Arcutis Biotherapeutics, Inc. presented in a late-breaking clinical trial session at the American Academy of Dermatology (AAD) annual meeting (San Diego, CA, March 8 ? 12) 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 (P<0.0001), 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 (EASI-75) at Week 4 compared to 20.6% treated with vehicle (P<0.0001).

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 (0) or almost clear (1) compared to 14.6% of vehicle (P<0.0001) at the end of the study (Week 4), 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 (P=0.0014 vs vehicle). Roflumilast cream 0.05% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low, and the only adverse event occurring in =3% of subjects in either active- or vehicle-arm was upper respiratory tract infection.

The most frequent adverse events in the roflumilast arm (=2%) 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.