Business
Journal of the American Medical Association Publishes Roflumilast Cream 0.3% Results from Pivotal DERMIS-1 and -2 Phase 3 Trials in Plaque Psoriasis
Roflumilast cream showed higher efficacy compared to vehicle in both Phase 3 studies on the primary efficacy endpoint of Investigator Global Assessment (IGA)
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"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 weeksRoflumilast 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 weeksImprovement in itch occurred as early as two weeks and improved consistently through week eightOnce-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 c...