- 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 2
- In both studies, roflumilast cream improved atopic dermatitis across multiple efficacy endpoints while demonstrating favorable safety and tolerability
- Incidences 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