- Investigational roflumilast cream 0.15% showed continued improvements in the signs and symptoms of AD, including itch, through 56 weeks of treatment
- 66.2% of participants treated with once-daily roflumilast cream 0.15% in both the 4-week parent study and the 52-week open label extension achieved a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 56
- For participants who achieved disease clearance and switched to proactive twice weekly application of roflumilast cream, the median duration of disease control was 281 days
- Once-daily, roflumilast cream 0.15% was well tolerated, with no new safety signals observed for up to 56 weeks of treatment
CHICAGO and WESTLAKE VILLAGE, Calif., June 10, 2024 (GLOBE NEWSWIRE) — Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced new results from the INTEGUMENT-OLE long-term open-label study of investigational once-daily roflumilast cream 0.15% in adults and children ages 6 years and older with AD presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference. In the study, roflumilast cream was well-tolerated, with no new safety signals observed over 56 weeks of treatment. Efficacy was not only maintained but improved over time, with 56.6% of participants who continued use of roflumilast cream from the initial trial and 53.8% of participants who switched to roflumilast cream 0.15% from vehicle after the initial trial achieving validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success, defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, at Week 56.
