Arcutis announces results from INTEGUMENT-OLE study of roflumilast cream

Arcutis Biotherapeutics announced results from the INTEGUMENT-OLE long-term open-label study of once-daily roflumilast cream 0.05% demonstrating the durable efficacy and favorable safety profile of roflumilast cream 0.05% in the treatment of mild to moderate AD in children 2 to 5 years old. In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment of up to 56 weeks in duration. Efficacy was not only maintained but improved over time, with 71.9% of participants who rolled over from the roflumilast cream 0.05% treatment arm in INTEGUMENT-PED achieving 75% improvement from baseline in Eczema Area and Severity Index after 56 weeks. In the study, 53.8% of participants who rolled over from the roflumilast cream treatment arm in INTEGUMENT-PED achieved a validated Investigator Global Assessment-Atopic Dermatitis success, defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline, at 56 weeks. The long-term study results reinforce the safety and tolerability profile of roflumilast cream 0.05% already seen in the 4-week pivotal INTEGUMENT-PED clinical trial, with no new safety signals observed up to 56 weeks. Overall incidence of adverse events was low, with most being mild to moderate in nature. The most frequently reported adverse events included: upper respiratory tract infection, nasopharyngitis, pyrexia, influenza, COVID-19, and otitis media. Overall, only 3.0% of trial participants discontinued the study due to adverse events. Arcutis intends to submit an sNDA to the FDA in the first quarter of 2025 for roflumilast cream 0.05% for the treatment of AD in individuals ages 2-5 years. ZORYVE cream 0.15% is approved for the topical treatment of mild to moderate AD in adults and pediatric patients down to age 6.