Facial Rash Events in Dupilumab Phase 3 Atopic Dermatitis Trials: A Pooled Analysis.

Background

Since dupilumab approval for moderate-to-severe atopic dermatitis (AD) in 2017, facial rash reports appeared in literature.

Objective

To report facial rash treatment-emergent adverse events (TEAEs) incidence in dupilumab clinical trials for moderate-to-severe AD.

Methods

Data were pooled from 14 randomized, placebo-controlled dupilumab clinical trials in pediatric (6-17 years) and adult (≥18 years) patients and were searched for facial rash TEAEs occurring during study treatment period, focusing on Medical Dictionary for Regulatory Activities (MedDRA) Lowest Level Terms (LLTs).

Results

Pooled dataset included 1349 placebo-treated and 2615 dupilumab-treated patients. Facial rash incidence was low but slightly higher in dupilumab (dupilumab: 25 [1.0%]; placebo: 9 [0.7%] patients). The following LLT rates were numerically higher in dupilumab than placebo-treated patients: Erythema facial (7 [0.3%, 0.8 number of events (nE)/100 patient-years (PY)] vs 1 [<0.1%, 0.1 nE/100PY]); Redness facial (2 [<0.1%, 0.2 nE/100PY] vs 0); and rash on face (5 [0.2%, 0.4 nE/100PY] vs 1 [<0.1%, 0.1 nE/100PY]). Most cases were mild-to-moderate and recovered/resolved during study period; none led to treatment discontinuation.

Conclusions

Facial rash analysis focused on MedDRA LLTs in dupilumab clinical trials for moderate-to-severe AD showed a small increase in dupilumab-treated patients compared with placebo. Most were mild-to-moderate and not treatment-limiting.