Roflumilast Cream 0.05% Provides Sustained Improvements in Quality of Life and Family Impact in Pediatric Atopic Dermatitis
Long-term results from the INTEGUMENT-OLE trial demonstrate that roflumilast cream 0.05% provides sustained improvements in disease severity, quality of life, and family burden in young children with atopic dermatitis (AD).
“Signs and symptoms of AD can negatively impact quality of life for both patients and their families,” the investigators noted, emphasizing the need for safe, long-term topical therapies in pediatric populations.
This analysis included 562 patients aged 2 to 5 years who continued into the open-label extension after completing the INTEGUMENT-PED trial. Patients received once-daily roflumilast cream, with the option to transition to proactive twice-weekly dosing after achieving disease control (Validated Investigator Global Assessment-AD 0). Outcomes included caregiver-reported and patient-reported measures, such as SCORing Atopic Dermatitis (SCORAD), Patient Oriented Eczema Measure (POEM), Children’s Dermatology Life Quality Index (CDLQI), Infant’s Dermatology Life Quality Index (IDQoL), and Dermatitis Family Impact (DFI).
Clinical improvements were rapid and sustained. Reductions in disease severity (SCORAD and POEM) and itch were observed early and maintained through 56 weeks. The proportion of patients achieving minimal itch (Worst Itch-Numerical Rating Scale 0/1) increased over time, reaching approximately 40% by week 56.
Quality-of-life outcomes also improved significantly. Mean scores for CDLQI, IDQoL, and DFI decreased steadily over time, reflecting reduced impact on both patients and caregivers across domains such as sleep, daily activities, emotional well-being, and family functioning.
Safety findings were favorable. Roflumilast cream was well tolerated, with no treatment-related serious adverse events and low discontinuation rates (~3%).
“Roflumilast cream 0.05% demonstrated durable improvements in [patient-reported outcomes] in patients aged 2 to 5 years with mild-to-moderate AD,” the authors concluded. “Improvements observed at 4 weeks in the parent trial (INTEGUMENT-PED) were maintained/continued to improve through up to 56 weeks of application.”
These findings support roflumilast cream as a well-tolerated, long-term topical option that addresses both clinical symptoms and the broader psychosocial burden of pediatric AD.
Reference
Eichenfield LF, Boguniewicz M, Lee LW, et al. Once-daily and proactive twice-weekly roflumilast cream 0.05% provides improvements in caregiver-reported outcomes that are maintained long term: results for patients aged 2–5 years with mild-to-moderate atopic dermatitis in the INTEGUMENT-OLE trial. Presented at: American Academy of Dermatology Annual Meeting; March 27–31, 2026; Denver, Colorado.
