Divergent Eosinophilic and Paradoxical Inflammatory Adverse-Event Signatures Across Five Type 2 Asthma Biologics: A FAERS Active-Comparator Disproportionality Analysis

A study analyzed adverse events of five biologic drugs used to treat severe type 2 asthma (tezepelumab, dupilumab, mepolizumab, benralizumab, and omalizumab) using the FAERS database during 2022-2024. Among 50,360 reports, distinct safety profiles were identified for individual drugs. Benralizumab showed increased reports of EGPA (eosinophilic granulomatosis with polyangiitis), vasculitis, and peripheral eosinophilia. Mepolizumab was associated with vasculitis. Dupilumab showed increased reports of ocular inflammation, which occurred earlier (20-44 days) than in IL-5 axis-targeted drugs (195-550 days). Tezepelumab and omalizumab showed no robust signals in any category. The results suggest that adverse events are drug-specific rather than common to the entire drug class.