Once-daily Roflumilast Cream 0.05% for the Treatment of Atopic Dermatitis in Patients Aged 2–5 Years With Diverse Skin Types: Subgroup Analysis From the Phase 3 INTEGUMENT-PED Trial
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Keywords
roflumilast cream 0.05%, atopic dermatitis, children, skin of color
Abstract
Once-daily roflumilast cream 0.05%, a topical phosphodiesterase 4 inhibitor, was approved for the treatment of mild-to-moderate atopic dermatitis (AD) in patients aged 2–5 years based on the safety and efficacy results of the phase 3 INTEGUMENT-PED trial (NCT04845620). This analysis reports treatment response in patients from INTEGUMENT-PED across a diverse range of skin types in subgroups by race, ethnicity, and Fitzpatrick skin type (FST).
Caregivers of patients aged 2–5 years with Validated Investigator Global Assessment for AD (vIGA-AD) of mild (2) or moderate (3) applied roflumilast cream 0.05% or vehicle cream once daily for 4 weeks. Week-4 efficacy outcomes included vIGA-AD success (clear [0] or almost clear [1] plus ≥2-grade improvement), Worst Itch-Numeric Rating Scale (WI-NRS) success (≥4-point improvement in patients with baseline WI‑NRS score ≥4), and ≥75% improvement in Eczema Area and Severity Index (EASI-75).
Of 651 participants, analyses were performed by race (White [69.1%], non-White [30.9%]), ethnicity (not Hispanic or Latino [82.2%], Hispanic or Latino [17.4%]), and FST (I–III [65.6%], IV–VI [34.3%]). vIGA-AD success was achieved at week 4 by a higher proportion of patients who received roflumilast versus vehicle across the subgroups for race (White: 28.5% vs 10.8% [P<0.0001]; non-White: 18.9% vs 10.4%), ethnicity (not Hispanic or Latino: 23.6% vs 10.2% [P<0.001]; Hispanic or Latino: 33.8% vs 13.5% [P<0.05]), and FST (I–III: 26.3% vs 10.1% [P<0.0001]; IV–VI: 23.7% vs 12.1% [P<0.05]). WI-NRS success at week 4 followed a similar trend for race (White: 35.9% vs 15.7% [P<0.001]; non-White: 34.2% vs 24.3%), ethnicity (not Hispanic or Latino: 33.6% vs 16.7% [P<0.001]; Hispanic or Latino: 42.5% vs 25.1% [P=0.13]), and FST (I–III: 34.5% vs 17.7% [P<0.01]; IV–VI: 36.8% vs 19.2% [P<0.05]). Roflumilast cream 0.05% applied for 4 weeks improved signs and symptoms of AD in children aged 2–5 years across a diverse range of skin types. Sponsored by Arcutis Biotherapeutics, Inc.
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