconosciuto è la disfunzione erettile. Chi soffre di psoriasi ha maggiori probabilità di incontrare questo problema rispetto agli uomini sani. Questo può avere una causa psicologica o fisica, ma in entrambi i casi è importante informare il medico che può indirizzarti a uno specialista.

Più in offerta ora che unguenti

Dico alla gente: non ti preoccupare, non sono contagiosa

A Lianne Hunter fu diagnosticata all'età di cinque anni

A Lianne Hunter fu diagnosticata all'età di cinque anni

Lianne Hunter, 32 anni, è un dirigente delle pubbliche relazioni di Manchester.

Dice: “Avevo 12 anni, nuotavo con la mia sorellina in una piscina locale, quando un membro dello staff mi ha chiesto di uscire.

'Avevano notato le macchie che coprivano la mia pelle e credevano che fossero contagiose. In realtà, era la psoriasi, una condizione della pelle che mi è stata diagnosticata all'età di cinque anni.

'Quando sono entrato nella mia adolescenza, i piccoli segni che si sono inizialmente sviluppati sulla mia pelle sono cresciuti e si sono diffusi ovunque.

'Erano su tutto il mio cuoio capelluto, fronte, orecchie, busto, gambe, braccia, sotto le unghie e le unghie dei piedi.

'Mi sono sentito davvero imbarazzato – è diventato così male che lo farei notare alle persone prima che potessero dire qualsiasi cosa. Direi a tutti quelli che ho incontrato: “Ciao, sono Lianne, ho la psoriasi e non è contagiosa”. Negli ultimi anni ho sofferto di affaticamento, umore basso e dolori articolari molto gravi.

'L'unica volta che i miei sintomi sono scomparsi è stato due anni fa quando ho avuto un bambino. Prima di ciò, li controllavo relativamente bene con la dieta e l'esercizio fisico. Ma a poche ore dal parto è tornato, praticamente in tutto il mio corpo.

'Al momento sto usando una crema steroidea per curare la mia pelle, ma non mi aiuta molto. Sono in una lista d'attesa per vedere il dermatologo e sperare in qualcosa di più forte.

'È bello che Kim Kardashian sia pubblica sulla sua psoriasi. Come lei, a volte mi trucco per coprire le toppe. Ma a volte no.

'Sto imparando a sentirmi a mio agio con la mia pelle. Forse in questo modo, il pregiudizio contro le persone con problemi di pelle si fermerà. “

Coloro che hanno visto The Singing Detective possono ricordare scene particolarmente scomode in cui l'infermiera di Marlow, interpretata da Joanne Whalley, ha dovuto spalmarsi il corpo in unguento per alleviare il disagio. Allora era praticamente il pilastro del trattamento. Nei casi più gravi, i pazienti potevano persino essere ricoverati in ospedale fino a quando le placche non si fossero chiarite.

Ma le cose sono andate avanti. Ora abbiamo una serie di opzioni di trattamento che sono altamente efficaci, ma trovare la terapia giusta può richiedere una certa persistenza.

Il primo punto di riferimento per la psoriasi lieve sono idratanti speciali e spesse chiamate emollienti. Aiutano la pelle a trattenere l'umidità, permettendole di guarire e vengono applicate più volte al giorno sulla zona interessata.

Se questi non funzionano da soli, possiamo offrirti creme da prescrizione insieme a loro.

Le creme corticosteroidi agiscono attenuando l'infiammazione sottostante nella psoriasi. Questo rallenta la produzione eccessiva di cellule della pelle e riduce il prurito. Le creme derivate dalla vitamina D possono essere utilizzate insieme a loro, aumentando l'effetto anti-infiammatorio. Funzionano rallentando la produzione di cellule della pelle e riducendo l'infiammazione. Le creme o gel derivati ​​dalla vitamina A sono un altro tipo di trattamento comune.

Le creme corticosteroidi non devono essere utilizzate troppo a lungo perché possono esserci effetti collaterali: nel tempo possono assottigliare la pelle e causare smagliature. Dovrebbero essere usati con cura sul viso e nelle aree intime.

Abbiamo anche nuove creme da prescrizione, note come inibitori della calcineurina. Attualmente ci sono due opzioni, unguento al tacrolimus, noto anche come Protopic, e crema al pimecrolimus, marchiato Elidel. Questi funzionano sopprimendo l'attività della risposta immunitaria nella pelle, portando alla cancellazione dei sintomi. Entrambi possono essere utilizzati a lungo termine ma non sono efficaci per tutti.

C'è anche la terapia della luce, che comporta l'esposizione della pelle ai raggi ultravioletti artificiali sotto controllo medico.

I raggi rallentano il ciclo di crescita delle cellule della pelle. Ogni sessione dura fino a pochi minuti. Sono necessarie da due a tre sessioni alla settimana, a volte per alcuni mesi, affinché funzioni. Per alcuni trattamenti, un farmaco chiamato psoralene può essere somministrato per rendere la pelle più sensibile alla luce.

Alcuni pazienti pensano che l'uso dei lettini aiuti, ma le macchine utilizzate in ospedale sono specializzate ed emettono un tipo di luce molto diverso. Consiglio vivamente di non utilizzare i lettini per la psoriasi, poiché non avranno gli stessi benefici e possono aumentare il rischio di sviluppare il cancro della pelle.

I nuovi farmaci possono cambiare la vita

Negli ultimi anni sono emersi nuovi e innovativi trattamenti farmacologici. Pillole che sopprimono le reazioni immunitarie che guidano la psoriasi, come metotrexato o ciclosporina, sono state utilizzate per molto tempo. Poi vennero i farmaci chiamati retinoidi orali. Questi si legano ai recettori della pelle, normalizzando la velocità di crescita delle cellule della pelle.

Più di recente è arrivato l'avvento dei trattamenti biologici. A differenza dei vecchi farmaci di soppressione del sistema immunitario, questi, erogati tramite un jab, dirigono la loro azione sui messaggeri chimici nella pelle specificamente responsabili dell'infiammazione.

Alcuni, incluso uno chiamato etanercept, sono anche un trattamento efficace per altre condizioni, tra cui alcuni tipi di artrite.

Queste iniezioni regolari possono cambiare la vita. Di recente un paziente è venuto nella mia clinica dopo aver eseguito il suo terzo giro di colpi. Per più di un decennio, era stato schiavo delle sue creme, lasciandolo con le mani unte. Il suo lavoro prevedeva molte scartoffie che, durante una riacutizzazione, aveva troppa paura di toccare per paura di lasciare macchie oleose.

Ora è irriconoscibile. È prospero al lavoro e pronto per una promozione. Soprattutto, al momento, è privo di psoriasi.

  • La dott.ssa Stefanie Williams è direttrice medica di Eudelo (eudelo.com), la clinica dermatologica.

Psorilax:Per le coppie |crema che ti libera da psoriasi

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Psorilax: prezzo, funziona, recensioni, opinioni, come si usa

Una donna del Tennessee ha affermato di aver quasi perso la mano a causa della contrazione di batteri che mangiavano carne dopo aver ricevuto una manicure in un salone di bellezza a Knoxville.

Jayne Sharp ha detto all'affiliata della CBS WTVF di non aver pensato a nulla quando “è stata colpita nel pollice”, ma un paio d'ore dopo aver lasciato il salone, il suo pollice ha iniziato a pulsare. Da lì, l'infezione si è intensificata.

Presto iniziò a manifestare sintomi simil-influenzali e dopo aver parlato con sua figlia che è un'infermiera registrata, decise di andare dal medico, dove un infermiere usò un pennarello per rintracciare il suo gonfiore e la rimandò a casa.

10 FOTOGRAFIE

10 strani problemi di pelle che possono segnalare una malattia

Vedi Galleria

Stai scoppiando come un matto

L'acne adulta è così comune (ecco perché — e il modo migliore per trattarla), ma quando si tratta di uno sviluppo abbastanza nuovo, presta attenzione. I cambiamenti della pelle come l'acne possono essere un segno della sindrome dell'ovaio policistico (PCOS), uno squilibrio ormonale che colpisce 10 milioni di donne in tutto il mondo. Quando il corpo di una donna produce ormoni “maschili” in eccesso chiamati androgeni, è spesso accompagnato da un aumento dell'acne. Il medico può sospettare la PCOS se si ha l'acne con periodi irregolari o acne che si infiammano poco prima del ciclo mestruale, afferma la dott.ssa Reynolds.

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Noti spuntare molte etichette della pelle

Alcune di queste escrescenze cutanee qui o là sono normali, ma numerosi tag cutanei che iniziano ad apparire potrebbero indicare il diabete di tipo 2. Sono stimolati dal fattore di crescita insulino-simile 1, una proteina coinvolta nel diabete che stimola la crescita eccessiva della pelle, afferma Rachel Reynolds, MD, dermatologa del Beth Israel Deaconess Medical Center. Altri segni di tipo 2 includono aumento della sete, lenta guarigione delle ferite e aumento della fame. Ecco alcuni sintomi più silenziosi del diabete che potresti perdere.

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Hai sviluppato una strana eruzione cutanea

Qualcosa di benigno come un nuovo detersivo per bucato o bottoni di metallo sui pantaloni può essere dietro una nuova eruzione cutanea, ma così può fare morsi. Cinque diversi tipi di malattie delle zecche causano eruzioni cutanee rivelatrici, dal centro di Lyme e STARI (malattia dell'eruzione cutanea associata alle zecche meridionali) a piccole macchie rosa che punteggiano polsi, avambracci e caviglie associati alla febbre maculata delle Montagne Rocciose. Fai attenzione a tali cambiamenti della pelle se sei stato in campeggio, facendo escursioni o trascorrendo del tempo all'aperto in aree note. Trova un segno di spunta attaccato a te? Ecco come rimuoverlo in sicurezza.

Hai una strana eruzione cutanea, parte II

L'avvio di un nuovo farmaco comporta sempre potenziali reazioni. Un grave problema: un'allergia chiamata “reazione farmacologica con eosinofilia e sintomi sistemici” o sindrome DRESS, una condizione potenzialmente pericolosa per la vita caratterizzata da un'infiammazione del fegato, del cuore e dei polmoni, afferma il dermatologo Cindy Owen in un comunicato stampa americano Accademia di Dermatologia. Ancora più confuso: questa eruzione cutanea può apparire da due a otto settimane dopo iniziare il med. Fai attenzione se hai un'eruzione cutanea accompagnata da febbre o gonfiore dei linfonodi.

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Sei così, così pruriginoso

Se hai la pelle secca, specialmente nei mesi invernali, puoi scommettere sul fatto che ti senti prurito. Ma quando una buona crema idratante non fornisce sollievo, potrebbe essere qualcosa di più serio della pelle secca. Il prurito può essere causato da alcuni tumori come la leucemia e il linfoma, nonché malattie del fegato e insufficienza renale. Se il prurito è in tutto il corpo, è grave, viene dal nulla o è così grave che stai perdendo il sonno perché sei così a disagio, parla con il tuo medico, dice il dottor Reynolds. Prurito con sudorazioni notturne, febbri e inspiegabile perdita di peso sono altri sintomi della bandiera rossa, dice. Per la corsa del mulino prurito della pelle, prova questi rimedi casalinghi.

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Ci sono dossi rossi teneri sotto la pelle

Sebbene l'intestino e la pelle possano non sembrare così connessi, lo sono: dai un'occhiata a questi 21 segreti che l'intestino sta cercando di dirti. Condizioni infiammatorie come la malattia dell'intestino irritabile (IBD) possono presentarsi sulla pelle. Noduli rossi dolorosi possono apparire sulle gambe; si sentiranno anche in profondità nella superficie della pelle, spiega il dottor Reynolds. La condizione si chiama eritema nodoso e può manifestarsi durante una riacutizzazione dei sintomi, come diarrea persistente o feci sanguinolente. Il sangue nella tua cacca può sembrare spaventoso, ma è uno di quei sintomi di salute spaventosi che possono rivelarsi innocui.

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La tua pelle è sudata e ruvida

A meno che non ti stia rilassando in una sauna o vivendo i tropici, questo potrebbe essere un segno di una tiroide iperattiva. Nelle persone che hanno ipertiroidismo, il loro metabolismo è aumentato. Questo può tradursi in caldo e arrossato (in particolare quando non c'è nessun altro nella stanza). Il medico dovrebbe interrogarti su altri sintomi che potrebbero segnalare disfunzione tiroidea, come perdita di peso o difficoltà a dormire. Ecco come sapere quando controllare i livelli della tiroide.

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La parte inferiore delle gambe è gonfia e rossa

Quando qualcuno soffre di insufficienza cardiaca congestizia, il suo cuore indebolito lotta per mantenere il sangue in movimento contro l'attrazione della gravità. Di conseguenza, il sangue può accumularsi nelle gambe, spiega il Dr. High. Vedere le linee profonde dopo aver tolto le calze è un altro segno, dice. Detto questo, l'insufficienza cardiaca congestizia ha maggiori probabilità di colpire gli anziani; se sei un giovane e hai le calze, le calze potrebbero essere troppo piccole. (Sembra divertente, ma è vero!) Cattura i primi segni di insufficienza cardiaca.

Hai dossi gialli sotto la pelle

Se osservato su articolazioni, mani, piedi e glutei, i dossi gialli possono accumularsi di grasso sotto la pelle. Chiamati xantomi, questi dossi indicano che il colesterolo o altri grassi nel sangue sono troppo alti; possono anche indicare diabete, pancreatite e persino alcuni tumori.

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Pensa prima all'ovvio

Sebbene i problemi della pelle possano essere un segno di una malattia più grave, se sellati dalla pelle secca o dal prurito, non passare allo scenario peggiore, afferma il dott. High. Se hai prurito, prova prima una crema idratante. Se hai l'orticaria, prendi un antistaminico o prova una crema all'idrocortisone. Quindi se il problema non si risolve rapidamente, potrebbe essere il momento di consultare il medico.

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NASCONDI TITOLO

MOSTRA TITOLO

“Mi aveva chiamato alle 4 in punto, mi aveva svegliato e mi aveva chiesto che aspetto avesse quella striscia ed era completamente oltre il mio gomito”, ha detto Sharp.

Da lì, è stata portata di corsa al pronto soccorso dove i dottori le hanno detto di aver contratto una rara, ma mortale infezione batterica carnivora chiamata fascite necrotizzante, ha riferito la CBS di Los Angeles.

Il CDC descrive l'infezione come “che si diffonde rapidamente nel corpo e può causare la morte” e afferma che l'uso rapido di antibiotici e la chirurgia sono fondamentali per fermarlo.

Sharp ha subito diversi interventi chirurgici a Knoxville e Nashville e ha detto che ci sono voluti mesi per sentirsi normale, anche se il suo pollice è ancora un po 'insensibile. “I medici ci hanno detto che se avessi aspettato un'altra ora, potrebbe non essere una buona situazione”, ha detto Sharp a WTVF.

“Sono solo fortunato ad essere vivo”, ha detto alla CBS.

Sharp sta attualmente perseguendo un'azione legale contro il salone.

Mentre la maggior parte dei saloni di bellezza sono sicuri, ci sono alcune cose che i clienti possono cercare per assicurarsi che un salone sia all'altezza del codice. Secondo l'American Academy of Dermatology Association, i clienti dovrebbero prima guardarsi intorno per vedere se il salone è tenuto pulito e in ordine e se i tecnici si lavano le mani o cambiano i guanti prima di ogni servizio. Possono anche chiedere al salone come vengono tenuti puliti gli strumenti – tutti gli strumenti devono essere smaltiti o disinfettati dopo ogni utilizzo – e verificare la licenza di un tecnico.

Prima di entrare nel salone, i clienti possono prendere ulteriori precauzioni ed evitare di radersi le gambe 24 ore prima di una pedicure. Eventuali piccoli tagli o ferite potrebbero essere suscettibili alle infezioni, motivo per cui i tecnici non dovrebbero mai usare una lama affilata per tagliare le cuticole o rimuovere i calli.

Se tutto sembra a posto, ma la pulizia è ancora un problema, i clienti possono anche acquistare il proprio set di strumenti per unghie da utilizzare in salone.

10 FOTOGRAFIE

10 sottili segni di malattia che possono rivelare i tuoi piedi

Vedi Galleria

Piedi asciutti e traballanti

Potrebbe essere: Problemi alla tiroide, soprattutto se la crema idratante non aiuta. Quando la ghiandola tiroidea (la ghiandola a forma di farfalla nella base del collo) si accende, non produce correttamente ormoni tiroidei, che controllano il metabolismo, la pressione sanguigna, la crescita dei tessuti e lo sviluppo del sistema scheletrico e nervoso. “I problemi alla tiroide causano grave secchezza della pelle”, afferma Marlene Reid, DPM, specialista del piede a Naperville, Illinois. “Quando vediamo screpolature sui piedi o se la crema idratante non migliora la secchezza per alcuni giorni, di solito indirizziamo i pazienti al loro medico primario per assicurarsi che le loro tiroidi siano OK.” Le unghie dei piedi fragili possono anche segnalare complicazioni alla tiroide. Non perdere questi altri 13 segni silenziosi di un problema alla tiroide.

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Dita calve

Potrebbe essere: Malattia arteriosa Se il fuzz sulle dita dei piedi scompare improvvisamente, potrebbe segnalare una cattiva circolazione del sangue causata da malattia arteriosa periferica (PAD). “I segni del PAD possono includere una ridotta crescita dei peli su piedi e caviglie, dita violacee e pelle sottile o lucente”, afferma Suzanne Fuchs, DPM, un chirurgo podologo presso il North Shore University Hospital di New York. Un accumulo di placca nelle arterie delle gambe, PAD colpisce circa 8 milioni di americani. I sintomi sono impercettibili, ma i medici possono verificare la presenza di un polso sano nel piede o individuare la PAD su una radiografia. “Se prendo una radiografia di un piede rotto e vedo un indurimento delle arterie, il 99 percento delle volte, accade la stessa cosa nei vasi sanguigni del cuore”, afferma Gary A. Pichney, DPM, un podologo chirurgo dell'Istituto per la ricostruzione del piede e della caviglia presso il Mercy Medical Center. (Questi 11 test rilevano malattie cardiache silenziose.)

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Ulcere che non guariscono

Potrebbe essere: Diabete. Livelli di glucosio incontrollati possono danneggiare i nervi e causare cattiva circolazione, quindi il sangue non raggiunge i piedi. Quando il sangue non arriva a una ferita causata, ad esempio, da scarpe irritanti, la pelle non guarisce correttamente. “Molte, molte persone con diabete vengono diagnosticate per prime a causa di problemi ai piedi”, afferma Reid. Altri segni del diabete possono includere formicolio o intorpidimento dei piedi. Chiedi al tuo medico di fare test dei livelli di zucchero nel sangue. Memorizza questi 12 consigli per la cura dei piedi che dovresti seguire in caso di diabete.

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Alluce ingrandito, doloroso

Potrebbe essere: Cosa mangiasti. Rimpinzato di vino e bistecca? Le conseguenze dolorose potrebbero essere la gotta, un tipo di artrite che di solito colpisce l'articolazione dell'alluce. (Ecco alcuni rimedi naturali per il dolore e il gonfiore.) Gli alimenti ricchi di purina, un composto chimico che si trova nelle carni rosse, nel pesce e in alcuni alcolici, possono scatenare un attacco aumentando i livelli di acido urico nel corpo. L'acido urico viene normalmente escreto attraverso l'urina, ma è sovrapprodotto o sotto-escreto in alcune persone. “Vedrai la deposizione di acido urico nell'articolazione, più comunemente l'alluce o la caviglia”, afferma Bob Baravarian, DPM, specialista in podologia del piede e della caviglia presso il Providence Saint John's Health Center di Santa Monica, California. “Il paziente si sveglierà con un'articolazione dura, rossa e gonfia. È estremamente doloroso. “Un medico può prescrivere farmaci antinfiammatori per un sollievo a breve termine e suggerire una dieta a basso contenuto di purine per la prevenzione a lungo termine. Che tu abbia la gotta o no, impara come i pediatri prevengono i problemi ai piedi quando indossano sandali.

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Minuscole linee rosse sotto l'unghia del piede

Potrebbe essere: Un'infezione al cuore. Striature rosse sotto le unghie dei piedi o delle unghie potrebbero essere i vasi sanguigni rotti noti come emorragie da scheggia. Questi si verificano quando piccoli grumi di sangue danneggiano i piccoli capillari sotto le unghie. Possono segnalare endocardite, un'infezione del rivestimento interno del cuore. Le persone che hanno una patologia cardiaca esistente, hanno ricevuto un pacemaker o che hanno un sistema immunitario cronicamente soppresso (come i pazienti oncologici che ricevono chemioterapia, pazienti affetti da HIV e pazienti diabetici) hanno un rischio maggiore di sviluppare endocardite. L'infezione può provocare insufficienza cardiaca se non trattata. Se noti emorragie da scheggia sulle unghie dei piedi o sulle unghie e non hai riscontrato alcun trauma recente all'unghia, consulta il medico per controllare la circolazione del cuore e del sangue. Scopri cos'altro dice il tuo colore naturale delle unghie sulla tua salute.

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Clubbing

Potrebbe essere: Cancro polmonare o malattie cardiache. Un altro sintomo che appare sia nelle dita dei piedi che nelle dita, il clubbing è spesso associato a cancro ai polmoni, infezione polmonare cronica, malattie cardiache o malattie intestinali. Il carcinoma polmonare e le malattie cardiache riducono la resistenza vascolare, il che significa che aumenterà il flusso sanguigno verso le piccole arterie delle unghie dei piedi e delle dita. Il tessuto si gonfia e si traduce in un aspetto “clubbed” (dita e dita più rotonde, più larghe). Sebbene i pazienti siano generalmente consapevoli di avere una malattia che sta causando il clubbing, è meglio controllare se si riscontrano anomalie. Non ignorare questi altri segni silenziosi di gravi problemi di salute.

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Unghie dei piedi snocciolate

Potrebbe essere: Psoriasi Se trovi piccoli fori, scanalature o creste nelle unghie dei piedi, potresti avere la psoriasi delle unghie. Sebbene la maggior parte delle persone che soffrono di psoriasi delle unghie abbia anche la psoriasi cutanea (una malattia autoimmune che rende la pelle irregolare e irritata), il 5 percento delle persone con psoriasi delle unghie non è interessato altrove. “Se non ti è mai stata diagnosticata la psoriasi, ma le unghie dei piedi hanno piccole fossette, dovresti farle controllare”, afferma Pichney. Altri sintomi includono macchie bianche e linee orizzontali attraverso le unghie. Per curare la psoriasi, il medico può prescrivere creme o steroidi topici da iniettare sotto l'unghia. Ulteriori informazioni sulla cura della pelle che i dermatologi raccomandano per la psoriasi.

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Chiodi a cucchiaio

Potrebbe essere: Anemia o lupus. Hai una depressione dell'unghia del piede abbastanza profonda da contenere una goccia d'acqua? Conosciute anche come koilonychias, unghie dei piedi a forma di cucchiaio o unghie possono indicare carenza di ferro, così come emocromatosi (sovrapproduzione di ferro), malattia di Raynaud (che influenza l'afflusso di sangue alle dita delle mani e dei piedi) e talvolta lupus (una malattia autoimmune in cui il sistema immunitario attacca cellule, tessuti e organi). Le unghie con il cucchiaio appaiono occasionalmente nei neonati, ma si normalizzano nei primi anni di vita. Se noti un cucchiaio, contatta il tuo medico, il quale eseguirà un esame del sangue per identificare la causa esatta. Dai un'occhiata a queste altre cose che le tue unghie rivelano della tua salute.

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Una linea retta sotto le unghie dei piedi

Potrebbe essere: Cancro della pelle. Una linea scura e verticale sotto l'unghia del piede potrebbe essere un melanoma lentigginoso acrale o un melanoma nascosto, una forma di cancro della pelle che appare su parti oscure del corpo. (Altri melanomi nascosti includono il melanoma oculare e il melanoma della bocca.) “Sarà una linea nera dalla base dell'unghia alla fine dell'unghia”, afferma Pichney. “Dovrebbe essere visto da un podologo o un dermatologo. Vuoi assicurarti che non sia un fungo, che di solito è marrone giallo e sporadico in tutta l'unghia. “Sebbene solo il 5% di tutti i casi di melanoma diagnosticati siano di tipo nascosto, il melanoma nascosto è il tipo più comune nelle persone dalla pelle scura. Ecco altri sintomi del cancro della pelle che non sono presenti sulla pelle.

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Un arco improvvisamente alto

Potrebbe essere: Danni ai nervi. “La maggior parte dei piedi arcuati sono associati a una qualche forma di condizione neuromuscolare sottostante”, afferma Pichney. “Se qualcuno ha il diradamento dei muscoli dell'arco nel piede, potrebbe essere un'indicazione di una condizione neurologica chiamata Charcot-Marie-Tooth (CMT).” Un disturbo ereditario che danneggia i nervi periferici (quelli al di fuori del cervello e delle corde spinali) , La CMT può anche causare cambiamenti nell'andatura, intorpidimento dei piedi, difficoltà di bilanciamento, perdita di muscoli nella parte inferiore delle gambe e, in seguito, sintomi simili nelle braccia e nelle mani. Consulta il tuo medico se noti anomalie. “Per tutto ciò che è diverso o cambia quando si tratta di un piede, consulta subito il tuo podologo”, afferma Reid. Fai anche attenzione a questi modi subdoli in cui i tuoi piedi possono disturbare il tuo sonno.

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