Arcutis Announces New Long-Term Data of Roflumilast Cream 0.15% for the Treatment of Mild to Moderate Atopic Dermatitis (AD) in Adults and Children Down to Age Six Presented at Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference

Core Insights - Investigational roflumilast cream 0.15% demonstrated sustained improvements in atopic dermatitis (AD) symptoms over 56 weeks, including a 66.2% achievement rate of 75% improvement in Eczema Area and Severity Index (EASI-75) among participants [1][4] - The cream was well tolerated with no new safety signals observed during the study, reinforcing its safety profile [1][5] - The study supports the potential of roflumilast cream as a long-term, steroid-free treatment option for AD, emphasizing proactive disease management [3][6] Efficacy and Safety - 66.2% of participants treated with roflumilast cream achieved EASI-75 at Week 56, with 56.6% of those continuing from the initial trial and 53.8% switching from vehicle achieving validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success [1][4] - The median duration of disease control for participants switching to proactive twice-weekly application was 281 days, with 57.7% maintaining control through the study [2][4] - The overall incidence of adverse events was low, with most being mild to moderate, and only 3.0% of participants discontinued due to adverse events [5] Study Design and Objectives - The INTEGUMENT-OLE study was a Phase 3, multicenter, open-label extension evaluating the long-term safety of roflumilast cream in adults and children aged 6 years and older with AD [7][8] - The primary objective was to assess long-term safety, while secondary endpoints included vIGA-AD scores and EASI scores over time [8] Product Information - Roflumilast cream is a topical phosphodiesterase-4 (PDE4) inhibitor, currently under FDA review for the treatment of AD, with a target action date of July 7, 2024 [10] - The cream is formulated to be non-greasy and free from known allergens that may compromise skin barrier integrity, offering a steroid-free option for patients [6][10] Market Context - Atopic dermatitis affects approximately 9.6 million children and 16.5 million adults in the United States, highlighting the significant need for effective long-term treatments [9] - The results from the study may shift treatment paradigms from reactive management of flares to proactive long-term disease control [3][6]