Pharmacovigilance signals of dupilumab among pediatric patients: A real‑world analysis based on the FAERS database

Abstract

Dupilumab is effective for the treatment of moderate‑to‑severe type 2 inflammatory diseases; however, its real‑world safety profile in pediatric patients remains to be further clarified. This retrospective pharmacovigilance study analyzed U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) data from 2017 to 2025, including 44,593 reports where dupilumab was the primary suspect drug in children. Disproportionality analyses (ROR, PRR, BCPNN, MGPS), time-to-onset analysis, stratified analysis, and Weibull modeling assessed adverse event (AE) distribution and patterns. Results showed balanced sex distribution (male 50.1%, female 48.6%), with adolescents (12-17y) most common (45.3%), and report counts increasing over time. 93 positive safety signals were detected. The most common core AEs were rash (4,105 cases; ROR = 4.55, 95% CI: 4.38-4.72), injection site pain (3,582 cases; ROR = 8.59, 95% CI: 8.22-8.97), and skin exfoliation (1,834 cases; ROR = 3.41, 95% CI: 3.23-3.59). Potential unlisted signals included vitiligo (33 cases; ROR = 10.46, 95% CI: 6.52-16.78), skin depigmentation (32 cases; ROR = 13.04, 95% CI: 7.85-21.66), and eye color change (13 cases; ROR = 7.06, 95% CI: 3.54-14.11). Stratified analyses indicated distinct patterns of adverse‑event reporting across age and sex strata. Among cases with complete temporal information, most AEs occurred within 30d after dupilumab initiation, with a median time‑to‑onset of 14d. In conclusion, this large-scale spontaneous-reporting study detected potential safety signals in children. Given FAERS data limitations, the associations should be viewed as hypothesis-generating rather than confirmatory, and may inform future signal validation and prospective studies.

The authors' abstract, as published at the source. Human Vaccines & Immunotherapeutics, 2026 · DOI ↗