Monthly Archives: February 2021

Chalk another one up for Bristol Myers Squibbs psoriasis drugthe TYK2 inhibitor outshone placebo and Amgens Otezla in a second phase 3 study, teeing up discussions with regulators.

The study, known as POETYK PSO-2, tested the drug, deucravacitinib, against placebo and Otezla in 1,020 patients with moderate to severe plaque psoriasis, the company said in a statement. After 16 weeks of treatment, significantly more patients taking Bristol Myers drug than placebo had a 75% reduction of psoriasis area and severity and clear or almost clear skin as measured by the static Physicians Global Assessment, a visual assessment of psoriasis.

In addition to meeting these co-primary endpoints, deucravacitinib also beat Otezla on these measures, hitting key secondary endpoints.

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RELATED: Bristol Myers' psoriasis drug beats Amgen rival in phase 3

The company reported the results in broad strokes with plans to present detailed data at a future medical meeting. The news comes three months after Bristol Myers reported a similar performance in the 666-patient POETYK PSO-1 study, in which deucravacitinib also outperformed placebo and Otezla.

The superior efficacy we have observed in patients with moderate to severe psoriasis, combined with the well-tolerated safety profile, are consistent with the novel mechanism of action of deucravacitinib, a potential new class of molecule, said Samit Hirawat, M.D., chief medical officer of Bristol Myers Squibb.

Deucravacitinib works by blocking TYK2, an enzyme involved in the IL-12, IL-12 and type 1 IFN pathways, which play a role in psoriasis and other immune-mediated diseases. Bristol Myers is developing the drug for psoriatic arthritis, lupus and inflammatory bowel disease.

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Bristol Myers' psoriasis drug strikes again, beating Amgen's Otezla in a 2nd pivotal trial - FierceBiotech

TUESDAY, Feb. 2, 2021 (HealthDay News) -- Skin infections in the first two years of life are associated with pediatric psoriasis, according to a study recently published in the Journal of the American Academy of Dermatology.

Yi-Ju Chen, M.D., Ph.D., from Taichung Veterans General Hospital in Taipei, Taiwan, and colleagues conducted a nationwide nested case-control study to examine the impact of infantile infection and antibiotic exposure on pediatric psoriasis development. A total of 1,527 patients with pediatric psoriasis were identified and matched with 15,270 control individuals without psoriasis.

The researchers found that in both groups, the mean age was 9.9 3.7 years. In a multivariate analysis, independent associations with pediatric psoriasis were seen for atopic dermatitis (adjusted odds ratio, 2.07) and a family history of psoriasis, especially for the mother (adjusted odds ratio, 9.86) or other first-degree relatives (adjusted odds ratio, 5.49). Significant associations with pediatric psoriasis were seen for skin viral and bacterial infections (adjusted odds ratio, 1.35) and fungal infections (adjusted odds ratio, 1.71) in the first two years of life. No correlation was seen for systemic antibiotic exposure.

"Our results suggest that skin and fungal infections in early life are associated with pediatric psoriasis development," the authors write. "The role of early-life microbiota dysbiosis in the pathogenesis of pediatric psoriasis might be worth further investigation."

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Skin Infections in Early Childhood Linked to Pediatric Psoriasis - HealthDay News

WESTLAKE VILLAGE, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a medical dermatology company developing innovative treatments for patients with immune-mediated dermatological diseases and conditions, today announced positive topline results from the DERMIS-1 and DERMIS-2 pivotal Phase 3 studies evaluating roflumilast cream (ARQ-151) as a potential topical treatment for plaque psoriasis. Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor (PDE4).

On the studies primary endpoint of Investigator Global Assessment (IGA) Success at week 8, roflumilast cream 0.3% had an IGA Success rate in DERMIS-1 of 42.4% compared to a vehicle rate of 6.1% (P<0.0001), and in DERMIS-2 an IGA Success rate of 37.5% compared to a vehicle rate of 6.9% (P<0.0001). IGA Success was defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline. Roflumilast cream 0.3% also demonstrated statistically significant improvements over vehicle on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD).

In DERMIS-1 and DERMIS-2, roflumilast cream was generally safe and well-tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate in severity. Overall, 90% of patients who were randomized to roflumilast cream in the studies completed the full 8 weeks. Among subjects receiving roflumilast cream, there were only 5 discontinuations in DERMIS-1 due to a TEAE (1.7% of subjects) and 1 discontinution in DERMIS-2 due to TEAE (0.3% of subjects), and there were no treatment-related Serious Adverse Events (SAEs).

We are delighted with the strength of these Phase 3 data, which surpassed the already positive results we saw in our Phase 2 studies, said Patrick Burnett, M.D., Ph.D., FAAD, Arcutis Chief Medical Officer. These data reinforce our conviction that topical roflumilast is exceptionally well suited to address the unmet needs in the topical treatment of psoriasis, offering an ideal combination of efficacy comparable to the results of published clinical studies of high-potency steroid/calcipotriene or high-potency steroid/tazarotene combination products, the ability to use the drug chronically in any anatomical area, and a very favorable safety and tolerability profile. Based on the strength of these Phase 3 data, we anticipate submission of our NDA to the U.S. FDA in the second half of 2021. Importantly, we want to express our appreciation to the trial participants and the clinical investigators for their commitment to this important research effort.

The impact of plaque psoriasis extends beyond the serious physical burdens of the disease, with many patients experiencing adverse psychological and social effects as well, said Mark Lebwohl, MD, Professor and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and participant in the trial. The existing topical treatments prescribed to psoriasis patients have significant shortcomings, which lead to difficult trade-offs between efficacy, safety, and tolerability. These data demonstrate once-daily topical roflumilast cream was well-tolerated and achieved early and significant improvements in psoriasis signs and symptoms, including having a profound impact on itch.

The Trials of PDE4 inhibition with Roflumilast for the Management of plaque PsoriasIS One and Two (or DERMIS-1 and DERMIS-2) were identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which roflumilast 0.3% cream or matching vehicle cream were applied once daily for 8 weeks to subjects age 2 years and above with mild, moderate or severe chronic plaque psoriasis involving between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects, and DERMIS-2 enrolled 442 subjects. The primary endpoint of the studies was IGA Success at week 8. Multiple secondary endpoints were also evaluated, including I-IGA Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the WI-NRS and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). The Company anticipates submission of its NDA to the FDA in the second half of 2021.

Management will host a conference call today at 8:30 a.m. EST to discuss these results. To access the call, please dial (833) 614-1393 (domestic) or (914) 987-7114 (international) prior to the scheduled conference call time and provide the conference ID 8079585. A live webcast of the call will be available on the "Investors" section of the company's website, http://www.arcutis.com. An archived version of the webcast will be available on the Arcutis website after the call.

About PsoriasisPsoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the United States. About 90% of patients develop plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale. Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful. Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae and inframammary areas.

About Topical Roflumilast Cream

Roflumilast Cream is a topical cream formulation of a highly potent and selective PDE4 inhibitor (roflumilast). Roflumilast has been approved by the U.S. Food and Drug Administration (FDA) for oral treatment to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD) since 2011. Roflumilast has shown greater potency (25- to 300-fold) than the two other FDA-approved PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD. PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis or the systemic treatment of plaque psoriasis.

About Arcutis - Bioscience, applied to the skin.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. The Company is leveraging recent advances in immunology and inflammation to develop differentiated therapies against biologically validated targets to solve persistent treatment challenges in serious diseases of the skin. Arcutis robust pipeline includes four novel drug candidates currently in development for a range of inflammatory dermatological conditions. The Companys lead product candidate, topical roflumilast, has the potential to become the standard of care for plaque psoriasis, atopic dermatitis, scalp psoriasis, and seborrheic dermatitis. For more information, visit http://www.arcutis.com or follow the company on LinkedIn and Twitter.

Forward Looking StatementsThis press release contains "forward-looking" statements, including, among others, statements regarding roflumilast creams potential as a treatment for plaque psoriasis; and expectations with regard to the timing of potential NDA submission in 2021. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the "Risk Factors" section of our Form 10-Q filed with U.S. Securities and Exchange Commission (SEC) on November 5, 2020, as well as any subsequent filings with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Investors and Media:Heather Rowe ArmstrongVice President, Investor Relations & Corporate Communicationsharmstrong@arcutis.com805-418-5006, Ext. 740

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Arcutis Announces Positive Topline Results from Pivotal DERMIS-1 and -2 Phase 3 Trials of Topical Roflumilast Cream (ARQ-151) in Plaque Psoriasis -...

Psoriasis is a chronic skin condition that causes red, itchy patches or bumps on the skin. It can develop anywhere on the body, including the genitals. About 63% of adults with psoriasis may experience genital psoriasis at least once in their lifetime.

"Genital psoriasis can occur anywhere on the genitals, but the tip of the penis and in folds of skin are the most common locations," says Jeffrey M. Cohen, MD, assistant professor of dermatology at Yale School of Medicine. It can also affect the crease between the buttocks, skin above the genitals, and inner and upper thigh areas.

There are many ways to treat genital psoriasis, but mild topical corticosteroids are the first line of treatment. Here's how you can recognize, treat, and avoid irritating genital psoriasis.

Genital psoriasis is a form of inverse psoriasis, which commonly occurs in skin folds such as the underarms, under the breasts, and around the genital area.

"[It] generally presents as pink somewhat raised areas. Sometimes, these can be scaly, and other times, they may not be. The spots tend to be itchy, but they can also feel irritated," says Cohen.

Thick, scaly patches called plaques can also appear on the affected area, which are either red with silvery or white buildup (for lighter skin tones) or purple, gray, or dark brown (for darker skin tones). You may experience discomfort, pain, itching, and cracking of the skin.

Treatments for psoriasis vary from one person to another, and some individuals might need a combination of treatments to reduce their symptoms.

Important: Almost 50% of genital psoriasis patients don't discuss symptoms with their physicians due to shyness and fear of judgment, which may result in undertreatment. Genital psoriasis is common in psoriasis patients and is nothing to be ashamed of.

"Studies have shown that for many patients, genital psoriasis interferes with their sex lives, for reasons such as embarrassment or discomfort, but there is no health risk (for either partner) if someone with genital psoriasis has sex," says Cohen.

Genital psoriasis might also be mistaken for eczema or fungal infection. "It is important to note that several skin conditions can look quite similar in the genital region, and a diagnosis of genital psoriasis should be made by a board-certified dermatologist," says Cohen.

Psoriasis develops due to an overreaction of the body's immune response, which causes inflammation. As a result, new skin cells grow too fast and move to the surface, manifesting in reddish and itchy bumps.

Here are some tips to avoid irritation and further discomfort from genital psoriasis:

"Scratching or touching psoriasis cannot cause it to spread from one part of the body to another. It is also important to note that psoriasis is not at all contagious to others," says Cohen.

There are plenty of treatment plans for genital psoriasis, and what works for one person might not work for another. Although it is a chronic condition that reduces the quality of life, proper treatment can improve it.

About 70% to 80% of cases of psoriasis are mild, requiring only topical treatments. They can come in the form of corticosteroids, which are creams and ointments that reduce inflammation when applied to the skin, or nonsteroidal agents, medications that don't contain or are not steroids, like calcineurin inhibitors that suppress the immune system and reduce symptoms.

Biologics, or medications that target specific parts of the immune system, can be very effective for many types of psoriasis and generally come in the form of a pill, injection, or intravenous infusion. "Good moisturizers, such as Vaseline, are also helpful for patients with genital psoriasis," says Cohen.

Psoriasis doesn't go away and is present for someone's entire life. "However, some people experience long periods of time when psoriasis is not active," says Cohen. Following a treatment plan closely can reduce symptoms and avoiding certain irritants can help improve your genital psoriasis.

Genital psoriasis is a chronic skin condition that can develop anywhere on the genitals, buttocks, and thigh areas. Symptoms include red and itchy patches of skin that may or may not be scaly.

To avoid discomfort and irritation, moisturize the affected area and wear breathable underwear. Genital psoriasis is treated with topical medications and biologics (aka medications that target the cause of psoriasis), so talk to your healthcare provider to discuss the best treatment plan for you.

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Genital psoriasis: Signs, symptoms, and treatment options - Insider - INSIDER

Beata Kowalewska,1 Barbara Jankowiak,1 Mateusz Cybulski,1 Elbieta Krajewska-Kuak,1 Dzmitry Fiodaravich Khvorik2

1Department of Integrated Medical Care, Medical University of Bialystok, Bialystok, Poland; 2Department of Dermatovenerology, Medical University in Grodno, Grodno, Belarus

Correspondence: Beata KowalewskaDepartment of Integrated Medical Care, Medical University of Bialystok, 7A Curie-Skodowskiej Str., Bialystok, 15-096, PolandTel +48 85 748 55 28Email beata.kowalewska@umb.edu.pl

Introduction: Psoriasis is a chronic inflammatory disease of the skin having a profound effect on the quality of life and contributing to the sense of stigmatization in the affected patients. The aim of this study was to analyze the effect of psoriasis severity on the quality of life and sense of stigmatization in psoriatics and to investigate relationships between these measures and sociodemographic variables.Patients and Methods: The study included 111 patients with psoriasis. The inclusion criteria of the study were the diagnosis of psoriasis and written informed consent to participate. The study was based on a short survey prepared by the authors and four validated scales: Dermatology Life Quality Index (DLQI), 6-item Stigmatization Scale, 33-item Feelings of Stigmatization Questionnaire, and Psoriasis Area and Severity Index (PASI).Results: Mean PASI score for the study group was 14 pts. Most respondents presented with low DLQI scores, with the mean value of 10.8 pts suggesting that the disease-related ailments were not extremely burdensome for the majority of the patients. Mean stigmatization scores for the 6- and 33-item scale were 7 8 and 81 82 pts, respectively.Conclusion: The severity of psoriasis was the strongest determinant of the quality of life measured with the DLQI. Also, the levels of stigmatization determined with the 6- and 33-item scale correlated significantly with PASI scores.

Keywords: psoriasis, quality of life, stigmatization, psoriasis severity, psychodermatology, DLQI, PASI

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Effect of Disease Severity on the Quality of Life and Sense of Stigmat | CCID - Dove Medical Press