Overview

• The approval is supported by the phase 3 INTEGUMENT-PED trial, a phase 1 pharmacokinetic study, and a 56-week open-label extension, according to the company.
• At week 4 in INTEGUMENT-PED, 25.4% of children on roflumilast achieved clear or almost clear skin vs 10.7% with vehicle, and 39.4% reached EASI-75 vs 20%.
• Itch relief was observed quickly, beginning within 24 hours, with more children achieving a four-point itch reduction on roflumilast than on vehicle.
• Safety in young children aligned with adult data, with low rates of treatment-emergent adverse events and fewer than 1% reporting application-site discomfort.
• In the extension study, participants who shifted to proactive twice-weekly maintenance saw a median of 238 days of disease control; Arcutis says the cream is expected to be available by late October.