Findings on Roflumilast Cream 0.05% for Children with Atopic Dermatitis, with Mercedes Gonzalez, MD

After Arcutis’s announcement that the US Food and Drug Administration (FDA) had accepted their supplemental New Drug Application (sNDA) for roflumilast cream 0.05% (Zoryve) as a topical for children with mild to moderate atopic dermatitis, the HCPLive team spoke with a clinical trial investigator for the INTEGUMENT-PED study.1

Mercedes E. Gonzalez, MD, is a clinical assistant professor at the FIU Herbert Wertheim School of Medicine and the Phillip Frost Department of Dermatology at the Miller School of Medicine. Gonzalez spoke with the HCPLive team about roflumilast’s recent data and its use as a once-daily topical phosphodiesterase-4 (PDE4) inhibitor in children aged 2 - 5 years.

“This was a pediatric atopic dermatitis that included patients 2 years to 5 years of age who had mild to moderate atopic dermatitis and had to have at least 3% body surface area to be enrolled in the trial,” Gonzalez said. “This was a 4-week trial. It was a randomized, placebo-controlled trial. Patients were randomized 2 to 1 to receive roflumilast 5% cream versus a vehicle, and they were followed for 4 weeks. The primary efficacy endpoint was IGA improvement. So this was an improvement in IGA score of 0 or 1, as well as an EASI 75 at 4 weeks.”

The findings highlighted by Gonzalez represented the conclusion of the INTEGUMENT-PED study, during which the research team followed up the INTEGUMENT-1 and INTEGUMENT-2 phase 3 analyses.2 437 subjects were included in the trial who were given roflumilast cream and 215 were in the vehicle arm.2

Gonzalez’s team highlighte that at the 4-week mark, there was a significantly higher proportion of individuals included in the roflumilast cream cohort who had visibly attained an EASI-75 (39.4% versus 20.6%; P < .0001), as well as Validated Investigator Global Assessment for atopic dermatitis (vIGA-AD) Success (25.4% versus 10.7%; P < .0001) and Worst Itch-Numeric Rating Score (WI-NRS) Success (35.3% versus 18.0%; nominal P = .0002).2

“Because of the data, I'm able to say that there's a significant chance that itch is going to improve quickly and that the skin lesions are going to go away pretty quickly within that 4-week time frame,” Gonzalez explained. “In addition, it does not have the side effects associated with the traditional topical corticosteroids. The rates of adverse events in the trial were extremely low, with less than 1% reporting stinging and burning from this medication. So that's important.”

It has been noted previously that the FDA has a PDUFA target action date set for October 13, 2025 for the roflumilast cream 0.05% application.1 For more information on this subject, view the full interview video posted above.

The quotes contained in this interview summary were edited for clarity.

References

1. Arcutis Biotherapeutics. U.S. FDA accepts Supplemental New Drug Application For Arcutis’ ZORYVE® (roflumilast) cream 0.05% for the treatment of children aged 2 to 5 with mild to moderate atopic dermatitis. Arcutis Biotherapeutics. February 26, 2025. Accessed February 26, 2025. https://www.arcutis.com/u-s-fda-accepts-supplemental-new-drug-application-for-arcutis-zoryve-roflumilast-cream-0-05-for-the-treatment-of-children-aged-2-to-5-with-mild-to-moderate-atopic-dermatitis/.

2. Eichenfield, L.F., Serrao, R., Berk, D.R., et al (2025). Efficacy and Safety of Once-Daily Roflumilast Cream 0.05% in Pediatric Patients Aged 2–5 Years With Mild-to-Moderate Atopic Dermatitis (INTEGUMENT-PED): A Phase 3 Randomized Controlled Trial. Pediatric Dermatology. https://doi.org/10.1111/pde.15840.