Arcutis presents late-breaking data from INTEGUMENT-PED Phase 3 trial

Arcutis Biotherapeutics presented in a late-breaking clinical trial session at the American Academy of Dermatology annual meeting new data from its INTEGUMENT-PED pivotal Phase 3 study of investigational roflumilast cream 0.05% in children 2 to 5 years of age with mild to moderate atopic dermatitis. The study found that treatment with once-daily, steroid-free roflumilast cream 0.05% resulted in significant improvements in atopic dermatitis across multiple efficacy endpoints and all timepoints, including disease clearance as early as Week 1 and reduction in itch in the first 24 hours following application. Results showed 25.4% of children treated with roflumilast cream 0.05% achieved the primary endpoint of IGA Success, defined as vIGA-AD score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4, compared to 10.7% treated with the vehicle, with significant improvements also seen at Week 1 and Week 2. In the study, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI at Week 4 compared to 20.6% treated with vehicle. Roflumilast cream is an investigational once-daily, steroid-free topical cream formulated to deliver drug without disrupting the skin barrier. INTEGUMENT-PED enrolled 652 children ages 2 to 5, with a mean Body Surface Area of 22% overall, and a range from 3% to 82%. The data reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program. New data highlighted in the session included 35.4% of children treated with roflumilast cream achieved vIGA-AD clear or almost clear compared to 14.6% of vehicle at the end of the study, with improvements seen as early as Week 1. In addition, the data show improvement in itch with roflumilast cream 0.05% as early as 24 hours following first application, based on LS mean change from baseline in daily WI-NRS score. Roflumilast cream 0.05% was well tolerated. The incidence of Treatment Emergent Adverse Events was low, and the only adverse event occurring in greater than or equal to 3% of subjects in either active- or vehicle-arm was upper respiratory tract infection. The most frequent adverse events in the roflumilast arm included pyrexia, diarrhea, and vomiting. Local tolerability was also favorable, with application site pain only being reported in 1.6% of roflumilast-treated participants vs.1.9% for the vehicle.