Long-Term Roflumilast Cream Shows Sustained Efficacy in Pediatric Atopic Dermatitis

Key Takeaways: 

• 71.9% of children treated with roflumilast cream 0.05% achieved EASI-75 at 56 weeks.
• No new safety signals were reported, with most adverse events being mild to moderate.
• Arcutis plans to submit an sNDA to the FDA in early 2025 to expand the cream's use to younger children.

A recent open-label extension study showed more than 70% of pediatric patients aged 2-5 years treated with roflumilast cream 0.05% achieved EASI-75 after 56 weeks of treatment, with sustained efficacy and favorable safety in managing atopic dermatitis (AD).

The INTEGUMENT-OLE study included participants who had completed the Phase 3 INTEGUMENT-PED trial. The long-term data not only reaffirmed the durable efficacy of the treatment, according to Arcutis Biotherapeutics in their news release, but also confirmed the absence of new safety concerns. The most common adverse events were mild to moderate and included upper respiratory tract infections, nasopharyngitis, and fever.

Dr. Adelaide Hebert, a trial investigator and a professor of dermatology and pediatrics at UTHealth Houston, emphasized the importance of the data.

“When choosing a therapy for very young children, health care providers and caregivers are looking for treatments that provide both rapid relief and are well-tolerated and suitable for long-term use,” she said in a press release. “These results build upon the findings from the Phase 3 trial, showing continued improvement over the long term."

Arcutis plans to submit a supplemental New Drug Application (sNDA) to the FDA in early 2025 for expanded use of roflumilast cream 0.05% for children down to age 2. 

Source: Arcutis press release. August 30, 2024.