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Arcutis Biotherapeutics, Inc. – Journal of the American Medical Association Publishes Roflumilast Cream 0.3% Results from Pivotal DERMIS-1 and -2 Phase 3 Trials in Plaque Psoriasis

WESTLAKE VILLAGEArcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immunodermatology, today announced that the Journal of the American Medical Association (JAMA) published positive results from two pivotal Phase 3 studies (DERMIS-1 and DERMIS-2) evaluating roflumilast cream 0.3% as a once-daily, topical treatment for chronic plaque psoriasis.

The study, which was published in the September 20 edition of JAMA, found that treatment with roflumilast cream resulted in significant improvements on multiple efficacy endpoints, including plaque clearance and pruritus at eight weeks in adults and adolescents with plaque psoriasis compared to vehicle. ZORYVE is approved for topical use of plaque psoriasis, including intertriginous psoriasis, for use in adults and adolescents in July 2022.

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‘These data highlight the robust efficacy of ZORYVE as a novel non-steroidal treatment option for individuals with plaque psoriasis. Both studies met the primary endpoint of IGA success and demonstrated rapid plaque clearance and reduction in itching,” said Patrick Burnett, MD, Ph.D., chief medical officer of Arcutis. “Combined with ZORYVE’s favorable safety and tolerability data, these results reinforce that ZORYVE can provide patients with a single topical therapy for use on all psoriasis-affected areas – including hard-to-treat areas such as elbows and knees and intertriginous areas. We are delighted that such a prestigious journal has published the results of our pivotal Phase 3 trials.”

‘The itching that can occur in patients with chronic plaque psoriasis has negative effects on a patient’s quality of life,’ said Mark Lebwohl MD., FAAD, Principal Investigator and Dean of Clinical Therapy and Chair Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai and a paid consultant and researcher for Arcutis. “The data from these studies showed that ZORYVE was effective in providing a rapid and significant reduction in itch as early as week two, and significantly improved itch-related sleep loss and Dermatology Life Quality Index scores (by week six). In addition, ZORYVE rapidly cleared plaques in patients with mild, moderate and severe disease, as well as in intertriginous areas.”

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The ‘Trials of PDE4 inhibition with Roflumilast for the Management of plaque Psoriasis’ One and Two (or DERMIS-1 and DERMIS-2) were identical, randomized, parallel, double-blind, vehicle-controlled, multinational, multi-center studies in which roflumilast 0.3 % cream or matching vehicle cream was applied once daily for eight weeks to subjects 2 years of age and older with mild, moderate, or severe chronic plaque psoriasis with between 2% and 20% body surface area. DERMIS-1 enrolled 439 subjects and DERMIS-2 enrolled 442 subjects.

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In both studies, significantly more patients treated with roflumilast cream achieved IGA success at week eight compared to the control group of vehicle-treated patients (DERMIS-1: 42.4% vs. 6.1%; DERMIS-2: respectively 37.5% vs 6.9% , P

(C) 2022 Electronic News Publishing, source ENP Newswire

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