Arcutis Biotherapeutics says INTEGUMENT-2 trial met primary, secondary endpoints

Arcutis Biotherapeutics announced topline results from its INTEGUMENT-2 pivotal Phase 3 trial of roflumilast cream 0.15%, a once-daily, non-steroidal topical phosphodiesterase-4 inhibitor, in adults and children 6 years and older with mild to moderate atopic dermatitis. The study met its primary endpoint, with 28.9% of individuals treated with roflumilast cream 0.15% achieving IGA Success, defined as a validated Investigator Global Assessment – Atopic Dermatitis score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 12.0% of individuals treated with vehicle. Roflumilast cream also demonstrated rapid and statistically significant improvements compared to vehicle on key secondary endpoints, including 42.0% of individuals treated with roflumilast cream 0.15% achieving a 75% improvement in Eczema Area and Severity Index at Week 4 compared to 19.7% treated with vehicle. In an additional secondary endpoint, the study evaluated reduction in itch in individuals 12 years of age and older, with 30.2% of individuals treated with roflumilast cream achieving a 4-point reduction in Worst Itch Numeric Scale at Week 4. Roflumilast cream 0.15% was well tolerated. The incidence of Treatment Emergent Adverse Events was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate severity. Overall, incidence of adverse events were low, with no adverse event occurring in more than 3.5% of subjects in either arm. The most frequent adverse events in the roflumilast arm included headache, nausea, vomiting, diarrhea, and upper respiratory tract infection. Over 90% of patients who were randomized to roflumilast cream in the study completed the full four weeks, and there were few discontinuations due to adverse events.