- ZORYVE® (roflumilast) cream 0.15% improved atopic dermatitis (AD) across multiple efficacy endpoints while demonstrating favorable safety and tolerability
- Across 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 1
- ZORYVE cream 0.15% rapidly and significantly reduced itch, the most bothersome symptom of AD
- Once-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, and these data further demonstrate that ZORYVE may be relied upon to deliver results without concerns for further disrupting the skin barrier.”
INTEGUMENT-1 and INTEGUMENT-2 (The INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis) were two identical Phase 3, parallel group, double-blind, vehicle-controlled trials evaluating the safety and efficacy of ZORYVE cream 0.15% or vehicle applied once-daily for four weeks to 1,337 adults and children 6 years of age and older with mild to moderate AD.
As previously reported, both INTEGUMENT-1 and -2 studies met their primary endpoint of IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) score of Clear or Almost Clear plus a 2-grade improvement from baseline at Week 4 (INTEGUMENT-1: 32.0% ZORYVE cream vs. 15.2% vehicle, P