Disproportionality Analysis of FDA Adverse Event Reporting System (FAERS) Events for Dupilumab and Mepolizumab in Patients with Chronic Rhinosinusitis with Nasal Polyps
Supervising author: Christopher Campbell
Underlined: presenting author
Background
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous inflammatory disease characterized by chronic sinonasal inflammation. Pathogenesis includes upregulation of type 2 (T2) cytokines, including IL-4, IL-13, and IL-5. Dupilumab (anti-IL-4Rα) and mepolizumab (anti-IL5) are FDA-approved CRSwNP biologics targeting different components of the T2 inflammatory cascade. Comparative pharmacovigilance for these two drugs is important for informing clinical decision-making.
Objective
To characterize each signal distribution by severity, demographics, time to onset, and concomitant medication use for dupilumab and mepolizumab in CRSwNP.
Methods
A retrospective pharmacovigilance study using FAERS data (Q1 2015-Q4 2025). Disproportionality was assessed using a six-metric framework (ROR, PRR, IC/BCPNN, EBGM/MGPS, Chi-Squared, Logistic Regression). Subgroup analyses included report type, demographic, concomitant medication, outcome, and temporal stratification. Weibull modeling assessed time-to-onset.
Results
We identified 27,052 dupilumab and 1,113 mepolizumab cases. Dupilumab was associated predominantly with ocular and injection-site AEs, plus musculoskeletal (arthralgia) and olfactory (anosmia) signals. Mepolizumab showed stronger relative signals for hematologic, cardiac, and respiratory AEs. Dupilumab showed female-predominant ocular but male-predominant injection-site signals; mepolizumab showed female-predominant respiratory signals. Concurrent oral corticosteroids use amplified AE reporting more for mepolizumab than dupilumab. Weibull modeling showed early failure patterns for most AEs.
Conclusion
Dupilumab's side effects are broader but milder (mainly ocular/injection-site), whereas mepolizumab's are fewer but more severe (primarily respiratory, risking females and OCS users). These distinct safety profiles allow for personalized biologic choice and monitoring in CRSwNP.