Long-Term Safety of Roflumilast Cream for Children, With Lawrence Eichenfield, MD

New long-term INTEGUMENT-OLE open-label extension trial data reinforce roflumilast cream .05% (ZORYVE) as a durable, well-tolerated non-steroidal medication for children aged 2 - 5 years living with atopic dermatitis, with efficacy continuing to build over the full 56-week study period.1,2

In the second half of his discussion with the team at HCPLive, Eichenfield, chief of pediatric and adolescent dermatology at Rady Children's Hospital–San Diego, highlighted what those new results could mean in practice and their significance among this patient population.

One of the most clinically notable observations from the extension study was that efficacy did not plateau after initial response. The continued to improve over time, and Eichenfield pointed to this trajectory as a reflection of the sustained anti-inflammatory action of roflumilast as a topical PDE4 inhibitor. While the earlier 4-week INTEGUMENT-PED trial established differentiation from vehicle, this longer observation window demonstated patients who had not yet attained clear or almost-clear status at the 4-week mark continued to improve as the drug’s use continued.

Even children who had been on vehicle in the initial trial and subsequently crossed over to active treatment caught up relatively quickly, Eichenfield highlighted. Beyond direct inflammation suppression, Eichenfield also described the mechanism as working to improve patients’ skin barriers and reducing their levels of pruritus. This effectively de-amplifyies the interconnected cycle of inflammation, dysfunction of barrier, and itch representing patients’ atopic dermatitis-related burdens.

On the question of tolerability, a heightened concern given the body surface area-to-weight ratio in toddlers and preschoolers, Eichenfield characterized these new findings as reassuring. More than 97% of those evaluated showed no evidence of local irritation at any evaluation point across the 56-week period, he noted, and caregiver-reported stinging or burning was documented in fewer than 1.8% of children at any single point in time.

Additionally, Eichenfield distinguished between tolerability and safety as distinct dimensions. He described, on the safety side, treatment-emergent adverse events, such as upper respiratory infections at 8.7%, pyrexia, and nasopharyngitis, as occurring at consistent rates with what is expected in any cohort of 2- to 5-year-olds followed over a full year. Eichenfield described serious adverse events as rare, noting a lack of such events being deemed treatment-related.

Contextualizing these data within the broader management landscape, Eichenfield pointed to this age group as having had historically very few approved non-steroidal medication options, while carrying a disproportionately high disease burden. He acknowledged concerns about topical corticosteroids, whether fully warranted or not, are a real-world driver of hesitancy among caregivers. Having a therapy designed for clinicians and families to use as needed with genuine comfort, Eichenfield argued, has the potential to meaningfully shift how well atopic dermatitis is controlled early in life.

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. Eichenfield L. On New Roflumilast Cream Data for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD. HCPLive. March 16, 2026. https://www.hcplive.com/view/on-new-roflumilast-cream-data-atopic-dermatitis-children-lawrence-eichenfield-md.