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Arcutis Presents New Data on Once-Daily Roflumilast Cream for Plaque Psoriasis from DERMIS Phase 3 Trials at American Academy of Dermatology Annual Meeting
Pooled analysis of DERMIS-1 and DERMIS-2 demonstrated significantly more roflumilast-treated patients achieved Investigator Global Assessment (IGA) success
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"Pooled analysis of DERMIS-1 and DERMIS-2 demonstrated significantly more roflumilast-treated patients achieved Investigator Global Assessment (IGA) success (40%) at week 8 compared to vehicle (7%), consistent with results from the individual studiesNew post hoc analyses showed consistent efficacy regardless of baseline body surface area (BSA) and efficacy in psoriasis patients with knee and/or elbow involvementInterim results from an ongoing Phase 3 open-label, long-term study supports the previously established long-term safety profile and demonstrated efficacy of topical roflumilast was maintained through 32 weeks WESTLAKE VILLAGE, Calif., March 25, 2022 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing meaningful innovations in immunodermatology, today announced new pooled results from the DERMIS Phase 3 trials of roflumilast cream are available in four abstracts at the 2022 American Academy of Dermatology annual meeting, taking place in Boston, MA. Roflumilast is a selective and highly potent phosphodiesterase-4 inhibitor (PDE4) being investigated by Arcutis as a non-steroidal topical treatment for multiple inflammatory skin diseases, including plaque psoriasis. “These data demonstrate the consistent efficacy of investigational roflumilast cream, in steroid sensitive areas, as well as hard-to-treat areas, such as knees and elbows, and regardless of disease severity. In addition, both patients and healthcare providers reported favorable local tolerability,” said Mark Lebwohl, MD, Dean of Clinical Therapeutics and Professor of Dermatology, Mount Sinai. “These findings are important because the majority of plaque psoriasis patients use topical treatments today. Roflumilast cream, if approved, could provide an important new topical therapy option for the millions of patients with chronic plaque psoriasis.” Pooled efficacy and safety results from the DERMIS-1 and DERMIS-2 Phase 3 trials showed that at week 8, 40% of patients treated with roflumilast cream achieved IGA success – the achievement of clear or almost clear plus a ≥2 grade improvement from baseline – compared to 7% of patients with vehicle (P","length":2829,"tagName":"div"}]