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

<u><b><i></i></b></u> <u><b><i>Background:</i></b></u> Since dupilumab approval for moderate-to-severe atopic dermatitis (AD) in 2017, facial rash reports appeared in literature.<u><b><i>Objective:</i></b></u> To report facial rash treatment-emergent adverse events (TEAEs) incidence in dupilumab clinical trials for moderate-to-severe AD.<u><b><i>Methods:</i></b></u> 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).<u><b><i>Results:</i></b></u> 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.<u><b><i>Conclusions:</i></b></u> 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.