Long‐Term Safety and Efficacy of Once‐Daily and Proactive Twice‐Weekly Roflumilast Cream 0.05% for Mild‐to‐Moderate Atopic Dermatitis in Children Aged 2–5 Years From a 52‐Week, Phase 3 Trial ( INTEGUMENT ‐ OLE )
Year: 2026
Type: article
Abstract: BACKGROUND: INTEGUMENT-PED/NCT04845620, a 4-week, phase 3 trial, demonstrated efficacy and safety of roflumilast cream 0.05% in children aged 2-5 years with mild-to-moderate atopic dermatitis (AD). A phase 3 open-label extension trial (INTEGUMENT-OLE [NCT04804605]) investigated long-term outcomes continuing roflumilast cream for ≤ 56 weeks. METHODS: Caregivers of eligible patients from INTEGUMENT-PED applied roflumilast cream 0.05% once-daily in INTEGUMENT-OLE. Patients achieving Validated Investigator Global Assessment for AD (vIGA-AD) clear (0) at/after week 4 of INTEGUMENT-OLE switched to twice-weekly (BIW) application. Evaluation of safety (adverse events [AEs] and application-site tolerability) was the primary objective. Efficacy endpoints assessed from INTEGUMENT-PED baseline included vIGA-AD success (clear/almost clear [0/1] plus ≥ 2-point improvement), vIGA-AD 0/1, ≥ 75% improvement in Eczema Area and Severity Index, and Worst Itch-Numeric Rating Scale success (≥ 4-point improvement in patients with baseline score ≥ 4). Duration of vIGA-AD 0/1 and sign/symptom control ("disease control") with BIW application was determined. RESULTS: Among 562 patients, 14 (2.5%) had treatment-related AEs reported. Roflumilast was well tolerated; application-site pain AEs were reported for four (0.7%) patients. At treatment-week 56, AD signs/symptoms continued to improve (63.1% of patients achieved vIGA-AD 0/1). Of 170 (30.2%) patients who switched to BIW application, the median Kaplan-Meier duration of "disease control" was 238 days. CONCLUSIONS: Roflumilast cream 0.05% demonstrated a favorable long-term safety profile and durable efficacy for up to 56 weeks of treatment in children aged 2-5 years with AD, and "disease control" was maintained with BIW application. These results are consistent with previous studies, including patients aged ≥ 6 years from INTEGUMENT-OLE. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT04845620.
Source: Pediatric Dermatology
Institutions: University of California San Diego, Rady Children's Hospital-San Diego, National Jewish Health, University of Colorado Anschutz, University of Colorado Denver, Oregon Health & Science University, The University of Texas Health Science Center at Houston, University of Calgary, Probity Medical Research
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,920
OpenAlex ID: W7134179850