On New Roflumilast Cream Data for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD

In a new HCPLive interview, Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children's Hospital–San Diego and lead author of the INTEGUMENT-OLE publication, highlighted the value of new long-term data supporting roflumilast cream .05% (ZORYVE) as a sustained treatment option for young children living with atopic dermatitis.1,2

Eichenfield opened by contextualizing the need for the open-label extension study. Although the earlier 4-week, phase 3 trial successfully demonstrated the drug’s safety and efficacy as a once-daily cream versus vehicle in children aged 2 - 5 years, Eichenfield described this short observation window as having inherent limitations, especially related to characterizing adverse events (AEs) and long-term tolerability.

In his discussion, Eichenfield underscored the unmet need for non-steroidal options in this population. Eichenfield later also noted young children with atopic dermatitis often present with high body surface area (BSA) involvement, even among those classified as mild-to-moderate, making a safe and sustained topical option especially helpful.

The INTEGUMENT-OLE trial had recruited 562 participants, all of whom had previously taken part in INTEGUMENT-PED, and treated them with once-daily roflumilast cream .05% as monotherapy. This would last for up to 52 weeks. Eichenfield highlighted the novel design element of the extension study, noting individuals attaining a complete level of skin clearance, defined as a vIGA-AD score of 0 at or after Week 4, were shifted to a proactive twice-weekly maintenance regimen.

He described this approach as generating "very interesting data" on long-term disease control, with Kaplan-Meier analysis ultimately estimating a median disease control duration of 238 days among those who entered the maintenance phase.

On the safety front, Eichenfield and colleagues found treatment-emergent adverse events in approximately half of participants, with the majority classified as mild or moderate. Serious adverse events occurred in 3.2% of children, though none were deemed treatment-related. Application-site tolerability was also favorable, with investigators reporting no signs of irritation in at least 97% of subjects throughout the study.

From an efficacy standpoint, these findings point to sustained and gradually improving responses over time. By the 56-week mark, 63.1% of those completing the extension showed a vIGA-AD score of clear or almost clear, and more than 70% across treatment arms achieved EASI-75. Eichenfield pointed to the findings as helpful within the broader context of pediatric dermatology, describing young patients as carrying a substantial disease burden while having access to relatively few approved medications.

The quotes used in this interview were edited for the purposes of clarity.

Disclosures: Eichenfield previously reported receiving personal fees from Pfizer Inc; grant funding from AbbVie, Arcutis Biotherapeutics, Bausch + Lomb, Castle Biosciences, Dermavant Sciences Inc, Galderma SA, Pfizer Inc, Regeneron, and Sanofi SA and consulting for ASLAN Pharmaceuticals, AbbVie, Almirall, SA, Arcutis Biotherapeutics, Arena Pharmaceuticals Inc, Dermavant Sciences Inc, Galderma SA, Incyte Corporation, LEO Pharma A/S, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, Regeneron Pharmaceuticals Inc, Sanofi SA, and UCB; and serving on the board of directors of Forté Pharma.

References

1. Smith T. New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children. HCPLive. March 10, 2026. Accessed March 16, 2026. https://www.hcplive.com/view/new-long-term-data-announced-roflumilast-cream-atopic-dermatitis-in-children.

2. Smith T. INTEGUMENT: Quality of Life with Roflumilast Cream (Zoryve) in Atopic Dermatitis. HCPLive. October 24, 2025. Accessed March 16, 2026. https://www.hcplive.com/view/integument-quality-of-life-roflumilast-cream-zoryve-atopic-dermatitis.