Tolerability of Roflumilast Cream 0.05% in Children with Eczema, With Lawrence Eichenfield, MD

Lawrence F. Eichenfield, MD, of Rady Children’s Hospital, spoke in another segment of his HCPLive interview on recent long-term safety and tolerability data drawn from the INTEGUMENT-OLE study, reflecting on what roflumilast cream .05% (Zoryve) could be for toddlers and preschoolers with atopic dermatitis.1,2

These findings were poster data presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting. Building on the efficacy findings established in the INTEGUMENT-PED pivotal trial and the phase 2 INTEGUMENT-INFANT data presented at this year's meeting, Eichenfield turned in the second part of his conversation with HCPLive to address these new data from INTEGUMENT-OLE.

Eichenfield was careful to distinguish between 2 related but separate concepts. Tolerability, as he framed it, is the day-to-day experience of using this topical agent, whether it burns, stings, or leads to application site reactions resulting in cessation.

Safety is the broader question of whether accumulated use over time produces immunosuppression or other systemic impacts. On both of these subjects, Eichenfield said, the INTEGUMENT-OLE open-label extension study provided reassuring answers. More than 97% of participants showed no evidence of local irritation at any assessment point across the 56-week study period.

“They also asked the caretakers about reports of stinging or burning at each visit, and it was less than 1.8% of participants at any time point who, over that 56 week time period, had problems with tolerability,” Eichenfield said.

On the safety side, treatment-emergent adverse events (AEs) taking place at rates of 4% or higher were consistent with what clinicians expect in any cohort of 2- to 5-year-olds followed over a full year. Specifically, there were upper respiratory infections at a rate of 8.7%, some nasopharyngitis, some fever, and a small number of gastrointestinal events.

None of AEs, Eichenfield added, were signals attributable to the drug. Serious adverse events were rare, and those viewed as treatment-related were minimal. When asked how roflumilast cream fits within the overall management landscape for this age cohort, Eichenfield acknowledged concerns over topical corticosteroids among caregivers may be higher than ever, whether or not this view is always warranted.

This creates a practical need for a non-steroidal option for families to use with confidence, Eichenfield added. He also pointed to the INTEGUMENT-INFANT data as the next frontier for this research into roflumilast, describing the evidence base as now extending to children under 2, a group where the unmet need is even more acute and where the availability of a safe, effective non-steroidal option would be especially impactful.

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. Arcutis Presents New Phase 2 Results in Infants with Atopic Dermatitis in Late-Breaking Session Today at the 2026 American Academy of Dermatology Annual Meeting. Arcutis. March 28, 2026. https://www.globenewswire.com/de/news-release/2026/03/28/3264182/0/en/Arcutis-Presents-New-Phase-2-Results-in-Infants-with-Atopic-Dermatitis-in-Late-Breaking-Session-Today-at-the-2026-American-Academy-of-Dermatology-Annual-Meeting.html.

2. Eichenfield L. New Data Support Roflumilast Cream in Infants with Eczema Over 4 Weeks, With Lawrence Eichenfield, MD. HCPLive. March 29, 2026. Accessed March 28, 2026. https://www.hcplive.com/view/new-data-support-roflumilast-cream-infants-eczema-over-4-weeks-lawrence-eichenfield-md.