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Facial Rash Events in Dupilumab Phase 3 Atopic Dermatitis Trials: A Pooled Analysis
Amy S Paller1,2, Marjolein de Bruin-Weller3, Eric L Simpson4
1From the, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Dermatitis : Contact, Atopic, Occupational, Drug
|October 30, 2025
Summary
Dupilumab for moderate-to-severe atopic dermatitis (AD) showed a slight increase in facial rash treatment-emergent adverse events (TEAEs) compared to placebo. Most facial rash cases were mild-to-moderate and resolved without treatment discontinuation.
Area of Science:
- Dermatology
- Clinical Pharmacology
Background:
- Dupilumab, approved in 2017 for moderate-to-severe atopic dermatitis (AD), has been associated with reports of facial rash in post-marketing literature.
- Understanding the incidence and characteristics of facial rash is crucial for patient management.
Purpose of the Study:
- To quantify the incidence of facial rash treatment-emergent adverse events (TEAEs) in patients with moderate-to-severe AD participating in dupilumab clinical trials.
- To analyze specific facial rash events using MedDRA Lowest Level Terms (LLTs).
Main Methods:
- Pooled data from 14 randomized, placebo-controlled clinical trials involving pediatric and adult patients with moderate-to-severe AD.
- Systematic search for facial rash TEAEs during the study treatment period, categorized by MedDRA LLTs.
Main Results:
- The study included 1349 placebo-treated and 2615 dupilumab-treated patients.
- Facial rash incidence was low but numerically higher in the dupilumab group (1.0%) compared to placebo (0.7%).
- Specific LLTs like erythema facial, redness facial, and rash on face showed slightly higher rates with dupilumab. Most events were mild-to-moderate and resolved.
Conclusions:
- Analysis of MedDRA LLTs in dupilumab trials for moderate-to-severe AD indicates a small increase in facial rash incidence compared to placebo.
- The observed facial rashes were predominantly mild-to-moderate and did not necessitate treatment discontinuation, suggesting a manageable safety profile regarding this adverse event.
