Category Archives: Psoriasis

Between overcoming an eating disorder in college and managing her psoriasis for the last 25 years, swimmer Dara Torres is fully prepared for any body image conversations her 11-year-old daughter Tessathrows her way.

The 12-time Olympic medalist says the questionshave already started.

She has talked to me actually a few weeks ago about body confidence, because she had to go to an end of the year school party and it was a pool party, and she wanted to talk to me about her body and what swimsuits to wear and having confidence, Torres, 50, tells PEOPLE. And it was the first time she ever really approached me about that on her own. So I was proud of her for being open about that.

Torres says her own background made it easier to relate.

I think the fact that I had an eating disorder in college, and then developing plaque psoriasis, I definitely had some confidence issues and self-esteem issues, she says. So I definitely am completely educated and ready to talk to her about any body image questions she has.

RELATED VIDEO:9 Celebrities Who Struggle with Psoriasis

Dealing with her plaque psoriasis as a young swimmer Torres first noticed the itchy, red rashes as a 25-year-old during the run up to the 1992 Barcelona Games was tough at first.

I was really embarrassed by it, because my business suit is a swimsuit. I needed to be on the pool deck in a little Speedo with these red patches all over me, Torres says.

But gaining the confidence to ignore her psoriasis was key to managing it, particularly because Torres is triggered by stress. Now she works to share that strength with other psoriasis sufferers by working withOtezla and Celgene on their Show More of You campaign.

I want to get the word out that you can have confidence and you can follow your dreams, Torres says. You can be yourself and not worry about what other people think.

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Dara Torres Is 'Ready to Talk' to Her Daughter About Body Confidence After Managing Psoriasis and an Eating Disorder - PEOPLE.com

Liam Gallagher has recalled Oasis first Glastonbury appearance, revealing how fans of the band tried to snort hispsoriasis backstage.

The Britpop groupfirst played Glasto in 1994 and Gallagher remembered a story from that years festival in a recent interview with Noisey.

I remember coming off stage and I got my clothes robbed, Gallagher said. I [also] remember meeting someone, some very strange kid, who come up to me and thought I had cocaine in my hair.

Liam explained: I got psoriasis [skin condition that causes itchy, scaly rashes] so I had obviously been scratching it during the day and that, and there were little white bits and shit. They were takingit out of my hair and putting it on their gums and putting it up their fucking nose. I went like, Okay'.

Watch in the video below at the 2.04 mark.

Earlier today, bookies announced 12/1 odds that Liam and Noel would reunite at Glastonbury 2017.Liamis set to play The Other Stage on Saturday afternoonwhereas his brother is also due to appeartointroduce a special screening of Oasis movie Supersonic.

Elsewhere in the interview, Gallaghershared an anecdote about hanging out with Steve Cooganand gavehis take on why Oasis never fully broke America.

Liam said: I think we were a bit too laddy or English for themIm quite happy with the way it went down in America to be honest. I think if we got big in America id be a proper c*nt.

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Liam Gallagher says that Oasis fans tried to snort his psoriasis at ... - NME.com

So, what does this mean for other biologics in PsO? According to the report, Humira has seen a 16% offset to share over the past year and Enbrel has given up more than 20%. Although future projections show this erosion curve to continue, actual offsets may come at a slower pace, particularly for Humira, which is extremely well-entrenched as a first line biologic, as well as the preferred biologic for certain PsO patient types. Furthermore, AbbVie dominates when it comes to perceptions about manufacturer support for patients, providers, and the dermatology community.

Janssen's Stelara has carved out a solid position as the leading alternative mechanism biologic; however, the IL-17s are expected to catch up in the next six months, essentially flattening Stelara's growth. Indeed, among those expecting to increase their use of IL-17s, close to a third expect a corresponding decrease in the use of Stelara.

Lastly, Celgene's Otezla has maintained a solid position as a psoriasis treatment and dermatologists do project gains in patients with mild and moderate disease. However, only half of the current Otezla patients are classified as "well-managed" compared to 71% of biologic-treated patients. Furthermore, dermatologists identified multiple barriers to increased use of Otezla, including market access challenges, issues with GI tolerability, and sustained efficacy. Until additional oral small molecule products enter the psoriasis market, Otezla has the corner on a market very much in demand by patients.

The next wave of this study, RealTime Dynamix, will field in August and further drivers behind the evolution of this market will be explored next month in RealWorld Dynamix: Psoriasis, a large scale syndicated chart analysis of over 1,000 biologic/apremilast treated patients that have recently switched brands.

All company, brand or product names in this document are trademarks of their respective holders

About Spherix Global Insights Spherix Global Insights is a business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.

For more information contact: Lynn Price, Immunology Franchise Head Email: info@spherixglobalinsights.com http://www.spherixglobalinsights.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/novartis-cosentyx-and-eli-lillys-taltz-bring-disruption-to-the-psoriasis-market-as-il-17-share-increases-dramatically-300477250.html

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Novartis' Cosentyx and Eli Lilly's Taltz Bring Disruption to the Psoriasis Market as IL-17 Share Increases Dramatically - PR Newswire (press release)

June 20, 2017

Improvement in nail psoriasis severity at 16 weeks vs placebo; maintained through 52 weeks

HealthDay News Tofacitinib is associated with improvements in nail psoriasis, according to a study published in the July issue of the Journal of the American Academy of Dermatology.

Joseph F. Merola, MD, from Brigham and Women's Hospital in Boston, and colleagues examined the efficacy of tofacitinib for nail psoriasis treatment over 52 weeks in two identical phase 3 studies. Patients were randomized to receive tofacitinib 5 mg (487 patients), tofacitinib 10 mg (476 patients), or placebo (233 patients) twice daily. Placebo-treated patients were re-randomized at week 16.

The researchers found that significantly more patients receiving tofacitinib 5mg and tofacitinib 10mg versus placebo achieved a 50% reduction in the Nail Psoriasis Severity Index (NAPSI) score from baseline (NAPSI50) (32.8 and 44.2, respectively, versus 12.0 percent), NAPSI75 (16.9 and 28.1, respectively, versus 6.8 percent), and NAPSI100 (10.3 and 18.2, respectively, versus 5.1 percent) at week 16. The improvements were maintained to week 52.

"Tofacitinib treatment resulted in improvements in nail psoriasis versus placebo at week 16; improvements were maintained over 52 weeks," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Pfizer, which manufactures tofacitinib and funded the study.

Abstract Full Text

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Tofacitinib Assessed for Efficacy in Nail Psoriasis - Monthly Prescribing Reference (registration)

Psoriasis, an autoimmune disease that causes itchy, red scale to appear on the skin, is no stranger to the three million people who suffer from it. While itchiness is the most common symptom, in many cases patients also experience painfully inflamed tendons as well joint stiffness.

Unfortunately, the condition remains incurable, but scientists are pointing to a likely remedy to make the disease less insufferable. Thats right, cannabis has some pretty awesome effects on psoriasis.

In a 2007 study researchers concluded that cannabinoids can inhibit the buildup of dead skin cells and other symptoms of psoriasis. The study, which was published in the Journal of Dermatological Science, used different types of cannabinoids including, THC (cannabis most psychoactive component), CBD (one of cannabis least active ingredients) and cannabinol and cannabigerol (other cannabis compounds) all of which were used to examine cannabis anti-inflammatory effects.

Researchers concluded, The cannabinoids tested all inhibited keratinocyte proliferation in a concentration-dependent manner. In other words, the four different cannabinoids they tested were all able to block the buildup of dead skin.

Why does this matter? Well, psoriasis is, essentially, the rapid accumulation of dead skin cells on the surface of the epidermis. So cannabis ability to stop that accumulation is a win, for people battling the inherited disease.

In a not so formal study, researchers at Gwynedd Cannabis Club in Wales, conducted a 9 day experiment in which they treated one subject with acute psoriasis, using cannabis oil. Prior to the experiment, the subject had been using a chemotherapy drug called Methotrexate, known to treat rheumatoid arthritis and psoriasis.

However, the side effects of the drug included fever, diarrhea and increased the chance of infection.

During the 9 day study, the subject was given three doses of topical daily, for nine. Following the treatment, the subject reported no adverse side effects and even noted how she was able to go swimming with her family, which is something she had been limited in doing, due to her psoriasis.

Now, while this study is majority anecdotal, it still serves as another example of cannabis healing powers for people with psoriasis especially in cases where conventional pharmaceuticals cant seem to get it right.

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Marijuana May Be The Hero Psoriasis Patients Need - The Fresh Toast

PEOPLE.com

La La Anthony's Secret to Fighting Psoriasis Is Probably in Your Kitchen PEOPLE.com It is just gentle enough on my sensitive skin, which is really hard to find when you do have psoriasis, the star, who says she confides in close friend and fellow psoriasis-sufferer Kim Kardashian West about which medications work and which don't ...

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La La Anthony's Secret to Fighting Psoriasis Is Probably in Your Kitchen - PEOPLE.com

Novartis AG (NVS - Free Report) announced positive data on arthritis drug Cosentyx from two phase III studies at the Annual European Congress of Rheumatology (EULAR 2017), in Madrid.

Cosentyx, fully human monoclonal antibody, is already approved in the U.S. and EU for the treatment of moderate-to-severe plaque psoriasis. The drug is also approved in the EU for the treatment of adults with ankylosing spondylitis (AS) who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs. The drug is also instrumental for the treatment of active psoriatic arthritis (PsA) in adults when the response to disease modifying anti-rheumatic drug therapy is unsatisfactory.

In Jan 2016, Cosentyx obtained the FDA approval for the treatment of adults with active ankylosing spondylitis and for the treatment of adults with active psoriatic arthritis.

The data shows sustained improvement in the signs and symptoms for active AS at three years. The new data also revealed that Cosentyx provides rapid and sustained pain relief in patients with PsA out to 2 years.

Data from the phase III study, MEASURE 1 extension study, showed 80% of AS patients consistently achieved an ASAS 20 response at 3 years, in tandem with previous findings from the FUTURE 1 study on Cosentyx for active PsA. Additionally, a 2-year post-hoc analysis of the FUTURE 2 study evaluated Cosentyx in PsA, where 99% patients reported moderate-to-extreme pain or discomfort before initiating treatment. At week 3, half of the treated with Cosentyx reported clinically meaningful improvements in pain of over 20%, as measured by Visual Analogue Scale.

Meanwhile, patient recruitment is underway for the new head-to-head clinical trial, EXCEED, to evaluate the superiority of Cosentyx versus AbbVies (ABBV - Free Report) Humira in PsA.

Novartis has outperformed the Zacks classified industry over the last six months. The stock has rallied 12.2% compared with the Large Cap Pharmaceuticals industrys gain of 4.5%.

The uptake of Cosentyx has been strong and the company has grabbed market shares from rivals, Humira and Amgens (AMGN - Free Report) Enbrel. Cosentyx achieved blockbuster status in 2016 recording over $1 billion of sales.

Novartis expects the next growth phase to begin in 2018 driven by Cosentyx (in all three indications psoriasis, psoriatic arthritis and ankylosing spondylitis) Entresto, and Kisqali and a deep pipeline with candidates like CTL019, BAF312, AMG 334, RTH258. Going forward, we expect that the approval of new drugs and label expansion of existing ones will bode well for Novartis.

Zacks Rank & Key Pick

Novartis currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in healthcare sector include VIVUS, Inc. (VVUS - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can seethe complete list of todays Zacks #1 Rank stocks here.

VIVUSs loss per share estimates lessened from 50 cents to 39 cents for 2017 in the last 30 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%.

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Novartis (NVS) Announced Positive Data on Psoriasis Cosentyx - Zacks.com

1. In a posthoc analysis of 2, phase 3 randomized controlled trials of over 1000 patients with moderate-to-severe plaque psoriasis, tofacitinib (an oral Janus kinase inhibitor) treatment demonstrated significantly improved clinical nail psoriasis severity scores at 16 weeks compared to placebo.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Psoriasis is a chronic, inflammatory skin disease associated with clinical manifestations of the nail that include pitting, onycholysis, subungual hyperkeratosis, and discoloration. Nail psoriasis may severely impair function and is associated with significantly greater disease severity and impact on patient quality of life than psoriasis without nail involvement. Tofacitinib is an oral Janus kinase inhibitor that has previously demonstrated efficacy and tolerability in phase 3 clinical trials of moderate-to-severe chronic plaque psoriasis. The purpose of this study was to assess the effect of tofacitinib on nail psoriasis.

This study is a post-hoc pooled analysis of two phase 3 clinical trials evaluating the efficacy of tofacitinib in 1196 patients with nail psoriasis. At the conclusion of the study, both the 5mg and 10mg twice-daily administrations of tofacitinb demonstrated clinically significant improvement in nail psoriasis compared to placebo at 16 weeks with effects maintained at 52 weeks. The results of this study support the use of tofacitinib as a potential treatment modality for nail psoriasis. This study is strengthened by its large sample size, multiple trial sites, randomization, double blinding, and comparison to placebo. The interpretation of study results is limited by the use of only objective measures to assess severity without incorporating subjective patient-reported outcomes. Moreover, non-responders were discontinued from the study at 28 weeks and not included in analysis. Multi-center prospective trials that include patient-reported outcome measures to assess improvements in severity may help improve the validity and of the study.

Click to read the study in JAAD

Relevant Reading: Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials

In-Depth [randomized controlled trial]: This study conducted a pooled posthoc analysis of two identical 52-week multi-site phase 3 randomized controlled trials evaluating the efficacy of tofacitinib in patients with moderate-to-severe chronic plaque psoriasis with nail involvement. Patients in both trials were randomized 2:2:1 to receive tofacitinib 5mg or 10mg, or placebo twice daily. Overall, this study identified 1196 patients with nail involvement of the original 1859 patients with psoriasis recruited in the initial studies. Patients were determined to be moderate-to-severe via a Psoriasis Area and Severity Index score 12, Physicians Global Assessment of moderate or severe, and affected body surface area 10%. Improvements in severity were assessed using the Nail Psoriasis Severity Index (NAPSI). The proportion of patients that demonstrated a 50%, 75% or 100% reduction from baseline in NAPSI score (NAPSI50, NAPSI75 and NAPSI100) were calculated and compared between treatment arms. Patients treated with tofacitinib demonstrated improvement in pitting, onycholysis, subungual hyperkeratosis, and discoloration. Moreover, treatment with tofacitinib demonstrated significantly greater proportions of patients that achieved NAPSI50, NAPSI75 and NAPSI100 compared to placebo at 16 weeks (p < 0.05). Furthermore, the mean number of affected nails decreased from 7.3 at baseline to 3.5 and 2.7 at 52-weeks for the 5mg and 10mg doses, respectively.

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2 Minute Medicines The Classics in Medicine: Summaries of the Landmark Trials is available now in paperback and e-book editions.

This text summarizes the key trials in:General Medicine and Chronic Disease, Cardiology, Critical and Emergent Care, Endocrinology, Gastroenterology, Hematology and Oncology, Imaging, Infectious Disease, Nephrology, Neurology, Pediatrics, Psychiatry, Pulmonology, and Surgery.

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Tofacitinib may be an effective treatment for nail psoriasis - 2 Minute Medicine

June 12, 2017 by Kevin Mccullough Space-filling model of the Cholesterol molecule. Credit: RedAndr/Wikipedia

A new Northwestern Medicine study published in the Journal of Clinical Investigation has demonstrated how a specific class of immune cells represent a previously unknown link between high cholesterol and the development of symptoms characteristic of psoriasis.

Scientists have long known that patients with psoriasisan inflammatory disease that causes itchy, dry and red skinoften have high cholesterol levels, also known as hyperlipidemia. Up until now, however, the cause of this association has been poorly understood.

In the current study, Chyung-Ru Wang, PhD, professor of Microbiology-Immunology, and her colleagues created a strain of mice that contain a category of immune cells called self-lipid reactive T-cells, and also have higher-than-normal amounts of cholesterol in the blood.

"To our surprise, these mice spontaneously developed skin lesions, which were caused by the activation of self-lipid reactive T-cells only under conditions of hyperlipidemia. The skin disease closely matched the symptoms and progression of psoriasis in humans," Wang said.

The findings, according to the authors, may represent an important link between the presence of high cholesterol and the development of psoriasis, a connection that has not previously been explained.

In a separate experiment, Wang and her team examined blood samples from human patients with a psoriasis diagnosis, and found that the levels of those same self-lipid reactive T-cells were elevated in those patients, compared to those without psoriasis.

Taken together, the scientists say the findings of the study are important because they may point to why hyperlipidemia might be linked to the onset of some autoimmune diseases, like psoriasis. Identifying and targeting the antigens that provoke the T-cells in question may represent a future avenue for developing treatments for psoriasis and other hyperlipidemia-associated inflammatory diseases.

Explore further: Psoriasis may up risk of melanoma, hematologic cancer

More information: Sreya Bagchi et al. CD1b-autoreactive T cells contribute to hyperlipidemia-induced skin inflammation in mice, Journal of Clinical Investigation (2017). DOI: 10.1172/JCI92217

(HealthDay)Patients with psoriasis may have a higher risk of melanoma and hematologic cancers than the general population, according to a study published in the April issue of the Journal of the American Academy of Dermatology.

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Psoriasis sufferers may face a higher risk of developing abdominal aortic aneurysms, according to new research in Arteriosclerosis, Thrombosis and Vascular Biology, an American Heart Association journal.

Different types of dendritic cells in human skin have assorted functions in the early and more advanced stages of psoriasis report researchers in the journal EMBO Molecular Medicine. The scientists suggest that new strategies ...

Psoriasis is a common, long-lasting disease that causes itchy or sore patches of thick, red skin with silvery scales. Environmental contaminants can trigger psoriasis and other autoimmune disorders, and it is thought that ...

Psoriasis is a chronic inflammatory disease of the skin and cardiovascular risk factors, including hypertension, are more prevalent among patients with psoriasis compared to those patients without. Previous studies suggest ...

A new Northwestern Medicine study published in the Journal of Clinical Investigation has demonstrated how a specific class of immune cells represent a previously unknown link between high cholesterol and the development of ...

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Exploring high cholesterol's link with psoriasis - Medical Xpress

Dr. LeonardiThe ongoing rush of safe, highly effective systemic agents for psoriasis has created a new era in which substantial numbers of patients may achieve complete clearance, said an expert at the American Academy of Dermatology 75th Annual Meeting, held here.

In the year 2000, said Craig Leonardi, M.D., two authors called complete skin clearance an unrealistic expectation for patients with psoriasis.1

The fact is that right now, we have many drugs that are so far different from what we used to use even five years ago that complete clearance is a realistic possibility in many of our patients, says Dr. Leonardi. He is adjunct professor of dermatology at St. Louis University and a St. Louis, Missouri-based dermatologist in private practice.

As a reference point, he says, Finally, we have numbers for how methotrexate performs in modern measurement systems. In a well-designed 120-patient trial with modest dose escalation, 41% of patients achieved psoriasis area and severity index (PASI) 75, and 66% achieved PASI 50 at week 16.2 This settles the issue of how well methotrexate indeed performs, Dr. Leonardi says. Although no study patients developed pancytopenia, Its always an issue in the back of my mind. At any one time Ill have hundreds of patients on methotrexate. Based on research in rheumatoid arthritis, he says, risk factors include renal disease, hypoalbuminemia, infection, age and concomitant medication use.

New targets

Since the demise of T-cell inhibitors such as alefacept and efalizumab, Dr. Leonardi says, Weve been concentrating on cytokines and cytokine inhibitors. And its been a very busy time in the pharmaceutical industry and for those of us who do this research.

Among tumor necrosis factor alpha (TNFa) inhibitors that dermatologists may not have heard much about, Certolizumab is one you should definitely remember. It is a pegylated TNF-alpha inhibitor, not a monoclonal antibody. In trials, it is a high-performance skin-clearing drug. In phase 3 testing, 81% and 82% in separate cohorts achieved PASI 75.3 Thats functionally equivalent to infliximab. This is a drug you might be able to reach for. You can prescribe it currently for psoriatic arthritis its approved. And based on phase 3 results in psoriasis, We expect it to sail through the approval process.

Recent approvals in the TNF inhibitor category include biosimilar versions of infliximab, etanercept and adalimumab. And there are others in the pipeline.

New indications for existing drugs include hidradenitis suppurativa and uveitis (adalimumab) and pediatric psoriasis (etanercept). Physicians use golimumab mainly for psoriatic and rheumatoid arthritis, he says. It offers very modest results in psoriasis.

We know that psoriasis is a significant cardiovascular risk factor. Patients with severe psoriasis have a marked increased relative risk of myocardial infarction (MI) compared to mild psoriasis4 and, in another analysis, control subjects.

More recently, research analyzing cardiovascular risk in various treatment groups has shown that TNF inhibitors and methotrexate reduce risk of MI around 50%.5 This is the first time we are seeing evidence that treatments can reduce the risk of myocardial infarction, Dr. Leonardi says.

Additionally, an analysis of cardiovascular risk in patients on TNF inhibitors showed a statistically significant, marked decrease of MI risk, starting at around month 12 and lasting several months thereafter, versus patients on methotrexate.6 Even more amazing, cumulative use of TNF antagonists serially reduced the risk of myocardial infarction. Predicted hazard rate reductions at one, two and three years were 21%, 38% and 51%. And theres probably more to be gained beyond three years. What a wonderful story. Were treating their skin and joints and giving them an increased benefit from a cardiovascular risk perspective, he says.

Among interleukin (IL)-23 inhibitors, he says, a straightforward phase 3 study of tildrakizumab (two doses, versus placebo or etanercept) showed that the higher dose outperforms the lower dose 66% versus 61% in terms of both PASI 75 and physician assessments, without noteworthy safety issues.7 With regard to severe infections, malignancies, major adverse cardiovascular events and drug hypersensitivity reactions, all of these issues are comparable to placebo or to etanercept. This drug appears to be safe and well tolerated.

The phase 3 study of guselkumab did not even consider PASI 75 a primary endpoint, Dr. Leonardi says. Rather, 73% of patients reached PASI 90 at 16 weeks, versus 2.9% of placebo-treated patients.8 This is a significant drug. It distinguishes itself quite clearly from adalimumab in terms of efficacy, with comparable safety findings.

In phase 2 testing, a single dose of risankizumab allowed 87% of patients to reach PASI 75, and 58% to reach PASI 90, at 12 weeks.9 And one-third of these patients remained clear for more than 66 weeks. James Krueger, M.D., Ph.D., has called the drug and immunologic disruptor, says Dr. Leonardi, because its pharmacodynamic effect far exceeds its pharmacokinetic effect. Dr. Krueger is D. Martin Carter Professor in Clinical Investigation at Rockefeller University.

IL-17 inhibitors

In secukinumab four-year data, Efficacy whether its PASI 75 (88.5%), PASI 90 (66.4%) or PASI 100 (43.5%) seems to be maintained.10 The caveat is that this is an as-observed analysis. In other words, the denominator is dropping over time as patients achieving lesser efficacy and tolerability drop out. For most patients, Its not surprising that the efficacy should seem stable over time. It would have been a real problem if we saw efficacy dropping off. Regarding serious adverse events, he adds, There are a lot of zeros in the table, including for Crohns disease. There were two cases of ulcerative colitis. This issue of ulcerative colitis and its association with IL-17 antagonists is ongoing, and were going to have to see how that plays out. Its a rare event less than one in 1000 patients in the secukinumab data.

Unpublished five-year data for ixekizumab, in an analysis which accounted for dropouts over time, shows stable PASI 75, 90 and 100 results (approximately 80%, 70% and 47%, respectively), he says. As for AEs that led to drug discontinuation (13), There were many one-off events that dont seem to have any pattern. All adverse events also appear uncommon and stable over time, he added.

The IL-17 receptor antagonist brodalimumab showed efficacy similar to that of ixekizumab in phase 3 trials (86%/85% PASI75, and 37%/44% PASI 100).11 But early in these trials, he says, concerns for depression, suicidal ideation and behavior appeared. There were six suicides in these trials four in the skin trials and two in psoriatic arthritis trials. The FDA remarked that this was an unprecedented collection of serious issues for any psoriasis trial to date. I would take that to heart.

Amgen abandoned the products development in 2015, and Valeant took it to an FDA hearing in July 2016, at which all 18 FDA reviewers recommended approval although 14 advised implementing a strong risk management program. So this drug has a boxed warning for depression and suicide coming out of the gate, and a risk-management system reminiscent of iPLEDGE, he said.

We must wait and see how our specialty reacts to this, how onerous this will be in our offices and whether or not this drug will gain any traction given that equally efficacious drugs with fewer hassles already exist. Moreover, Dr. Leonardi noted that patients with psoriasis have elevated baseline levels of suicidal ideation and depression versus the general population.12

Development of tofacitinib in dermatology has stopped, said Dr. Leonardi. The FDA has returned the application to Pfizer. The problem with this drug is that patients needed a big dose 15 mg twice a day to have outstanding efficacy. But there was a hard safety signal that occurred much earlier at lower doses. FDA officials noted that in rheumatoid arthritis trials, 14 of the 15 patients who died were on tofacitinib. And there were 34 opportunistic infections, he added, all in tofacitinib-treated patients. In the psoriasis trials, there were more than 1,000 cases of herpes zoster.

However, he said, tofacitinib can be useful off-label for indications including alopecia areata, alopecia-associated nail dystrophy, vitiligo and severe atopic dermatitis. When he prescribed 5 mg of tofacitinib twice-daily for a patient with a 15-year history of alopecia universalis and steroid induced adrenal suppression, One year later, she had more hair than I did.

Disclosures: Dr. Leonardi has been a consultant, researcher and/or speaker for Abbvie, Amgen, Celgene, Coherus, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Janssen, Leo, Merck, Merck-Serono, Novartis, Pfizer, Sandoz and Vitae. He also provides phototherapy and has an infusion center.

References

1. Al-Suwaidan SN, Feldman SR. Clearance is not a realistic expectation of psoriasis treatment. J Am Acad Dermatol. 2000;42(5 Pt 1):796-802.

2. Warren RB, Mrowietz U, von Kiedrowski R, et al. An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017; 389(10068):528-537.

3. http://www.ucb.com/stories-media/press-releases/article/CIMZIA-certolizu... http://www.ucb.com/stories-media/press-releases/article/CIMZIA-certolizu.... Published October 3, 2016. Accessed April 7, 2017.

4. Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006;296(14):1735-41.

5. Wu JJ, Poon KY, Channual JC, Shen AY. Association between tumor necrosis factor inhibitor therapy and myocardial infarction risk in patients with psoriasis. Arch Dermatol. 2012;148(11):1244-50.

6. Wu JJ, Gurin A, Sundaram M, Dea K, Cloutier M, Mulani P. Cardiovascular event risk assessment in psoriasis patients treated with tumor necrosis factor- inhibitors versus methotrexate. J Am Acad Dermatol. 2017;76(1):81-90.

7. Reich K, et al. Tildrakizumab, selective IL-23p19 antibody, in the treatment of chronic plaque psoriasis: results from two randomized, controlled, Phase 3 trials (reSURFACE 1 and reSURFACE 2) [abstract]. Presented as a late breaking abstract at the European Academy of Dermatology and Venereology 2016. October 1, 2016.

8. Blauvelt A, Papp KA, Griffiths CE, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017;76(3):405-417.

9. Krueger JG, Ferris LK, Menter A, et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebocontrolled trial. J Allergy Clin Immunol. 2015;136(1):116124; e117. 29.

10. Bissonnette R, et al. Secukinumab maintains high levels of efficacy through 4 years of treatments: Results from an extension to a phase 3 study (SCULPTURE). Paper presented at: European Academy of Dermatology and Venereology Annual Meeting.; October 01, 2016; Vienna, Austria.

11. Lebwohl M, Strober B, Menter A, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015;373(14):1318-28.

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New systemic psoriasis treatments keep raising bar - ModernMedicine