New INTEGUMENT-PED Results Support Roflumilast Cream for Pediatric AD

Arcutis Biotherapeutics announced today that the INTEGUMENT-PED Phase 3 trial had met its primary endpoint, according to a release from the manufacturer.

Researchers on the study evaluated the efficacy and safety of roflumilast cream 0.05% in children aged 2 to 5 with mild to moderate atopic dermatitis (AD). The trial met its primary endpoint, with 25.4% of participants achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) success at Week 4, compared to 10.7% in the vehicle group (P < 0.0001). vIGA-AD success was defined as a score of 'Clear' or 'Almost Clear' plus a 2-grade improvement from baseline. Secondary endpoints were also met and included a significant reduction in itch. Among children with a baseline Worst Itch Numeric Scale (WI-NRS) score of 4 or higher, 35.3% of those treated with roflumilast cream saw a four-point reduction at Week 4, compared to 18.0% in the vehicle group (nominal P = 0.0002).

The safety profile of roflumilast cream 0.05% was consistent with previous studies in older populations. The most common adverse events included upper respiratory tract infection, diarrhea, and vomiting.

“Results from the INTEGUMENT-PED trial demonstrate that ZORYVE cream 0.05% can quickly and reliably improve the symptoms of AD, especially itch," said Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego and lead author on the publication, said in a press release. "The publication of these results and the entire clinical development program highlight that ZORYVE cream 0.05%, if approved, could fill a significant gap in the current treatment landscape for a once-daily steroid-free topical therapy that is appropriate for both the short and long-term management of AD, key concerns for young patients and their caregivers.” 

Source: Arcutis press release. February 24, 2025.