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Arcutis Announces Publication of ZORYVE® (roflumilast) Cream 0.15% Pivotal Results from Phase 3 INTEGUMENT-1 and -2 Trials in Mild to Moderate Atopic Dermatitis in Journal of American Medical Association Dermatology
ZORYVE® (roflumilast) cream 0.15% improved atopic dermatitis (AD) across multiple efficacy endpoints while demonstrating favorable safety and
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"ZORYVE® (roflumilast) cream 0.15% improved atopic dermatitis (AD) across multiple efficacy endpoints while demonstrating favorable safety and tolerabilityAcross both studies, approximately 31% of children and adults treated with ZORYVE cream achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success at Week 4 compared to 14% for vehicle, with significant improvement as early as Week 1ZORYVE cream 0.15% rapidly and significantly reduced itch, the most bothersome symptom of ADOnce-daily, ZORYVE cream 0.15% is approved to treat mild to moderate AD in adults and children down to age 6 WESTLAKE VILLAGE, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Journal of American Medical Association Dermatology (JAMA Dermatology) published the positive results from two pivotal Phase 3 studies (INTEGUMENT-1 and INTEGUMENT-2) evaluating the efficacy and safety of ZORYVE® (roflumilast) cream 0.15% as a once-daily, steroid-free treatment for mild to moderate AD. ZORYVE cream, 0.15%, was approved in July 2024 by the U.S. Food and Drug Administration (FDA) for the topical treatment of mild to moderate AD in adult and pediatric patients 6 years of age and older and is available in pharmacies nationwide. The article reported that treatment with ZORYVE cream resulted in significant improvements across multiple efficacy endpoints, including achieving a statistically significant improvement in the primary efficacy endpoint of IGA Success, as well as statistically significant improvements in key secondary endpoints, including itch and a reduction in Eczema Area and Severity Index score. “AD is a chronic and burdensome disease that often leaves patients and caregivers searching for relief from intractable itch, the most reported symptom which leads to reduced quality of life and sleep disturbances,” said Eric Simpson, MD, MCR, FAAD, Professor of Dermatology at Oregon Health & Science University in Portland and lead author on the publication. “These compelling results reinforce the strong efficacy and safety profile of ZORYVE and its ability to provide rapid and significant itch relief. Skin barrier is another key consideration for the treatment of AD, a...