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 )

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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

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