INTEGUMENT-OLE Data Show Sustained Efficacy of Roflumilast in Early Childhood AD
Key Takeaways
Results from INTEGUMENT-OLE suggested roflumilast cream 0.05% was efficacious and had favorable long-term safety in children aged 2 to 5 years with mild-to-moderate atopic dermatitis (AD).
At week 56, 63.1% of patients achieved clear or almost clear skin (vIGA-AD 0/1), with continued improvement in itch and disease severity measures.
Patients who achieved clear skin and moved to twice-weekly treatment maintained disease control for a median of 238 days.
The 56-week phase 3 open-label extension for the INTEGUMENT trial (INTEGUMETN-OLE) indicated once-daily roflumilast cream 0.05% maintained efficacy and demonstrated favorable long-term safety in children aged 2 to 5 years with mild-to-moderate atopic dermatitis (AD).
Study authors, publishing in the Journal of Pediatric Dermatology, focused on long-term safety and efficacy of topical roflumilast cream 0.05% in children who previously completed the 4-week phase 3 INTEGUMENT-PED trial. Caregivers applied roflumilast to AD-affected areas for up to 56 weeks. Patients who achieved a Validated Investigator Global Assessment for AD (vIGA-AD) score of 0 (clear skin) at or after week 4 transitioned to proactive twice-weekly application. The primary endpoint was long-term safety, assessed through adverse events (AEs) and application-site tolerability.
Among 562 enrolled patients, treatment-related AEs occurred in 14 (2.5%). Serious AEs were reported in 18 patients (3.2%), none of which were considered treatment related. Most treatment-emergent AEs were mild or moderate. Investigators reported no application-site irritation in at least 97% of patients across study visits. By week 56, 63.1% of patients achieved vIGA-AD 0/1. Rates of vIGA-AD success were 53.8% among those continuing roflumilast and 55.0% among those who switched from vehicle to roflumilast. Improvements were also observed across other endpoints, including Eczema Area and Severity Index improvement of at least 75% (EASI-75) and improvements in itch severity measured by the Worst Itch Numeric Rating Scale.
A total of 170 patients (30.2%) achieved clear skin and transitioned to proactive twice-weekly dosing. Further analysis showed a median duration of disease control of 238 days while maintaining vIGA-AD 0/1.
“Roflumilast cream 0.05% for up to 56 weeks was well tolerated and provided durable efficacy in 2–5-year-old patients with mild-to-moderate AD,” the authors wrote. “Among patients who achieved clear skin, clear/almost clear skin and adequate disease control (including pruritus) were maintained for approximately 8 months with proactive BIW application.”
Eichenfield L, et al. Journal of Pediatric Dermatology. 2026. Doi:10.1111/pde.70177