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Atopic dermatitis (AD) is a long-term inflammatory skin disorder that often begins in early childhood and requires safe, effective long-term treatment strategies.
Once-daily roflumilast cream 0.05% provides sustained long-term disease control with a favorable safety profile, while proactive twice-weekly maintenance helps preserve clinical improvement in young children with mild-to-moderate atopic dermatitis.
Atopic dermatitis (AD) is a long-term inflammatory skin disorder that often begins in early childhood and requires safe, effective long-term treatment strategies. The phase 3 INTEGUMENT-PED trial previously depicted the short-term potency of roflumilast cream 0.05% in kids aged 2–5 years with mild-to-moderate AD. The open-label extension study, INTEGUMENT-OLE, determined the long-term safety, sustained efficacy, and potency of proactive twice-weekly maintenance therapy with roflumilast cream for up to 56 weeks.
This phase 3, open-label extension trial enrolled eligible participants from the INTEGUMENT-PED study. Caregivers applied roflumilast cream 0.05% once daily. Participants who attained a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear skin) at or after week 4 shifted to a proactive maintenance regimen with twice-weekly treatment.
The primary endpoint assessed long-term safety through treatment-linked adverse events and application-site tolerability. Efficacy outcomes included vIGA-AD success, achievement of clear or almost clear skin (vIGA-AD 0/1), a minimum of 75% improvement in the Eczema Area and Severity Index (EASI-75), improvement in itch measured by the Worst Itch–Numeric Rating Scale (WI-NRS), and the duration of disease control during twice-weekly maintenance therapy.
The study included 562 children suffering from mild-to-moderate AD. Long-term treatment depicted an excellent safety profile, with treatment-related adverse events reported in only 14 patients (2.5%). Application-site pain occurred in just four children (0.7%), confirming favorable local tolerability. Clinical improvements were maintained and continued to increase throughout the study.
By week 56, 63.1% of patients attained vIGA-AD 0/1, indicating clear or almost clear skin with sustained improvement in disease severity. Among the 170 kids (30.2%) who transitioned to proactive twice-weekly therapy after attaining complete clearance, the median Kaplan–Meier duration of disease control reached 238 days, illustrating that reduced-frequency maintenance successfully prolonged remission while minimizing treatment burden.
Roflumilast cream 0.05% demonstrated sustained long-term safety and durable clinical efficacy for up to 56 weeks in children aged 2–5 years with mild-to-moderate AD. Proactive twice-weekly maintenance therapy maintained disease control for a prolonged period after skin clearance, supported sustained symptom remission, and reinforced its potential as a valuable long-term management strategy for pediatric AD.
Pediatric Dermatology
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)
Lawrence F Eichenfield et al.
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