Roflumilast Cream: Long-Term Safety & Efficacy in Children

For children aged 2 to 5 years with atopic dermatitis (AD), roflumilast cream 0.05% has a favorable long-term safety profile and efficacy for up to 56 weeks, according to a study published online March 8 in Pediatric Dermatology.

Lawrence F. Eichenfield, M.D., from the University of California-San Diego School of Medicine, and colleagues examined the long-term outcomes of continuing roflumilast cream for ≤56 weeks in a phase 3 open-label extension of the INTEGUMENT-PED trial (INTEGUMENT-OLE) conducted among children aged 2 to 5 years with mild-to-moderate AD. Roflumilast cream 0.05% was applied once daily in INTEGUMENT-OLE; application was switched to twice weekly in patients who achieved Validated Investigator Global Assessment for AD (vIGA-AD) clear (0) at/after week 4 of INTEGUMENT-OLE.

The researchers found that 14 (2.5%) of the 562 patients had treatment-related adverse events (AEs). Roflumilast was well tolerated; four patients (0.7%) reported application-site pain AEs. AD signs/symptoms continued to improve at treatment week 56 (63.1% of patients achieved vIGA-AD 0/1). The median duration of disease control was 238 days among the 170 patients (30.2%) who switched to twice-weekly application.

“Providing safe, effective nonsteroidal treatment options for young patients—who can have substantial disease burden but have limited available therapies—remains an important goal in pediatric dermatology,” Eichenfield said in a statement. “The publication of these data reinforces Zoryve cream 0.05% as a meaningful, long-term treatment option for children living with atopic dermatitis and their families.”

Several authors disclosed ties to biopharmaceutical companies, including Arcutis Biotherapeutics, which manufactures roflumilast and funded the study.

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