Improvement in Atopic Dermatitis Signs and Symptoms With Once-Daily and Proactive Twice-Weekly Roflumilast Cream 0.15% or 0.05%: Results From the 52-Week Phase 3 INTEGUMENT-OLE Trial in Patients Aged ≥2 Years

Document Type

Conference Proceeding

Publication Date

2-10-2026

Publication Title

J Allergy Clin Immunol

Keywords

corticosteroid, roflumilast, adverse drug reaction, atopic dermatitis, body surface, conference abstract, controlled study, drug therapy, Eczema Area and Severity Index, female, human, integument, major clinical study, male, pharmacology, phase 3 clinical trial, randomized controlled trial, side effect

Abstract

Rationale: Roflumilast cream demonstrated efficacy and safety for atopic dermatitis (AD) in ≥2-year-olds in randomized, vehicle-controlled, 4-week, phase 3 trials (INTEGUMENT-1/2; INTEGUMENT-PED). A phase 3, open-label extension (OLE) trial (INTEGUMENT-OLE [NCT04804605]) investigated long-term outcomes. Methods: Patients who completed INTEGUMENT-1/2 or INTEGUMENT-PED (parent studies) could enroll in INTEGUMENT-OLE; roflumilast cream 0.15%/0.05% (≥6/2–‍5 years) was applied once daily for ≤52 weeks. Patients achieving Validated Investigator Global Assessment for AD (vIGA-AD) 0 (clear) at/after OLE week 4 transitioned to proactive twice-weekly (BIW) application, which was continued as long as ‘disease control’ (vIGA-AD 0/1 [clear/almost clear] and adequate AD sign/symptom control) was maintained. vIGA-AD, Eczema Area and Severity Index (EASI), mean body surface area affected (BSA), and safety were assessed. Results: At OLE week 52, vIGA-AD 0/1 rates were 55.7% (117/210) and 63.1% (234/371) for INTEGUMENT-1/2 and INTEGUMENT-PED groups, respectively; mean EASI (10.45 to 2.79; 12.18 to 2.59) and mean BSA (14.8% to 3.7%; 22.3% to 4.9%) decreased from parent-study baseline. At/after OLE week 4, 19.8% (130/658) and 30.2% (170/562) of patients in respective groups transitioned to BIW application with median durations of ‘disease control’ of 281 and 238 days (Kaplan-Meier estimates). Treatment-related adverse events were reported for 4.7% and 2.5% of patients from INTEGUMENT-1/2 and INTEGUMENT-PED, respectively, and application-site pain adverse events for <1% of patients overall. Conclusions: Roflumilast cream was well tolerated and provided long-term decreases in AD signs/symptoms for patients aged ≥2 years, supporting the use of roflumilast cream for long-term AD control, including proactive BIW application, without topical corticosteroids.

Volume

157

Issue

2

First Page

AB5

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