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      Real‐World Adverse Events After Type 2 Biologic use in Chronic Rhinosinusitis with Nasal Polyps

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          Abstract

          Objective

          To investigate the frequency and nature of adverse events related to type 2 biologic use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), including dupilumab and mepolizumab.

          Methods

          This is a single‐institution retrospective study of real‐world patient data. Patients were included if they have a diagnosis of CRSwNP, have undergone at least one endoscopic sinus surgery, and have taken at least two doses of dupilumab or mepolizumab between January 1, 2016, and July 1, 2023. Data collected include clinicodemographic information and past medical/surgical history. The primary outcomes are the incidence and types of adverse events. Adjusted odds ratio was calculated to compare the biologics using logistic regression. Risk factors for developing adverse events were investigated.

          Results

          Eighty‐seven patients on dupilumab and 51 patients on mepolizumab were included. Thirty‐nine (45%) and 10 (20%) patients respectively encountered adverse events, which differed from phase 3 trial data. The adjusted odds ratio for adverse event rates between these two treatment groups was 3.8 (95% CI, 1.5–10.5). The most common adverse events for dupilumab were arthralgia (16%), rash (14%), and conjunctivitis or xerophthalmia (10%). The main adverse events for mepolizumab were headache (6%) and fatigue (6%). Seven dupilumab and three mepolizumab patients discontinued therapy due to adverse events. The average duration of treatment was 22.5 (range: 1–77) months for mepolizumab and 15.9 (range: 1–35) months for dupilumab.

          Conclusion

          Dupilumab and mepolizumab have distinct adverse event profiles. This study contributes to informing clinicians' decisions regarding the use of type 2 biologics in CRSwNP patients.

          Level of Evidence

          3 Laryngoscope, 134:3054–3059, 2024

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          Author and article information

          Contributors
          (View ORCID Profile)
          (View ORCID Profile)
          (View ORCID Profile)
          Journal
          The Laryngoscope
          The Laryngoscope
          Wiley
          0023-852X
          1531-4995
          July 2024
          February 05 2024
          July 2024
          : 134
          : 7
          : 3054-3059
          Affiliations
          [1 ] Faculty of Medicine University of British Columbia Vancouver British Columbia Canada
          [2 ] Department of Otolaryngology—Head and Neck Surgery University of British Columbia Vancouver British Columbia Canada
          Article
          10.1002/lary.31305
          38314858
          fc76a014-4121-4e1a-823c-db46ca77ad52
          © 2024

          http://creativecommons.org/licenses/by-nc/4.0/

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