Dupilumab Adverse Events in Nasal Polyp Treatment: Analysis of FDA Adverse Event Reporting System.

Abstract

Dupilumab was the first biologic approved to treat chronic rhinosinusitis with nasal polyps (CRSwNP). While the risk of adverse events in phase-III clinical trials was low, dupilumab-associated adverse reactions (DAR) with real-world use is unknown and potentially under-reported. We aimed to evaluate DAR for CRSwNP treatment (CRSwNP-tx) using the FDA Adverse Event Reporting System (FAERS). Retrospective database study. FAERS was queried for DAR from 2019Q1 to 2021Q2. Individual DAR (iDAR) were categorized and quantitatively compared between treatment groups (CRSwNP, asthma, atopic dermatitis). Zero-truncated Poisson regression was modeled to predict the number of iDAR, and logistic regression was modeled to predict serious DARs. There were 15,411 DAR observations; 911 for CRSwNP-tx, of which 121 (13.3%) had serious reactions and 3 died. Common CRSwNP-tx iDAR were dermatologic (13.9%), generalized (13.3%), and injection-site (10.8%) symptoms. The number of CRSwNP-tx iDAR was 2.99 [2.81, 3.17], compared to 3.44 [3.32, 3.56] for asthma and 3.18 [3.13, 3.24] for atopic dermatitis (Kruskal-Wallis test, P< .001). For CRSwNP-tx, iDAR reported-risk-ratio was 0.84 [0.77, 0.92] among men and 1.12 [1.04, 1.22] among older adults (>50). Serious DAR reported-odds-ratio was 1.37 [0.91, 2.04] among men and 1.39 [0.93, 2.08] among older adults. While there are limitations with FAERS, this analysis suggests CRSwNP-tx is associated with fewer iDAR compared with other treatment indications. More iDAR are experienced among women and older adults, but men tend to have more serious DAR. 3 Laryngoscope, 132:2307-2313, 2022.