I thought I would share this as I have been told I need three covid jabs.

France have recently reviewed their covid jab strategy and have put patients receiving an Immunosuppressant on three jabs of covid vaccine.

Today Mrs Fred went for her first jab this morning and met our old retired GP, he told her that I should ask about the third jab. As it happened I also had an appointment with my new GP this afternoon and she confirmed that it is being rolled out that anyone taking an Immunosuppressant is to have three shots.

#1 First shot

#2 Second shot 6 - 8 weeks later

#3 Third shot 4 weeks after the second.

When you book here you book your first and second jab dates together, that is about to change and there will soon be an option for those using an Immunosuppressant to book 3 dates. I have had my first jab so I have to phone my GP two days after my second jab and if I have had no problems she will talk to my dermatologist and write a prescription for my third jab 4 weeks later.

Any other countries doing three jabs for patients on an Immunosuppressant ?

It's not big but I thought it my be worth publishing for those using Methotrexate.

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Up to a third of patients taking methotrexate – a common treatment for immune mediated inflammatory conditions such as rheumatoid arthritis and psoriasis/psoriatic arthritis – failed to achieve an adequate immune response to mRNA COVID-19 vaccines in a small study accepted for publication in the journal Annals of the Rheumatic Diseases.

While mRNA COVID-19 vaccines have been shown to produce an effective immune response in over 90% of healthy adults in clinical trials, it is unknown whether the immune response is as robust in patients with immune-mediated inflammatory diseases (IMID) who may also be taking immunomodulatory medications.

The authors assessed the immune response to the mRNA Pfizer-BioNTech COVID-19 vaccine in 82 patients with immune-mediated inflammatory diseases (mainly psoriasis/psoriatic arthritis and rheumatoid arthritis) receiving methotrexate or an alternative immunomodulator (mainly TNF inhibitors and other biologics) at two centres – New York University Langone Health (New York, USA) and FAU Erlangen-Nuremberg and Universitatsklinikum Erlangen (Erlangen, Germany).

The study found that the Pfizer-BioNTech vaccine induced adequate antibody levels in up to a third fewer patients on methotrexate, when compared with healthy participants and patients with IMIDs on the other immunomodulatory drugs.

Adequate antibody levels were produced in over 90% of the 208 healthy participants and 37 patients on biologic or non-methotrexate oral treatments, but in only 62% of the 45 patients taking methotrexate.

Furthermore, while the vaccination induced activated CD8+ T cell responses in healthy participants and patients with immune-mediated inflammatory diseases not on methotrexate, this same induction was not seen in those patients on methotrexate. T cells are another part of the body’s immune defence system.

This is an observational study, and as such, can’t establish causality. The authors also acknowledge that the study had a small sample size, only assessed one type of mRNA COVID-19 vaccine, and could have included patients with previously asymptomatic COVID-19 infections.

They also point out that IMID patients on methotrexate were generally older than the comparison group (average age 63 vs 49) which may potentially explain some differences in immunogenicity.

Additionally, the authors emphasize that “it is not yet clear what level of immunogenicity is representative of vaccine efficacy.”

They go on to note that “although precise cut offs for immunogenicity that correlate with vaccine efficacy are yet to be established, our findings suggest that different strategies may need to be explored in patients with immune-mediated inflammatory diseases taking methotrexate to increase the chances of immunization efficacy against SARS-CoV-2 as has been demonstrated for augmenting immunogenicity to other viral vaccines.”

Methotrexate, for example, has previously been shown to reduce the immune response to the influenza vaccine.

The authors add: “Our results suggest that the optimal protection of patients with IMID against COVID-19 will require further studies to determine whether additional doses of vaccine, dose modification of methotrexate, or even temporary discontinuation of this drug can boost immune response as has been demonstrated for other viral vaccines in this patient population.”

This study in Greece looked at the effectiveness and safety of Otezla (apremilast) in biologic-naïve patients with moderate psoriasis.

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Background:
Apremilast is an oral phosphodiesterase-4 inhibitor indicated for patients with moderate-to-severe chronic plaque psoriasis and active psoriatic arthritis.

Objectives:
To examine the effectiveness of apremilast on Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), and nail, scalp, and palmoplantar involvement, when administered prior to biologics.

Methods:
This 52-week real-world study included biologic-naive adults with moderate psoriasis (psoriasis-involved body surface area 10% to <20%, or PASI 10 to <20 and DLQI 10 to <20). Apremilast was initiated ≤7 days before enrolment. Data from the first 100 eligible patients who completed 24 weeks (W24) of observation (or were prematurely withdrawn) are presented in this interim analysis using the last-observation-carried-forward imputation method.

Results:
Eligible patients (mean age: 49.9 years; 71.0% males; median disease duration: 8.0 years) were consecutively enrolled between April and October 2017, by 18 dermatology specialists practicing in hospital outpatient settings in Greece. Baseline DLQI (median: 12.0) and PASI (median: 11.7) scores improved (P<0.001) at all post-baseline timepoints (Weeks 6, 16, and 24; W24 median decreases: 9.0 and 9.4 points, respectively). At W24, DLQI ≤5, DLQI 0 or 1, and PASI-75 response rates were 63.0%, 25.0%, and 48.0%, respectively. The Nail Psoriasis Severity Index score in patients with baseline nail involvement (n=57) decreased at all post-baseline timepoints (P<0.001; W24 median decrease: 20.0 points). At W24, 50.0% and 51.7% of patients with baseline scalp (n=76) and palmoplantar (n=29) involvement, respectively, achieved post-baseline Physician’s Global Assessment (PGA) score 0 or 1 if baseline score was ≥3, or 0 if baseline score was 1 or 2. The adverse drug reaction rate was 21.0% (serious: 2.0%).

Conclusions:
These interim results indicate that through 24 weeks, apremilast improved quality of life and reduced disease severity in biologic-naive patients with moderate plaque psoriasis, while demonstrating safety consistent with the known safety profile.

Some of my fingernails are lifting off the nail bed. I am active and do yard work, repairs of all sorts etc. I wear nitril rubber gloves as much as possible but even then they split, and even when they don't somehow I seem to get dirt lodged down in the middle of my fingernail. I am looking for ways to remove the dirt that a nail file won't reach. I have read that it's not good to scrape the areas that the nail is supposed to be attached.

Any suggestions how to clean them once they get some dirt under them?

Any suggestions to help keep them clean when I am active?

Thanks

Here you will find the latest reliable news about psoriasis.

As most of you know I keep up to date with everything going on in the world of psoriasis and any information I get I make sure it's genuine and from a reliable source before publishing it on Psoriasis Club. This keeps us free from spammers and scammers, as well as avoiding free advertising for other websites.

Only myself (Fred) will be able to start new threads in this section but all our members are welcome to post their own views on a news item if they wish.

I don't miss much when it comes to good reliable psoriasis news, but if you feel I may have missed something our members with more than 5 posts can post in the [Group Specific] where we can go through it together and see if it is worthy of publication on Psoriasis Club.

The other health boards are still there for all members to use and by moving news here it should help our members find threads easier. If you want to get notification of a new thread in this new section our members can subscribe see here: Notification of new threads and posts

*This is a new board and there may be some teething troubles, so do let me know if you spot anything wrong.

I have a derm who is very helpful. I have Ps and maybe PsA. I would like to try a drug that will be good for both ailments. She has given me the option of requesting what drug I would like to try.

If you had your choice what would you choose?

The Physician’s Global Assessment of Fingernail Psoriasis (PGA-F) is a rapid, valid, and reliable clinician-rated severity scale.

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Background:
Several clinician-rated scoring systems are available to assess nail psoriasis severity, but only one has been partially validated.

Objective:
To develop and validate the Physician’s Global Assessment of Fingernail Psoriasis (PGA-F), a new clinician-rated severity scale.

Methods:
A literature review, concept elicitation, pilot cognitive debriefing, and clinical expert consultations informed development of the PGA-F. A multi-stage mixed methods analysis consisted of practicing dermatologist cognitive interviews (n=10) for instrument clarity, relevance, and comprehensiveness. Inter-rater reliability (IRR) of ratings from dermatologists (n=22) and clinical trial investigators (n=8) was tested using many-facet Rasch analysis. Concurrent validity between the PGA-F and modified Nail Psoriasis Severity Index (mNAPSI) at screening and baseline was assessed along with degree of discrimination. Intraclass correlation coefficient (ICC) for single raters at multiple assessments determined IRR.

Results:
The PGA-F synthesizes severity ratings across multiple disease features that classifies individuals into 1 of 5 levels (clear to severe). Cognitive interviews confirmed content validity: all (n=10, 100%) participants agreed clinical criteria were consistent with nail psoriasis; no mismatched severity levels; and training photographs were realistic representations. All PGA-F items were locally independent and targeted patients along the severity continuum with complementary precision (item fit statistics: < the 1.5 acceptability threshold; exact agreements amongst the dermatologists [44%] and trial investigators [61.5%] exceeded 40% acceptability threshold). Clinician reliability exceeded the threshold of acceptability for dermatologists and clinical trial investigators: 0.85 and 0.73, respectively. There was adequate correlation (>0.30) between mNAPSI and PGA-F at baseline and Week 26 with significant discrimination of severity and monotonic increases on the mNAPSI for each level of categorical severity on the PGA-F. ICC results for each type of IRR indicate that clinicians were consistent in individual patient ratings.

Conclusion:
The PGA-F is a rapid, valid, and reliable clinician-rated severity scale for use in clinical practice and research.

This study evaluated drug survival for methotrexate (MTX) monotherapy in patients with plaque psoriasis.

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Background:
Drug survival is useful to evaluate long-term drug performance in daily practice. The aim of this study was to evaluate drug survival for methotrexate (MTX) monotherapy in patients with plaque-type psoriasis.

Methods:
We reviewed 3,512 follow-up charts of patients with psoriasis at five tertiary referral centers between January 2012 and January 2020. We analyzed baseline data and treatment outcomes of patients under MTX monotherapy. Drug survival was analyzed using Kaplan-Meier and Cox regression analyses.

Results:
Patients with psoriasis who were treated with MTX monotherapy were enrolled (N = 649). The median duration of drug survival was 15 months (95% CI: 13.2–16.8). The overall drug survival rate was 54.7%, 17.4%, and 8% after 1, 3, and 5 years, respectively. The main reasons for discontinuation were adverse effects (n = 209, 32.2%) and inefficacy (n = 105, 15.6%). Based on multivariate Cox regression analysis, the presence of nausea/vomiting (HR: 2.01, 95% CI: 1.49–2.71; P < 0.001) was observed as a statistically significant risk factor for drug discontinuation. Age over 50 years (HR: 0.68, 95% CI: 0.48–0.97; P = 0.03) and using MTX dose ≥15 mg/weekly were positive predictors for drug survival (HR: 0.72, 95% CI: 0.54–0.95; P = 0.02).

Conclusions:
The average drug survival of MTX was 15 months. MTX is still the first-line treatment of moderate-to-severe plaque psoriasis, as highlighted in guidelines. To prevent premature discontinuation, physicians need to look at the response time of at least 16–24 weeks, especially when a stepwise dose increment is used. The presence of nausea/vomiting seemed to be associated with an approximately twofold risk of discontinuation.

This study looked at the various forms of scalp psoriasis.

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Background:
Scalp psoriasis is often undiagnosed or inadequately treated. The patient himself underestimates the seriousness of this hair disease and consults too late to a dermatologist.

Objectives:
The aim of our study was to create a correlation between the clinical patterns and trichoscopy of scalp psoriasis such in a way to help the clinician to make the diagnosis and select the appropriate therapy.

Material & Methods:
We gathered all patients affected of scalp psoriasis afferent to Outpatient’s hair consultation of the Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, from January 2012 to December 2018. All patients were evaluated through clinical, trichoscopic examination and a skin biopsy only in doubtful cases. We quantified the severity of the disease with several objective and subjective parameters every 4 months, up to 1 year. We recorded therapies, outcome data and quality of life.

Results:
We collected 156 patients affected by scalp psoriasis, identifying 7 clinical patterns with specific trichoscopical correlation. In order of frequency the clinical patterns were: plaque psoriasis (with a prevalence of erythema, silver-white scales and twisted red loops vessels and red dots); thin scales (with silvery-white scales, simple red lines and signet red ring vessels); sebopsoriasis (with greasy scales, erythema with red dots, globules and twisted and bushy red loops at high magnification); psoriatic cap (with silver-white scales, erythema and polymorphic vascular pattern); pityriasis amiantacea (with yellowish adherent scales, erythema and simple red loops capillaries); cicatricial psoriatic alopecia (with erythema associated with yellowish, silver-white scales with twisted and bushy red loops capillaries) and pustular psoriasis (with “flower shape” pustular lesions, erythema simple red loops capillaries).

Conclusions:
The description of different clinical patterns of scalp psoriasis and its trichoscopical correlations may help the clinician to make the diagnosis also in atypical presentations and to prescribe an adequate therapeutic regimen.

In the early stages of my affliction, I paid it no mind. My skin was discolored, but it wasn't painful. I let it be. A year later (2017), I noticed that my knees were reddish. Again, I paid it no mind because it wasn't painful. 6 months later, It started on my elbows. Now I was concerned. I went to a doctor, and he gave me a corticosteroid cream. I used it and I was good to go. There was still redness, but the plaque disappeared. 

As time went on, I was seeing more and more inflammation. It popped up, here and there, so I used the cortisone cream and again had some results. By 2018, the cream wasn't working any longer...at all. I went back to my doctor. He gave me dovobet ointment. Wow! I was impressed. It worked so well. Inflammation was at a near zero on my body. I used the ointment. I had to scrounge to get the money to pay for this med, in spite of it costing me $250 a tube. My doctor kept on refilling the prescription for Dovobet ointment. I kept on using it. He even sent me to a dermatologist where I started to get phototherapy. That was the only thing he did in addition to the Dovobet. in the spring of 2020, the dermatologist told me to take the summer off from the phototherapy and told me to come back in the fall. When I tried to return and make an appointment, the receptionist told me that I had not been to see him in 3 months, so I had to be referred to him again by my family doctor. To date, this dermatologist has yet to return my calls, in spite of 2 referrals from my GP. 

In recent months, I have not been able to afford the ointment, due to being unemployed (government shut down my job due to Covid). My psoriasis exploded! Hands, arms, back, legs, chest, behind the ears, in my ears, on my forehead/eyebrows, eyelids, nose and cheeks were affected. Now I am constantly scratching causing lesions on my body. Blood on the inside of my shirts and pants is a common occurrence because I can't seem to stop itching. Everywhere I go, I leave a trail of skin flakes. When I get up from the couch, get up out of the bed, get out of the car, I see tons of flakes and I wasn't even scratching! I feel so ashamed. 

Passersby stare, kids point and ask about it. I have had the experience of having being singled out at work because of the mess I leave behind, unintentionally. I am embarrassed and shattered by this disease. I feel depressed. I secretly wonder how my wife can even stand to be around me, because I can barely stand to be around me. As a result, depression is a large part of my life.

Fast forward to today, and I am working to remedy my psoriasis. There is actually a new dermatologist in the practice that my general practitioner (GP) is in. I have an appointment on the 13th and am looking forward to it, anxious for it. I am learning lots here and now have some info about what I might need or want for treatments. I am actually feeling hopeful for the first time in a long, long time. 

My commitment to you folks, is to document my journey in hopes that it may help someone else in the future. If I can do that for someone, then all my suffering will have been worth it.

Cheers!

MoonLake Immunotherapeutics have announced results of a Phase 2b study of its Tri-specific Nanobody Sonelokimab an investigational IL-17A/IL-17F inhibitor with an albumin binding site, which has the potential to facilitate deep tissue penetration in the skin and joints.

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MoonLake Immunotherapeutics AG, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory skin and joint diseases, today announced that full results of a Phase 2b study of its Tri-specific Nanobody® Sonelokimab were published in The Lancet. Sonelokimab is an investigational IL-17A/IL-17F inhibitor with an albumin binding site, which has the potential to facilitate deep tissue penetration in the skin and joints. It has clinically demonstrated potential to allow better disease control in dermatology and rheumatology patients. Sonelokimab showed impressive efficacy with a favorable safety profile, and numerically outperformed active control secukinumab.

In the study, dosages up to 120 mg showed rapid and significant clinical benefit compared with placebo. In the highest dosage group, almost 6 out of 10 patients (57%) achieved total skin clearance (PASI 100 response) after 24 weeks. Rapid response was demonstrated with one of three patients already achieving almost clear skin (PASI 90 response) by week 4. Analysis of an individualized dosing scheme including off-drug periods in controlled patients revealed durable responses over one year. Sonelokimab was generally well tolerated, with a safety profile similar to the active control, secukinumab, and an overall candida rate of 7.4%. Although the highest dosage and schedule could be used for future clinical studies, additional assessment and modelling may aid in the final selection of the optimal dosage and schedule. The trial was conducted by Avillion LLP under a 2017 co-development agreement with Merck KGaA, Darmstadt, Germany.

Investigator Kristian Reich MD, PhD, Chief Scientific Officer and co-founder of MoonLake Immunotherapeutics, commented: “Sonelokimab is a remarkable Nanobody with game-changing potential in the treatment of a range of IL-17A/F-driven inflammatory diseases. This study shows very high response levels in the model disease psoriasis, with a favorable benefit-safety profile. MoonLake’s aim is to also accelerate Sonelokimab’s development in other inflammatory diseases driven by IL-17A and IL-17F like psoriatic arthritis, ankylosing spondylitis and hidradenitis suppurativa. Our aim is to elevate treatment goals in these diseases based on the unique characteristics of Sonelokimab, giving patients with common and burdensome skin and joint conditions a chance of better disease control.”

Mark Weinberg, MD, MBA, co-author of the publication and Chief Medical Officer of Avillion LLP, commented: “Following completion of our Phase 2b activities with Merck KGaA, we are excited to see Solenokimab continue in development. Data on this Tri-specific Nanobody demonstrates potential in major inflammatory diseases driven by IL-17A and IL-17F. These diseases have a profound effect on patients’ lives not just physically but emotionally and socially. We’ve seen a continued evolution of biologic therapies in the last 25 years and I am looking forward to seeing further development of this novel nanobody biologic by MoonLake.”

The randomized, double-blind, placebo controlled, multi-center, Phase 2b study was designed to assess efficacy, safety and tolerability of Sonelokimab in subjects with moderate-to-severe chronic plaque-type psoriasis. The trial enrolled 313 patients (age 18-75) with chronic plaque psoriasis for at least six months, with an Investigator Global Assessment (IGA) score ≥3, involved body surface area ≥10%, and Psoriasis and Severity Index (PASI) ≥12 at screening and at baseline. Patients were randomized to one of four dose regimens of Sonelokimab, or a placebo comparator arm, or a reference arm (secukinumab).

This clinical trial significantly expands the number of patients and duration of therapy evaluated for Sonelokimab in plaque psoriasis and represents the first Phase 2 evaluation of a Nanobody® IL-17 A/F inhibitor in psoriasis. The study found Sonelokimab was efficacious in the treatment of plaque psoriasis. The safety profile reflects the mechanism of action with oral Candida as the most reported adverse event, in the same range as IL-17A inhibitors (7.4%).

MoonLake Immunotherapeutics was established by an international team of immunology specialists to accelerate the clinical development of Sonelokimab, building on robust clinical data generated by Merck KGaA, Darmstadt, Germany, and by Ablynx, a Sanofi company, which discovered the molecule.

MoonLake Immunotherapeutics plans to accelerate the development of Sonelokimab in multiple inflammatory diseases in dermatology and rheumatology driven by IL-17A and IL-17F. This group of IL-17A/F Inflammatory Diseases (introducing the novel concept of AFID) includes psoriatic arthritis, ankylosing spondylitis, and hidradenitis suppurativa – conditions affecting millions of people worldwide with a large need for improved treatment options. MoonLake Immunotherapeutics plans to initiate multiple Phase 2 trials soon.

This small study suggests more should be looked at in the role of interleukin 30 (IL-30) and psoriasis

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Objectives:
To examine the serum levels of interleukin (IL)-30 in patients with psoriasis and evaluate the correlations with the Psoriasis Area and Severity Index (PASI).

Methods:
Serum was collected from 26 patients with psoriasis and 26 healthy controls in a case–control setting, and the level of IL-30 was determined using an enzyme-linked immunosorbent assay. Statistical analysis of the IL-30 levels among groups and further correlation analyses of IL-30 levels with PASI scores were performed.

Results:
A significant increase in the level of IL-30 in patients with psoriasis compared with healthy controls was observed. In addition, a positive correlation between the IL-30 concentration and PASI scores was found in patients with psoriasis.

Conclusion:
IL-30 is presumably involved in the proliferation of epidermal cells during the development of psoriasis. Further studies with a larger number of participants are required to comprehensively elucidate the biological roles of IL-30 in the pathogenesis of psoriasis.

This months poll asks: Have you ever been asked if psoriasis is contagious

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 all,  I am new to the Psoriasis club but unfortunately not new to Psoriasis.  Up to now I have mostly managed my psoriasis thru topical treatments but have finally decided to try the more serious stuff as am  just not managing to keep it under control any longer, especially my scalp psoriasis which is now all over my scalp and behind and in my ears.  Am due to pick up my prescription for Skilarence today ?.   Am really nervous of the side effects especially the cramps and diarrhoea. But having read some of the experiences on the forum am feeling a bit more hopeful that I will hopefully be able to deal with them.

From what I have read taking with plenty of water and bland food is important and starting slowly.  Starting today with 1 30mg tablet. Any other recommendations.  Thanks Jean

I am new here. Up until now, I have been given dovobet ointment, with mixed results. Right now I am reading all I can to learn about different treatments so I can go to my doctor with lots of options to dovobet. Mainly I am sick and tired of ruining my furniture with the ointment, and leaving a snail trail everywhere I go. That and the itching is driving me nuts. Embarrassed about the trail of skin flakes I leave behind as well. I also live in Manitoba, Canada and was wondering about treatments and covered drugs, as I am not a rich man by any means.

Lilly have announced in their first quarter results that they will be dropping mirikizumab for psoriasis.

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The company announced that mirikizumab met the primary and all key secondary endpoints in a Phase 3 induction study evaluating the efficacy and safety of mirikizumab for the treatment of patients with moderate to severe ulcerative colitis.

The company announced that the development program for mirikizumab will henceforth focus on the ulcerative colitis and Crohn's disease indications.

While the OASIS program generated positive results for mirikizumab with safety and efficacy similar to other IL-23p19s, the company no longer plans to submit mirikizumab for regulatory approval in psoriasis in any geography.

UCB publish "Be Radiant" and "Be Sure" phase 3 data.

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BE RADIANT RESULTS
The Phase 3b BE RADIANT study compared the efficacy and safety of bimekizumab to secukinumab in adults with moderate to severe plaque psoriasis. The study met its primary endpoint, with significantly more patients treated with bimekizumab achieving complete skin clearance, as measured by a 100 percent improvement from baseline in the Psoriasis Area and Severity Index (PASI 100) at week 16, compared to those treated with secukinumab (61.7 percent versus 48.9 percent, respectively; p<0.001).
The study also met all ranked secondary endpoints.1 The superior levels of complete skin clearance observed at week 16 continued through to week 48, with 67.0 percent of patients treated with bimekizumab, achieving PASI 100, compared to 46.2 percent of patients treated with secukinumab (p<0.001). At week 48, both bimekizumab maintenance dosing groups (every four weeks [Q4W] and every eight weeks [Q8W]), showed higher rates of complete skin clearance (PASI 100), compared with secukinumab (p<0.001). In addition, at week 4, significantly more patients treated with bimekizumab achieved PASI 75 compared to patients treated with secukinumab (71.0 percent versus 47.3 percent, respectively; p<0.001).
“In BE RADIANT, patients treated with bimekizumab achieved superior levels of complete skin clearance, PASI 100, compared with secukinumab-treated patients at week 16, the primary endpoint of the study, and up to 48 weeks of therapy. At week 4, a faster onset of response was also observed with bimekizumab compared with secukinumab.  Data from this study support the value of inhibition of IL-17F in addition to IL-17A in the treatment of patients with moderate to severe plaque psoriasis.” said Prof. Kristian Reich, M.D., Ph.D., Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Germany.
Across the study duration, the most common treatment-emergent adverse events (TEAEs) with bimekizumab were upper respiratory tract infections* (38.9 percent), oral candidiasis (19.3 percent) and urinary tract infection (6.7 percent). Oral candidiasis cases were predominantly mild or moderate and none led to discontinuation. Over 48 weeks, the incidence of serious TEAEs was 5.9 percent with bimekizumab and 5.7 percent with secukinumab.

BE SURE RESULTS
The Phase 3 BE SURE study compared the efficacy and safety of bimekizumab to adalimumab in adults with moderate to severe plaque psoriasis. Results from the BE SURE study were previously reported at the European Academy of Dermatology and Venereology (EADV) Congress 2020.
BE SURE met its co-primary endpoints, demonstrating that bimekizumab-treated patients achieved superior levels of skin clearance, at week 16, compared to those who received adalimumab, as measured by PASI 90 and Investigator’s Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1); p<0.001 for both comparisons. These results were further supported by the study meeting all ranked secondary endpoints. The safety profile of bimekizumab was consistent with earlier clinical studies with no new safety signals identified.
In September 2020, UCB announced that the FDA and EMA had accepted the Company’s Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of moderate to severe plaque psoriasis in adults. UCB is committed to bringing bimekizumab to patients worldwide and additional regulatory filings are underway.

About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively and directly inhibits both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17F has overlapping biology with IL-17A and drives inflammation independently of IL-17A.Selective inhibition of IL-17F in addition to IL-17A suppresses inflammation to a greater extent than IL-17A inhibition alone. The safety and efficacy of bimekizumab are being evaluated across multiple disease states as part of a robust clinical program.

Amgen today announced Otezla (apremilast) improved measures of disease severity in adults with mild-to-moderate plaque psoriasis regardless of their Body Surface Area (BSA) affected by the disease.

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"Many people with mild-to-moderate plaque psoriasis still report challenges in managing their symptoms, which can have a significant impact on their daily lives, despite the availability of existing topical treatment options," said Linda Stein Gold, M.D., director of dermatology clinical research at Henry Ford Health System, Detroit, and lead investigator for the ADVANCE study. "The ADVANCE findings demonstrated that oral apremilast significantly improved clinical measures of disease severity, such as Body Surface Area and scalp involvement."

In ADVANCE, oral Otezla 30 mg twice daily achieved a statistically significant improvement of the primary endpoint of static Physician's Global Assessment (sPGA) response at week 16 compared to placebo (21.6% vs. 4.1%, p<0.0001). These clinical improvements were maintained through week 32.

Otezla also demonstrated improvements in all secondary endpoints at week 16. A greater proportion of adults with BSA ≤5% treated with Otezla compared to placebo achieved a BSA ≤3% (respectively 71.7% vs. 35.8%), at least a 75% improvement in BSA (29.0% vs. 6.1%) and a Scalp PGA (ScPGA) response score of clear or almost clear (35.6% vs. 12.9%).

Comparable improvements in disease severity were seen in adults with BSA >5% in ADVANCE. At week 16, a greater proportion of adults with BSA >5% treated with Otezla compared to placebo achieved a BSA ≤3% (respectively 54.6% vs. 14.9%), at least a 75% improvement in BSA (36.8% vs. 8.6%), and a ScPGA response score of clear or almost clear (50.6% vs. 19.2%).

The adverse events observed in this trial analysis were consistent with the known safety profile of Otezla. The most commonly reported (≥5%) treatment-emergent adverse events with Otezla treatment were diarrhea (14.3%), headache (12.9%), nausea (12.7%), upper respiratory tract infection (8.5%) and nasopharyngitis (6.8%).

"These positive ADVANCE results add to the growing evidence supporting the potential benefit of Otezla in adults with mild-to-moderate plaque psoriasis," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to continuing to work with the FDA to potentially expand access to oral Otezla to adults with mild-to-moderate disease severity."

In the U.S., Otezla is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet's Disease. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 250,000 patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis in the U.S.

Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla (apremilast)

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Bristol Myers Squibb today announced positive results from two pivotal Phase 3 trials evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated deucravacitinib 6 mg once daily, met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI) 75 response and a static Physician's Global Assessment score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib. Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events (AEs).

Deucravacitinib demonstrated superior skin clearance compared with Otezla® (apremilast) for key secondary endpoints in both studies, as measured by PASI 75 and sPGA 0/1 responses at Week 16 and Week 24. Findings include:

PASI 75 Response in POETYK PSO-1 and POETYK PSO-2:

• At Week 16, 58.7% and 53.6% of patients receiving deucravacitinib achieved PASI 75 response, respectively, versus 12.7% and 9.4% receiving placebo and 35.1% and 40.2% receiving Otezla.
  
• At Week 24, 69.0% and 59.3% of patients receiving deucravacitinib achieved PASI 75 response, respectively, versus 38.1% and 37.8% receiving Otezla.
  
• Among patients who achieved PASI 75 response at Week 24 with deucravacitinib and continued treatment with deucravacitinib, 82.5% and 81.4%, respectively, maintained PASI 75 response at Week 52.
  

sPGA 0/1 Response in POETYK PSO-1 and POETYK PSO-2:

• At Week 16, 53.6% and 50.3% of patients receiving deucravacitinib achieved sPGA 0/1 response, respectively, versus 7.2% and 8.6% receiving placebo and 32.1% and 34.3% receiving Otezla.
  
• At Week 24, 58.4% and 50.4% of patients receiving deucravacitinib achieved sPGA 0/1 response, respectively, versus 31.0% and 29.5% receiving Otezla.
  

“In both pivotal studies, deucravacitinib was superior to Otezla across multiple endpoints, including measures of durability and maintenance of response, suggesting that deucravacitinib has the potential to become a new oral standard of care for patients who require systemic therapy and need a better oral option for their moderate to severe plaque psoriasis,” said April Armstrong, M.D., M.P.H., Associate Dean and Professor of Dermatology at the University of Southern California. “As many patients with moderate to severe plaque psoriasis remain undertreated or even untreated, it is also highly encouraging to see that deucravacitinib improved patient symptoms and outcomes to a greater extent than Otezla.”

Superiority of Deucravacitinib Versus Placebo and Otezla

Deucravacitinib demonstrated a robust efficacy profile, including superiority to placebo for the co-primary endpoints and to Otezla for key secondary endpoints. In addition to PASI 75 and sPGA 0/1 measures, deucravacitinib was superior to Otezla across both studies in multiple other secondary endpoints, demonstrating significant and clinically meaningful efficacy improvements in symptom burden and quality of life measures.

Deucravacitinib was well-tolerated and had a similar safety profile in both trials. At Week 16, 2.9% of 419 patients on placebo, 1.8% of 842 patients on deucravacitinib and 1.2% of 422 patients on Otezla experienced serious adverse events (SAEs) across both studies. The most common AEs (≥5%) with deucravacitinib treatment at Week 16 were nasopharyngitis and upper respiratory tract infection with low rates of headache, diarrhea and nausea. At Week 16, 3.8% of patients on placebo, 2.4% of patients on deucravacitinib and 5.2% of patients on Otezla experienced AEs leading to discontinuation. Across POETYK PSO-1 and POETYK PSO-2 over 52 weeks, SAEs when adjusted for exposure (exposure adjusted incidence per 100 patient-years [EAIR]) were 5.7 with placebo, 5.7 with deucravacitinib and 4.0 with Otezla. In the same timeframe across both studies, EAIRs for AEs leading to discontinuation were 9.4 with placebo, 4.4 with deucravacitinib and 11.6 with Otezla. No new safety signals were observed during Weeks 16‒52.

Across both Phase 3 trials, rates of malignancy, major adverse cardiovascular events (MACE), venous thromboembolism (VTE) and serious infections were low and generally consistent across active treatment groups. No clinically meaningful changes were observed in multiple laboratory parameters (including anemia, blood cells, lipids and liver enzymes) over 52 weeks.

“The findings from both studies affirm that deucravacitinib – a first-in-class, oral, selective TYK2 inhibitor with a unique mechanism of action that inhibits the IL-12, IL-23 and Type 1 IFN pathways –may become an oral treatment of choice for people living with psoriasis. We believe deucravacitinib has significant potential across a broad range of immune-mediated diseases, and we are committed to further advancing our expansive clinical program with this agent,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We are in discussions with health authorities with the goal of bringing this new therapy to appropriate patients as soon as possible. At Bristol Myers Squibb, we are committed to building an immunology portfolio that addresses pressing unmet needs that exist for those impacted by serious dermatologic conditions and other immune-mediated diseases, to ultimately deliver the promise of living a better life.”

Dermavant to Showcase PASI90, Itch and Quality of Life Data from Phase 3 Pivotal Trials for Tapinarof

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Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, will present data from its two pivotal Phase 3 trials for tapinarof for the treatment of psoriasis in adults, PSOARING 1 (tapinarof 1%, n=340; vehicle, n=170) and PSOARING 2 (tapinarof 1%, n=343; vehicle, n=172), at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021) on April 23-25, 2021.

The posters feature important secondary efficacy endpoints and patient-reported outcomes data from patients with mild, moderate, or severe chronic plaque psoriasis after 12 weeks of treatment with tapinarof cream 1% dosed once daily (QD) compared to vehicle QD.

Endpoints reported include ≥90% reduction in Psoriasis Area and Severity Index (PASI90) (an endpoint more commonly used in assessing systemic agents), itch reduction measured with the Peak Pruritis Numerical Rating Scale (PP-NRS), and improvement in quality of life as measured by the Dermatology Life Quality Index (DLQI). All secondary endpoints were met with highly statistically significant results, and patients treated with tapinarof showed significant improvement in all measures of disease activity included in the studies.

Highlights from Secondary Efficacy Endpoints and Patient-Reported Outcomes:

• PASI90 – At Week 12, a significantly higher proportion of patients treated with tapinarof cream 1%, QD achieved PASI90 in PSOARING 1 (18.8%) and PSOARING 2 (20.9%) compared to patients treated with vehicle in PSOARING 1 (1.6%; P=0.0005) and PSOARING 2 (2.5%; P<0.0001).
  

• ≥4-point Improvement in PP-NRS – Peak Pruritis-NRS – A statistically significant higher proportion of patients treated with tapinarof cream 1%, QD achieved at least a 4-point NRS improvement – a change that is considered clinically meaningful – at each time point from Week 2 through Week 12. At Week 12 in PSOARING 1 and PSOARING 2 that proportion was 67.5% and 59.7% respectively, compared to patients treated with vehicle (46.1% in PSOARING 1; P=0.0004, and 31.3% in PSOARING 2; P<0.0001).
  

• DLQI – At Week 4, patients treated with tapinarof cream, 1% QD reported significant improvements in quality of life as measured by the DLQI. A minimal clinically important difference of –4.0 in DLQI was exceeded at Week 12 for patients treated with tapinarof (–5.0 in PSOARING 1; –4.7 in PSOARING 2). These reductions were significant (both P<0.0001) compared to vehicle (–3.0 in PSOARING 1; –1.6 in PSOARING 2).
  

“It is encouraging to see Phase 3 secondary endpoints data like this from a topical,” said Linda Stein Gold, MD, Director of Dermatology Clinical Research at Henry Ford Health System. “Seeing the PASI90 scores for approximately one in five patients in the PSOARING pivotal trials makes me extremely excited for what tapinarof may mean as a treatment option for patients with psoriasis, if approved.”