Arcutis Biotherapeutics eczema treatment cream Roflumilast met primary endpoints

Arcutis Biotherapeutics announced that the INTEGUMENT-PED pivotal Phase 3 trial of roflumilast cream 0.05%, in children ages 2 to 5 years with mild to moderate atopic dermatitis (AD) met its primary endpoint and all secondary endpoints. In the study, 25.4% of children using roflumilast cream 0.05% achieved skin improvement by Week 4, compared to 10.7% in the control group. Improvement was noticeable as early as Week 1.

Roflumilast cream 0.05% is a once-daily steroid-free topical cream in development, that is formulated to deliver drug without disrupting the skin barrier. INTEGUMENT-PED enrolled 652 children ages 2 to 5, with a mean Body Surface Area (BSA) of 22% overall, and a range from 3% to 82%. The data reinforce the well-established efficacy, safety and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program.

The “INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis in PEDiatric patients” (INTEGUMENT-PED) is a Phase 3, parallel group, double blind, vehicle-controlled trial in which roflumilast cream 0.05% or vehicle was applied once daily for four weeks to children 2 to 5 years of age with mild to moderate AD. A total of 652 children were enrolled in the study.

Incidence of adverse events (AEs) during the trial was low, with the most common AEs in the roflumilast cream treated arm (≥ 2%) being upper respiratory tract infection, pyrexia, diarrhea, and vomiting.