Arcutis Biotherapeutics’ roflumilast cream shows efficacy in atopic dermatitis

Arcutis Biotherapeutics announced interim results from the INTEGUMENT-OLE long-term open-label study of roflumilast cream 0.15% in adults and children ages 6 years and older with atopic dermatitis. In the study, roflumilast cream was well-tolerated, with no new safety signals observed during treatment up to 56 weeks in duration. Efficacy was not only maintained but improved over time, with 46.1% and 51.0% of participants who rolled over from the roflumilast cream treatment arm in INTEGUMENT-1 or -2 achieving validated Investigator Global Assessment-Atopic Dermatitis success. Additionally, in the study, 61.5% and 66.2% of participants who rolled over from the roflumilast cream arm in INTEGUMENT-1 or -2 demonstrated a 75% improvement from baseline in Eczema Area and Severity Index after 28 weeks and 56 weeks, respectively. The long-term study results reinforce the safety profile of roflumilast cream already seen in the short-term INTEGUMENT-1 and INTEGUMENT-2 clinical trials, with no new safety signals observed up to 56 weeks. 3.0% of trial participants discontinued the study due to adverse events. Arcutis intends to submit a supplemental New Drug Application late in Q3 for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis in individuals ages 6 years and older.