Analysis of adverse reaction characteristics of four biologics for the treatment of chronic sinusitis with nasal polyps: A descriptive analysis from WHO-VigiAccess

Background

Chronic rhinosinusitis with nasal polyps (CRSwNP) imposes a significant global disease burden. However, systematic comparisons of adverse drug reaction (ADR) profiles among these agents remain scarce, necessitating large-scale pharmacovigilance evaluation.

Methods

Utilizing the WHO VigiAccess database, we analyzed 402,778 ADR reports for four biologics—omalizumab, dupilumab, mepolizumab, and tezepelumab. Descriptive statistics and disproportionality analyses (reporting odds ratio [ROR], proportional reporting ratio [PRR]) were performed to identify safety signals across 27 system organ classes (SOCs). Severity stratification included fatal, hospitalization-requiring, and major adverse events.

Results

Females accounted for 56.08 %–65.80 % of reports, with geographic disparities (Americas: 70.91 %–91.98 %). Temporal trends revealed surging reports for newer agents (dupilumab: 26.62 % in 2024) versus declining rates for older therapies (omalizumab: 44.71 % pre-2019). Distinct SOC patterns emerged: dupilumab dominated cutaneous (24.40 %) and ocular ADRs (ROR = 6.51), while omalizumab showed elevated pregnancy-related risks (ROR = 12.15). Mepolizumab exhibited a 4.6-fold higher severe event incidence (1.81 %) versus dupilumab (0.39 %). Tezepelumab demonstrated unique musculoskeletal ADRs (10.02 %) and cardiac risks (ROR = 3.21).

Conclusions

This study delineates agent-specific ADR profiles tied to mechanistic targets, advocating for tailored monitoring strategies. Findings underscore the imperative for risk-stratified biologic selection in CRSwNP management, supported by ongoing pharmacovigilance and mechanistic investigations.