- Roflumilast cream showed higher efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of Investigator Global Assessment (IGA) success, with 40% of roflumilast cream treated patients achieving IGA success at eight weeks
- Roflumilast cream also demonstrated statistically significant improvements over vehicle in key secondary endpoints with ~70% of patients achieving Intertriginous-IGA success and ~40% of patients achieving PASI-75 at eight weeks
- Improvement in itch occurred as early as two weeks and improved consistently through week eight
- Once-daily ZORYVE™(roflumilast) is approved for topical use in adults and adolescents with plaque psoriasis, including intertriginous psoriasis, regardless of disease severity
WESTLAKE VILLAGE, Calif., Sept. 20, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early-stage commercial company focused on developing meaningful innovations in immuno-dermatology, 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 issue of JAMA, found that treatment with roflumilast cream resulted in significant improvements across multiple efficacy endpoints including plaque clearance and itch at eight weeks in adults and adolescents with plaque psoriasis compared to vehicle. ZORYVE was approved for topical use of plaque psoriasis, including intertriginous psoriasis, for use in adults and adolescents in July 2022.
“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 clearance of plaques and reduction of itch,” said Patrick Burnett, M.D., Ph.D., Chief Medical Officer of Arcutis. “Coupled with ZORYVE’s favorable safety and tolerability data, these results reinforce that ZORYVE can offer patients 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 thrilled that such a prestigious journal has published the results of our pivotal Phase 3 trials.”
“The itch that can occur in patients with chronic plaque psoriasis has negative effects on a patients' quality of life,” said Mark Lebwohl M.D., FAAD, principal investigator and Dean for Clinical Therapeutics and Chairman 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 investigator for Arcutis. “The data from these studies demonstrated 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 scores on the Dermatology Life Quality Index (by week six). In addition, ZORYVE rapidly cleared plaques in patients with mild, moderate, and severe disease, as well as in intertriginous areas.”
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 eight 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.
In both studies, significantly more patients treated with roflumilast cream reached IGA Success at week eight compared to the control group of vehicle-treated patients (DERMIS-1: 42.4% vs 6.1%; DERMIS-2: 37.5% vs. 6.9%, respectively, P