Abstract
OBJECTIVE: Phase III trials have shown that dupilumab is an effective and well-tolerated adjunct treatment for patients with uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP). However, real-world data pertaining to tolerability and adverse effects (AE) are lacking. The goal of this study is to investigate AE incidence, timing, and medication discontinuation. METHODS: This is a retrospective cohort study at a single tertiary care institution. Patients initiating treatment with dupilumab for CRSwNP over a four-year period (2020-2023) with at least six months of follow-up were included. Univariate analysis and multivariable logistic regression were performed to investigate relevant clinical factors associated with AEs. Univariate analysis was also performed to determine factors associated with discontinuation due to AEs. RESULTS: 115 patients received at least one dose of dupilumab. Mean age (SD) was 51.0 (14.9) years, and 44% were female. 39 patients reported at least one AE, with 15 having more than one AE. 15 patients (13.0%) discontinued the medication due to an AE. Ocular AEs were the most common (15), followed by injection site reactions (10), musculoskeletal (9), and non-injection site skin reactions (8). Female sex was significantly associated with AEs and discontinuation due to AEs. CONCLUSION: While dupilumab is an effective treatment option for uncontrolled CRSwNP, the incidence of AEs and discontinuation rates were higher than reported in Phase III trials. Additional real-world data pertaining to AEs can aid in clinical decision-making and patient counseling.