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Arcutis Presents Late-Breaking Data from the INTEGUMENT Phase 3 Trials in Atopic Dermatitis at American Academy of Dermatology Annual Meeting
New INTEGUMENT-1 and INTEGUMENT-2 data show a rapid and significant reduction in itch as early as 24 hours after the first application of roflumilast cream
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"New INTEGUMENT-1 and INTEGUMENT-2 data show a rapid and significant reduction in itch as early as 24 hours after the first application of roflumilast cream 0.15%Rapid and significant improvements were achieved including individuals reaching a 75% reduction of Eczema Area and Severity Index (EASI-75) as early as Week 1 and in Investigator Global Assessment (IGA) Success as early as Week 2In both studies, roflumilast cream improved atopic dermatitis across multiple efficacy endpoints while demonstrating favorable safety and tolerabilityIncidences of adverse events were low, with no adverse event occurring in more than 3.5% of subjects in either arm WESTLAKE VILLAGE, Calif., March 18, 2023 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (New Orleans, LA, March 17-21) new data from its INTEGUMENT-1 and INTEGUMENT-2 pivotal Phase 3 studies of roflumilast cream 0.15% in adults and children 6 years and older with mild to moderate atopic dermatitis (AD). Roflumilast cream is a once-daily, steroid-free topical formulation of a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor. Both studies met the 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% roflumilast cream vs. 15.2% vehicle, P","length":2252,"tagName":"div"}]