FDA-Approved Biologics for CRSwNP: A Five-Year Analysis of the FDA Adverse Event Reporting System

Objectives

Given the increasing utilization of biologics in the treatment of CRSwNP, it is important to characterize their adverse events (AEs). This study compares the AE profiles of FDA-approved biologics for CRSwNP when adjusting for potential confounders, such as prescription indication, age, and sex.

Methods

We retrospectively reviewed AEs reported in the FDA Adverse Events Reporting System (FAERS) from 2019Q1 to 2023Q2. AEs were categorized and compared between biologics for comparison of AE type and severity. Chi-square tests compared outcomes between groups and regression modeling identified predictors of a serious adverse event (SAE).

Results

We identified ~79,000 AE logs consisting of ~226,000 individual adverse reactions (IARs). Most dupilumab IARs were dermatologic or administration/medical error related. Most mepolizumab were administration/medical error related or pulmonary. Most omalizumab were pulmonary or dermatologic. Compared to dupilumab, we found that mepolizumab (OR 3.61, 95% CI: 3.29–3.98) and omalizumab (OR 15.33, 95% CI: 13.98–16.81) had a greater odds of a reported AE being an SAE. Though more females reported having any AE, male sex, increasing age, and a prescription indication of asthma were associated with a significantly increased odds of an AE being an SAE.

Conclusion

We found potential predictors associated with SAEs to FDA approved biologics including gender (male > female), age (increasing age), and prescription indication (asthma > asthma + CRSwNP > CRSwNP). This data is important to prescribers educating their patients to potential AEs.