Hi, been fighting since 1980, tried it all. After 2 shots of Taltz it went away, . I was covered 60 % of my body. The shot is painful, but only for 1 min. Well worth it. 

The objective of this study was to illustrate a statistical conversion method that was developed to derive absolute PASI values from available clinical trial data on relative PASI improvements.

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Background:
In practice, the goal of treatment for patients with psoriasis is to achieve almost clear or clear skin and maintain disease control, regardless of baseline disease severity. However, identifying absolute Psoriasis Area and Severity Index (PASI) values for new treatment goals is challenging, as most clinical trials report relative PASI 50, 75, 90 or 100 improvements but rarely absolute PASI values achieved.

Objective:
Our objective was to illustrate a statistical conversion method that was developed to derive absolute PASI values from available clinical trial data on relative PASI improvements. The results of network meta‐analyses (NMAs) based on these derived data were then compared with those of NMAs based on the corresponding relative PASI improvement data for selected biologics for moderate‐to‐severe psoriasis.

Methods:
The PASI statistical conversion method was applied to relative PASI improvement data for 11 biologic treatment regimens and placebo at 12 weeks using data from 50 published studies. The respective proportions of patients reaching absolute PASI values ≤1, 2, 3 or 5 were then calculated. Frequentist NMAs (Rücker method) were subsequently used to compare efficacy results across relative and absolute PASI data.

Results:
The ranking of included treatment regimens for patients achieving absolute PASI 0 to 8 was aligned with results for relative PASI scores (from 100 to 60) at end of induction therapy. Across the range of PASI scores considered, the most effective treatment regimens based on both absolute and relative PASI NMAs were brodalumab 210 mg every 2 weeks and ixekizumab 80 mg every 2 weeks, followed by guselkumab 100 mg every 8 weeks and risankizumab 150 mg every 12 weeks.

Conclusion:
Data generated using this mathematical model will be useful to inform ongoing scientific discussions on treatment goals in the absence of primary absolute PASI data for all available treatments for moderate‐to‐severe plaque psoriasis.

Phase 3 results of efficacy and safety of two Cosentyx (secukinumab) dosing regimens low dose (LD) and high dose (HD) in children with severe chronic plaque psoriasis over one year.

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Background:
Secukinumab has demonstrated sustained long‐term efficacy with a favourable safety profile in various psoriatic disease manifestations in adults.

Objectives:
Here, the efficacy and safety of two secukinumab dosing regimens [low dose (LD) and high dose (HD)] in paediatric patients with severe chronic plaque psoriasis over one year are reported.

Methods:
In this multicentre, double‐blind study (NCT02471144), patients aged 6 to <18 years with severe chronic plaque psoriasis were stratified and randomized by weight (<25 kg, 25 to <50 kg, ≥50 kg) and age (6 to <12 years, 12 to <18 years) to receive low‐dose (LD: 75/75/150 mg) or high‐dose (HD: 75/150/300 mg) subcutaneous secukinumab or placebo or etanercept 0.8 mg/kg (up to a max of 50 mg).

Results:
Overall, 162 patients were randomized to receive secukinumab LD (n = 40) or HD (n = 40), etanercept (n = 41) or placebo (n = 41). The co‐primary objectives of the study were met with both secukinumab doses (LD and HD) showing superior efficacy compared to placebo (P < 0.0001) with respect to PASI 75 response (80.0%, 77.5% vs. 14.6%) and IGA mod 2011, 0 or 1 response (70%, 60% vs. 4.9%) at Week 12. Both secukinumab doses were superior to placebo (P < 0.0001) with respect to PASI 90 response at Week 12 (72.5%, 67.5% vs. 2.4%). The efficacy of both doses was sustained to Week 52 with secukinumab achieving higher responses vs. etanercept (PASI 75/90/100: LD, 87.5%/75.0%/40.0% and HD, 87.5%/80.0%/47.5.% vs. etanercept, 68.3%/51.2%/22.0% and IGA 0 or 1: LD, 72.5% and HD, 75.0% vs. etanercept, 56.1%). The safety profile of secukinumab was consistent with the adult Phase 3 studies, with no new safety signals identified.

Conclusions:
Both doses of secukinumab demonstrated high and sustained efficacy up to Week 52 with a favourable safety profile in paediatric patients with severe chronic plaque psoriasis.

This phase 3 study investigate the long‐term safety, efficacy, and maintenance of response with halobetasol propionate (HP) and the retinoid tazarotene (TAZ)  lotion.

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Background:
The topical corticosteroid halobetasol propionate (HP) and the retinoid tazarotene (TAZ) are effective in psoriasis treatment. To mitigate adverse cutaneous reactions observed with monotherapy, a fixed‐combination HP 0.01%/TAZ 0.045% lotion has been developed for the treatment of plaque psoriasis in adults.

Objectives:
To investigate the long‐term safety, efficacy, and maintenance of response with HP/TAZ lotion.

Methods:
This was a 1‐year, multicenter, open‐label study in 555 adults with psoriasis (Investigator’s Global Assessment [IGA] score of 3 [“moderate”] or 4 [“severe”] and body surface area [BSA] of 3‐12% at baseline). HP/TAZ was administered once daily for 8 weeks and then intermittently as needed in 4‐week intervals for up to 1 year based on achievement of treatment success (IGA score of 0 [“clear”] or 1 [“almost clear”]). Maximum continuous exposure was 24 weeks.

Results:
Of 550 participants with post‐baseline safety data, 318 (57.8%) achieved treatment success during the study. Of those, 54.4% achieved treatment success within the first 8 weeks; retreatment was not required for >4 weeks in over half (55.3%), and 6.6% did not require any retreatment. Among participants enrolled for the full 52 weeks, 77.5% maintained BSA ≤5% on treatment. There were marked improvements in severity of itching, dryness, and burning/stinging over the study course. The most common treatment‐related adverse events were application site reactions of dermatitis, pruritus, pain, and irritation.

Conclusions:
Fixed‐combination HP/TAZ lotion provided maintained efficacy with a favorable tolerability and safety profile, supporting its use for the long‐term treatment and management of moderate‐to‐severe plaque psoriasis.

This phase three study compared Skyrizi (risankizumab) with Fumaderm (fumaric acid esters)

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Background:
In a phase 3 clinical study, patients from Germany with moderate to severe psoriasis who were naïve to systemic treatment and received risankizumab had greater and more rapid disease improvements compared with those who received fumaric acid esters (FAEs).

Objective:
To evaluate patient‐reported outcomes (PROs) in patients treated with risankizumab compared with FAEs.

Methods:
Adult patients were randomized 1:1 to receive either risankizumab 150 mg subcutaneous injections at Weeks 0, 4, and 16 or FAEs (Fumaderm®) provided according to the prescribing label. PRO secondary endpoints assessed were Psoriasis Symptom Scale (PSS), Dermatology Life Quality Index (DLQI), 36‐Item Short Form Health Survey, version 2 (SF‐36v2), Patient Benefit Index (PBI), Hospital Anxiety and Depression Scale (HADS), Patient Global Assessment (PtGA), and European Quality of Life 5 Dimensions 5 Level (EQ‐5D‐5L). PROs were assessed at Weeks 0, 16, and 24.

Results:
Sixty patients each were randomized to receive risankizumab or FAEs. A significant PSS improvement was observed with risankizumab versus FAEs at Weeks 16 and 24 for total and psoriasis‐associated redness, itching, and burning scores (P<0.001). DLQI scores were significantly lower (reflecting better health‐related quality of life) with risankizumab versus FAEs, with least squares (LS) mean differences of −7.4 and −7.6 at Weeks 16 and 24, respectively (both P<0.001). Patients randomized to risankizumab also had larger improvements in SF‐36 Physical and Mental Component Summary scores, HADS anxiety and depression scores, PtGA, and EQ‐5D‐5L index and visual analog scale scores (all P≤0.002) at Weeks 16 and 24 compared with FAEs. PBI was significantly higher, indicating greater benefit, with risankizumab versus FAEs, with an LS mean difference of 1.1 and 1.3 at Weeks 16 and 24, respectively (both P<0.001).

Conclusions:
Risankizumab provides significant benefits over FAEs in improving PROs across several dimensions in patients with moderate to severe psoriasis.

Sun Pharma announces initiation of Phase 2 Clinical Trial of SCD-044 in Patients with Moderate to Severe Plaque Psoriasis.

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Sun Pharmaceutical today announced that it has initiated Phase 2 clinical trial for SCD-044 (a novel,orally bioavailable sphingosine-1-phosphate(S1P) receptor 1 agonist) in patients with moderate to severe plaque psoriasis.

The Phase 2 study is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SCD-044 in the treatment of moderate to severe plaque psoriasis.The study will enrol approximately 240 subjects and topline results are expected in 2022.

SCD-044 is a novel orally bioavailable S1P receptor 1 agonist for the treatment of inflammatory diseases such as atopic dermatitis and psoriasis. S1P receptor 1 agonists are promising for the treatment  of  autoimmune  inflammatory  diseases  as  they  cause  diminished  migration  of lymphocytes out of lymphatic tissue.

This results in a decrease of circulating lymphocytes, thereby reducing inflammation. A Phase 1 study of SCD-044 has been completed in healthy volunteers. This study established clinical  proof-of-concept  for  SCD-044in  terms  of  its safety  and pharmacodynamic  effects. Lymphocyte  count  reduction, a  surrogate  marker  of  efficacy forS1P receptor 1 agonists, was observed at all dose levels evaluated.

Skyrizi (risankizumab) Phase 3 Results Demonstrate Improvements in Disease Activity Across Joint and Skin Symptoms Among Psoriatic Arthritis Patients.

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AbbVie today announced positive top-line results from two Phase 3 studies in adults with active psoriatic arthritis, KEEPsAKE-1 and KEEPsAKE-2, showing that significantly more patients treated with risankizumab (150 mg) achieved the primary endpoint of ACR20 response at week 24 versus placebo. In KEEPsAKE-1 and KEEPsAKE-2, 57 and 51 percent of patients receiving risankizumab achieved ACR20 response at week 24, respectively, versus 34 and 27 percent receiving placebo (p<0.001).

Results of ranked secondary endpoints showed significant improvements in skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]), physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) and minimal disease activity (MDA) at week 24. These two Phase 3 studies evaluated risankizumab in adult patients with active psoriatic arthritis, and included patients who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

"We are encouraged by these positive results showing the potential of risankizumab in psoriatic arthritis," said Michael Severino, M.D., vice chairman and president, AbbVie. "These results underscore our commitment to research that can provide health care practitioners with important treatment options for patients with psoriatic disease."

How confident do you feel talking to others about psoriasis ?

Members and guests can vote in the poll above, and our members are welcome to post in this thread too if they wish.

*Members usernames will not be shown

Hi everyone, my name is Charles. I have psoriasis since teenage in 1984 (after a serie of strep throat) and as most of us i went throught all kind of treatment from coaltar, steroid, UV, neotigason (30 years)....and luckily I was put under Cosentyx 5 years ago and it has just change my life by solving this issue....
...i have a question though : my wife and I are thinking about moving to Canada... i was wondering if it s possible to receive cosentyx there, and if so, is the treatment refund through the national health insurance, or is it paid by private insurance only? And also would you know how much it cost to pay it without insurance?
It s an important question because the cost of these treatments are so high that it would be hard to self finance them (and i have discovered that the price of cosentyx in the US could cost up to 3x the price in Switzerland...).
Thank you for your help,
Charles

I think this is a question we are going to asked a lot, so I thought it would be a good idea to keep what we know in one place.

There are two types of vaccine. "Live (attenuated vaccine)" and "Dead (inactivated vaccine") currently 4 Live and 19 Dead are in the running. 0 Live and 5 Dead are in human trials, the 5 Dead vaccines are being used under emergency use in some countries.

People using Bio's or Methotrexate to treat psoriasis are advised not to take Live Vaccines, but as (at the time of writing) none of the 5 vaccines being used are Live then it should be ok to take the Covid Vaccine.

*Note: You should always check with the person prescribing your treatment.

Aldeyra Therapeutics announced the initiation of Phase 2 clinical trials of ADX-629, a first-in-class orally administered reactive aldehyde species (RASP) inhibitor, for the treatment of COVID-19, atopic asthma, and psoriasis.

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Aldeyra Therapeutics today announced the initiation of Phase 2 clinical trials of ADX-629, a first-in-class orally administered reactive aldehyde species (RASP) inhibitor, for the treatment of COVID-19, atopic asthma, and psoriasis as part of a systematic strategy to assess activity across different types of immunological diseases. The Phase 2 clinical trials follow a successful Phase 1 clinical trial of ADX-629, which demonstrated no treatment-related adverse events at any dose tested, as well as target engagement evidenced by statistically lower RASP levels in drug-treated subjects relative to controls.

“The initiation of Phase 2 clinical testing of ADX-629, a first-in-class orally administered RASP inhibitor, is an exciting milestone for Aldeyra as we broaden the focus of our RASP platform from ocular indications to systemic disease,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “The Phase 2 clinical trials announced today underscore our mission to develop new therapies that improve patient outcomes by fine-tuning the body’s immune response. Unlike traditional immunologic drugs, ADX-629 is designed to modulate the immune system rather than shut down singular molecular targets, an approach that may lead to toxicity.”

COVID-19 – A Clinical Model of Cytokine Release Syndrome
The multi-center, double-blind, placebo-controlled, parallel-group Phase 2 clinical trial in COVID-19 will evaluate the safety, tolerability, efficacy, and pharmacodynamics of ADX-629 in adult patients. Approximately 30 patients will be randomized to receive either 300 mg of ADX-629 or placebo twice daily for up to 28 days. Key endpoints will include the National Institute of Allergy and Infectious Diseases COVID-19 scale and plasma levels of cytokines and RASP. Enrollment is expected to begin by year-end.

Atopic Asthma – A Clinical Model of Allergic Inflammation
The single-center, double-masked, placebo-controlled, crossover Phase 2 clinical trial will assess the safety and efficacy of ADX-629 in adult patients with mild asthma induced by bronchial asthma challenge. Twelve patients with cat or house dust mite allergen-induced asthma will be randomized to receive either 600 mg of ADX-629 or placebo twice daily for approximately one week. Outcomes will include pulmonary function testing following allergen and methacholine challenge, sputum eosinophil counts, and plasma levels of cytokines and RASP. Enrollment is expected to begin in the first quarter of 2021.

Psoriasis – A Clinical Model of Autoimmune Disease
The multi-center, open-label, single-group Phase 2 clinical trial will assess the safety and efficacy of ADX-629 in adult patients with mild to moderate plaque psoriasis. Ten adult patients will receive 250 mg of ADX-629 twice daily for up to 90 days. Outcomes will include psoriasis area and severity index, skin cytokine transcription profiles, plasma leukocyte cytokine release following endotoxin-challenge, and plasma levels of cytokines and RASP. Enrollment is expected to begin in the first half of next year.

“We believe that ADX-629 has broad applicability to systemic immune-mediated diseases,” Dr. Brady said. “We look forward to characterizing more fully the immune modulating activity of ADX-629 in multiple types of severe inflammation.”

This study assesses CJM112 effects on safety and efficacy in patients with moderate to severe plaque psoriasis.

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Background and objective:
Anti IL‐17A IgG/κ monoclonal antibody CJM112 binds both IL‐17A and IL‐17AF. The purpose of this First‐in‐Human study was to assess CJM112 effects on safety and efficacy in patients with moderate to severe plaque psoriasis.

Methods:
This study had two parts: single ascending doses of 5–450 mg subcutaneous (s.c.) CJM112 (SAD) and multiple‐dose parallel‐groups of CJM112 15 mg, 50 mg, 150 mg s.c. low frequency or high frequency (MD). SAD/MD were double‐blind, randomised and placebo controlled; MD also included a secukinumab 150 mg s.c. arm as an active comparator. Patients 18‐65 years with moderate to severe psoriasis were included in this study. The efficacy outcome was the change in Psoriasis Area Severity Index [PASI] from baseline to Week 4 in the SAD part of the study, and from baseline to Week 12 in the MD part.

Results:
96 patients were enrolled in this study (SAD, n=42; MD, n=54). In SAD, CJM112 doses from 15 mg and above demonstrated higher PASI responses compared to placebo at Week 12. CJM112 450 mg did not add further efficacy, but efficacy was prolonged compared to CJM112 150 mg. CJM112 MD resulted in a dose‐dependent decrease in PASI over time to Week 12. CJM112 150 mg high frequency did not exceed the effect of CJM112 150 mg low frequency, and had similar efficacy to secukinumab 150 mg. The safety profile of CJM112 was as expected for an antibody targeting IL‐17A/IL‐17AF.

Conclusions:
CJM112 had clinical efficacy in moderate to severe psoriasis and was generally safe and well tolerated in the doses tested. Additional neutralisation of IL‐17AF did not translate to increased clinical efficacy compared to secukinumab.

As you will know at Psoriasis Club our members have been kept updated about using their treatments with the threat of covid.

But now there is a vaccine on the horizon I was wondering how many of you will be happy to give the new vaccines a try, so let's have a poll. This is open to members and guests, members usernames will not be shown but you are welcome to comment if you wish.

I have been on a PBD (plant based diet) for 2 years.  My psoriasis slowly got worse with natural treatment (beeswax, avocado oil, almond oil, shea, vit E, coconut, cocao combinations).  I have just started a Dovobet ointment treatment.  

I think exercise is important and I do eat meat occasionally.  I use grapeseed oil to make pancakes and fry onions and garlic.  I have one or 2 drinks of alcohol a day.

So, short history few years back I had tingling in my pinky finger after nerve conductivity turned out I had cubital tunnel syndrome so they moved the nerve, then about a year after that same thing in my other hand.  I mention this only as it could pertain to the current issue.

About 4-5 days ago I woke up with my left arm feeling asleep from the elbow down into my hand.  A bit worrisome but I thought I had most likely slept wrong and pinched a nerve and it would go away.  But it hasn't, it does feel better at times and worse at times so not sure why and it's mostly towards the wrist and the last three fingers of my hand (although with numbness it really is hard to tell exact spots)  So I decided to google possible causes.  The one that stood out the most as it described it the closest was one that suggested possible psoriatic arthritis.  So does that sound familiar to any of you?  The rheumatologist already has given me a that diagnosis due to my ankles so that also makes me wonder.  Curious if it is a symptom anyone here experienced.

Janssen will present data showing Tremfya (guselkumab) improved fatigue in patients with psoriatic arthritis.

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The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which showed TREMFYA® (guselkumab) improved fatigue in adult patients with active psoriatic arthritis (PsA) and maintained response through 52 weeks of active treatment, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale. TREMFYA improved fatigue during the placebo-controlled periods of both studies at week 24, and through one year of active treatment. In both studies, TREMFYA had positive effect on fatigue, in addition to other clinical outcomes, including ACR20 response. TREMFYA is FDA-approved for administration as a 100 mg subcutaneous (SC) injection every eight weeks (q8w), following two starter doses at weeks 0 and 4.

Data assessing fatigue outcomes of the studies will be presented as a poster presentation (Abstract #0347) on Friday, November 6 from 9:00 - 11:00 a.m. EST during ACR Convergence 2020, the American College of Rheumatology (ACR) virtual annual meeting.

Fatigue is considered one of the three most important symptoms by patients with active PsA, and moderate to severe fatigue occurs in up to 50 percent of these patients. Fatigue is defined as an overwhelming, sustained sense of exhaustion and decreased capacity for physical and mental work. It includes a range of experiences, from tiredness to exhaustion, which can interfere with normal daily function and reduce health-related quality of life. Fatigue is ranked high by patients regarding impact on life and priority for improvement.

"Fatigue associated with psoriatic arthritis can have a serious impact on patients' health-related quality of life and can lead to social isolation and loss of employment," said Proton Rahman,i M.D., Professor of Medicine, Rheumatology, Memorial University in Newfoundland, Canada and presenting author of the study. "These findings from the DISCOVER-1 and DISCOVER-2 studies showing an improvement in fatigue a full year into treatment with TREMFYA add to the previously presented 52-week data demonstrating an improvement in joint and skin symptoms. Considered together, the data are encouraging for active psoriatic arthritis patients who struggle with multiple symptoms."

Novartis say significant reduction of synovitis (joint lining inflammation) was demonstrated with Cosentyx (secukinumab) at week 12  vs. placebo, with improvements as early as week 11.

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Novartis today announced 12-week results from the first-of-its-kind Phase IIIb ULTIMATE randomized controlled trial, which demonstrated the significant treatment response of Cosentyx® (secukinumab) on synovitis (joint lining inflammation) in psoriatic arthritis (PsA) versus placebo. Synovitis was assessed using an advanced and sensitive imaging technique called Power Doppler ultrasonography (PDUS). These data are being presented at the American College of Rheumatology (ACR) All-Virtual Annual Meeting, November 5-9, 2020.

“Psoriatic arthritis can have a significant impact on a patient’s joints. Joint lining inflammation, also known as synovitis, if left untreated, can cause pain to worsen, joint damage and may decrease physical function,” said Dr. Maria A. D’Agostino, Professor of Rheumatology at the Catholic University of Rome. “These data are highly encouraging, showing Cosentyx can significantly reduce synovitis at Week 12 versus placebo with results seen as early as Week 1, and that ultrasound is a sensitive and objective tool to monitor joint inflammation in PsA patients.”

The use of a standardized ultrasound synovitis score (GLOESS) as the primary endpoint showed objectively the significant benefit of Cosentyx versus placebo on synovitis at Week 12 with an early improvement observed from Week one. Treatment with Cosentyx also significantly improved key secondary endpoints versus placebo, including ACR20 (68% vs 34%, respectively), ACR50 (46% vs 9%, respectively) and enthesitis (mean change from baseline in Spondyloarthritis Research Consortium of Canada enthesitis index score [SPARCC] of -2.4 vs -1.7 respectively). The safety profile of Cosentyx through 12 weeks was consistent with previous studies.

Novartis anticipates disclosing full 24-week data from the ongoing ULTIMATE trial at the European League Against Rheumatism (EULAR) annual meeting in 2021 and final analysis at ACR 2021.

"As a strong believer in the diagnostic and treatment monitoring benefits of ultrasound, this first large randomized double-blind placebo-controlled clinical trial in PsA with an ultrasonographic primary endpoint is incredibly exciting. The ability to use a sensitive imaging technique to assess synovitis and enthesitis in PsA represents a breakthrough in how we conceptualize treatment goals,” said Dr. Catherine Bakewell of Intermountain Medical Group in Salt Lake City, UT and an investigator in the ULTIMATE study. “In addition to other measures, PDUS helps to provide earlier insight into treatment response, and that patients are more effectively treated across multiple domains of this heterogeneous psoriatic disease spectrum.”

PsA is a complex disease with multiple manifestations driving patient symptoms. In PsA, synovitis may lead to joint damage and if left untreated, the joint damage can be irreversible. In addition to reducing synovitis, Cosentyx has been proven to provide long-lasting inhibition of radiographic progression in PsA, limiting joint damage and helping to improve outcomes for patients with this debilitating condition.

Bristol Myers Squibb have announced phase 3 trial evaluating the efficacy and safety of deucravacitinib, the first and only novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor.

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Bristol Myers Squibb today announced positive results from POETYK PSO-1, the first pivotal Phase 3 trial evaluating deucravacitinib (BMS-986165), a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-1 evaluated 6 mg of deucravacitinib once daily and met both co-primary endpoints versus placebo, with more patients achieving Psoriasis Area and Severity Index (PASI) 75, defined as at least a 75 percent improvement in PASI, and a static Physician’s Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib.

The trial also met multiple key secondary endpoints, including showing deucravacitinib was superior to Otezla® (apremilast) in the proportion of patients reaching a PASI 75 response and sPGA 0/1 at Week 16. The overall safety profile of deucravacitinib in the POETYK PSO-1 trial was consistent with previously reported Phase 2 results.

“With limited oral therapeutic options available for psoriasis, there remains a significant need for safe and effective oral therapies. This makes the positive topline results for deucravacitinib in the POETYK PSO-1 trial exciting for the psoriasis community,” said April Armstrong, M.D., M.P.H., Associate Dean and Professor of Dermatology at the University of Southern California. “These findings indicate deucravacitinib has the potential to be a new treatment option for people living with psoriasis and may provide clinically meaningful improvements with the convenience of oral administration.”

The company and principal investigators will complete a full evaluation of the POETYK PSO-1 data and share the detailed results at a future medical meeting. POETYK PSO-1 is the first of two global Phase 3 studies designed to evaluate safety and efficacy of deucravacitinib compared to placebo and Otezla in patients with moderate to severe plaque psoriasis. Results from the second study, POETYK PSO-2, are expected in the first quarter of 2021. In addition to psoriasis, deucravacitinib is being studied in a wide spectrum of immune-mediated diseases, and the company will present results from its Phase 2 trial in psoriatic arthritis at the American College of Rheumatology (ACR) Convergence 2020, taking place virtually November 5-9, 2020.

“We are encouraged by the efficacy and safety profile observed in the POETYK PSO-1 study, which supports the strong potential we see for deucravacitinib, our novel, oral, selective TYK2 inhibitor, to be an important new therapy in psoriasis,” said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. “We recognize there is a significant unmet need for new therapeutic options for people with immune-mediated diseases, such as psoriasis, and are committed to pursuing potential new medicines that will give physicians additional choices to effectively treat and manage their patients.”

Sun Pharma have published 5 year results for Ilumya / Ilumetri (tildrakizumab)

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Sun Pharma today  announced  that  one  of  its  wholly  owned subsidiaries presented positive, five-year Phase 3 data for ILUMYA® (tildrakizumab-asmn) from the combined  reSURFACE  1  and  reSURFACE  2  extension  studies.  Patients  with  moderate-to-severe plaque  psoriasis  who  continued  to  receive  ILUMYA  through  five  years  of  continuous  treatment maintained consistent and extensive skin clearance with no new safety issues reported. These data were presented for the first time at the 29th European Academy of Dermatology and Venereology (EADV) Virtual Congress.“These results are important as we now have five-year  data  reinforcing  our  understanding  that ILUMYA may provide patients with sustained skin clearance and a well understood safety profile that was comparable to placebo,”said Richard Langley,M.D.,FRCPC, professor of medicine and director of research, Department of Medicine, Dalhousie University. “ILUMYA is a valued option for patients in  the  treatment  of  moderate-to-severe  plaque  psoriasis,  and  these  findings  are  reassuring  for physicians and their patients living with this chronic disease.”In an analysis of the pooled reSURFACE 1 and reSURFACE 2 extension studies, patients received ILUMYA100mg or 200mg through five years of continuous treatment. ILUMYA 100mg is approved in  the  U.S.,  Japan  and  Australia,  and  200  mg  is  additionally  approved  under  the  brand  name ILUMETRI™ in Europe.

In patients who were treated with ILUMYA 100mg, clear or almost clear skin (PASI 90) was achieved by 65.9% of patients and 32.8% of patients achieved completely clear skin (PASI  100)  at  Week  244.  The  standard  goal of  treatment,  a  PASI  75  response,  was  achieved  by 88.7%  of  patients  at  Week  244.1 The  long-term  analyses  also  showed  absolute  PASI  <1/<3/<5 scores  at  Week  28  (50.8%,  85.1%  and  96.4%,  respectively)  were  sustained  through  Week  244 (47.7%,  78.8%  and  88.7%,  respectively). Absolute  PASI  scores  can  provide  an  indication  of  the extent of residual disease after treatment. Achievement of an absolute PASI score of <3 has been proposed as comparable to a PASI 90 response, which is equivalent to clear or almost clear skin.

ILUMYA  100  mg  was  well-tolerated  during  the  Phase  3  trials.  The  three  adverse  reactions  that occurred more frequently than placebo and ≥1% in clinical trials were upper respiratory infections (14% vs. 12%), injection site reactions (3% vs. 2%) and diarrhea (2% vs. 1%). Furthermore, the analysis  demonstrated  similar  exposure-adjusted  incidence  rates  of  malignancies  throughout  five years  of  study.  A  majority  of  malignancies  were  singular  events  with  similar  incidence  rates  as seen in the general US population.

“These impressive results show that ILUMYA keeps working year-on-year, maintaining a high level of  skin  clearance  and  a  durable  safety  profile  regardless  of  baseline  level  of  skin  disease,  age  or background illnesses,” said Abhay Gandhi, CEO, Sun Pharma, North America. “Patients living with moderate-to-severe plaque psoriasis need therapies they can use over long periods of time without loss of efficacy, and weare pleased these data show that ILUMYA is a sustainable choice for patients over the long term.”

This study looked at psoriasis patients and bullous pemphigoid (BP) a rare skin condition that causes itching, redness and blisters.

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Background:
Although the association of bullous pemphigoid (BP) and psoriasis is well‐established, the clinical and immunological features of patients with coexisting BP and psoriasis are yet to be investigated.

Objective:
We aimed to estimate the prevalence of psoriasis among patients with BP and to elucidate the clinical and immunological characteristics of BP patients with comorbid psoriasis.

Methods:
A retrospective cohort study including all consecutive patients diagnosed with BP throughout the years 2009‐2019 in a tertiary referral center.

Results:
The study encompassed 273 patients with BP, of whom 11 (4.0%; 95% CI, 2.3‐7.1%) had comorbid psoriasis. The onset of psoriasis preceded that of BP in 81.8% of patients by a median (range) latency of 26.5 (5.0‐34.0) years. Compared to BP patients without psoriasis, those with BP and comorbid psoriasis were significantly younger at the onset of BP (71.8 [9.3] vs. 79.4 [9.8] years; P=0.023), had a milder erosive phenotype (erosion/blister BPDAI mean [SD] score; 5 [4.1] vs. 22.3 [15.2]; P=0.025), lower levels of anti‐BP180 NC16A serum autoantibodies (236.6 [266.3] vs. 556.2 [1323.6] U/ml; P=0.008) as well as a higher prevalence of isolated linear C3 deposits (36.4% vs. 14.1%; P=0.043) and a lower prevalence of linear immunoglobulin G deposits (36.4% vs. 68.7%; P=0.025) along the dermal‐epidermal junction by direct immunofluorescence microscopy.

Conclusions:
Patients with BP and comorbid psoriasis present at a younger age with milder erosive phenotype and lower levels of pathogenic autoantibodies.