Arcutis Biotherapeutics announces new individual patient response data

Arcutis Biotherapeutics announced new individual patient response data showing the vast majority of individuals treated with investigational roflumilast cream 0.15% had a measurable improvement in Eczema Area and Severity Index in 4 weeks. New pooled analyses from two pivotal Phase 3 studies were presented at the 2024 Winter Clinical Dermatology Conference – Hawaii held January 12-17, 2024, in Honolulu, HI. Roflumilast cream 0.15% is a once-daily, steroid-free cream being investigated for adults and children 6 years of age and older with atopic dermatitis. At Week 4, a statistically significant greater percentage of patients achieved a 50% reduction in EASI scores, with 69.2% of patients treated with roflumilast cream compared to 44.4% of those treated with vehicle based on observed data. At the same 4-week endpoint, a 75% reduction in EASI scores was achieved in 44.5% of roflumilast-treated patients compared to 21.2% of vehicle-treated patients. Importantly, EASI-90 was observed in 22.4% of patients treated with roflumilast cream compared to 8.6% of vehicle-treated patients and a 100% reduction was observed in 9.8% of patients treated with roflumilast cream compared to 4.8% of vehicle-treated patients. Roflumilast cream 0.15% safety and tolerability data were comparable with vehicle, with low rates of application site adverse events, treatment-related AEs, and discontinuations due to AEs. INTEGUMENT-1 and INTEGUMENT-2 were two identical Phase 3, parallel group, double blind, vehicle-controlled trials evaluating the safety and efficacy of roflumilast cream 0.15% in AD.