@article{9fb27266fd2246f7a08c50c0398adc21,
title = "Efficacy and safety of benralizumab in chronic rhinosinusitis with nasal polyps: A randomized, placebo-controlled trial",
abstract = "Background: Eosinophilic inflammation has been implicated in the pathogenesis, severity, and treatment responsiveness of chronic rhinosinusitis with nasal polyps (CRSwNP). Objective: We sought to assess the efficacy and safety of benralizumab-mediated eosinophil depletion for treating CRSwNP. Methods: The phase 3 OSTRO study enrolled patients with severe CRSwNP who were symptomatic despite treatment with intranasal corticosteroids and who had a history of systemic corticosteroid (SCS) use and/or surgery for nasal polyps (NP). Patients were randomized 1:1 to treatment with benralizumab 30 mg or placebo every 4 weeks for the first 3 doses and every 8 weeks thereafter. Coprimary end points were change from baseline to week 40 in NP score (NPS) and patient-reported mean nasal blockage score reported once every 2 weeks. Results: The study population comprised 413 randomized patients (207 in the benralizumab group and 206 in the placebo group). Benralizumab significantly improved NPS and nasal blockage score compared to placebo at week 40 (P ≤ .005). Improvements in Sinonasal Outcome Test 22 score at week 40, time to first NP surgery and/or SCS use for NP, and time to first NP surgery were not statistically significant between treatment groups. Nominal significance was obtained for improvement in difficulty in sense of smell score at week 40 (P = .003). Subgroup analyses suggested influences of comorbid asthma, number of NP surgeries, sex, body mass index, and baseline blood eosinophil count on treatment effects. Benralizumab was safe and well tolerated. Conclusion: Benralizumab, when added to standard-of-care therapy, reduced NPS, decreased nasal blockage, and reduced difficulty with sense of smell compared to placebo in patients with CRSwNP. Trial registration: ClinicalTrials.gov",
keywords = "Eosinophils, IL-5 receptor, biologic, eosinophilia, intranasal corticosteroids, nasal blockage, nasal polyposis, sinonasal polyposis, systemic corticosteroids, type 2 inflammation",
author = "Claus Bachert and Han, {Joseph K.} and Desrosiers, {Martin Y.} and Philippe Gevaert and Enrico Heffler and Claire Hopkins and Tversky, {Jody R.} and Peter Barker and David Cohen and Claire Emson and Martin, {Ubaldo J.} and Shih, {Vivian H.} and Sofia Necander and Kreindler, {James L.} and Maria Jison and Viktoria Werkstr{\"o}m",
note = "Funding Information: This work was supported by AstraZeneca . AstraZeneca was involved in the study design; collection, analysis, and interpretation of data; and in the development and review of the report. The decision to submit the report for publication was made by the authors. Funding Information: This work was supported by AstraZeneca. AstraZeneca was involved in the study design; collection, analysis, and interpretation of data; and in the development and review of the report. The decision to submit the report for publication was made by the authors. Disclosure of potential conflict of interest: C. Bachert received research funding and/or consulting fees from Sanofi, AstraZeneca, GSK, Novartis, Viatris, and ALK. J. K. Han received consulting fees from AstraZeneca, Sanofi Genzyme, Genentech, Roche, GSK, Medtronic, and Gossamer Bio. M. Desrosiers received consulting fees, honoraria for lectures, and/or research funding from AstraZeneca, GSK, MEDA Pharmaceuticals, and Sanofi; owns stock in Probionase Therapies Inc; and is CPD designate, ORL-CCF Program, Universit? de Montr?al. P. Gevaert received consulting fees, honoraria for lectures, and/or research funding from 3NT, ALK, Argenx, AstraZeneca, Genentech, Hall Allergy, Novartis, Regeneron, Roche, Sanofi Genzyme, Stallergenes Greer, and Teva. E. Heffler received consulting fees, honoraria for lectures, and/or research funding from AstraZeneca, Sanofi, Novartis, GSK, Stallergenes Greer, Circassia, and Nestl? Purina. C. Hopkins received consulting fees, honoraria for lectures from AstraZeneca, GSK, Intersect, Meda, Olympus, Regeneron, Sanofi Genzyme, and Smith and Nephew. J. Tversky received research funding and/or consulting fees from Regeneron, AstraZeneca, and Flare Diagnostics. P. Barker, D. Cohen, C. Emson, U. J. Martin, V. H. Shih, S. Necander, J. L. Kreindler, M. Jison, and V. Werkstr?m are employees of AstraZeneca and may have stock options. Publisher Copyright: {\textcopyright} 2021 American Academy of Allergy, Asthma & Immunology",
year = "2022",
month = apr,
doi = "10.1016/j.jaci.2021.08.030",
language = "English (US)",
volume = "149",
pages = "1309--1317.e12",
journal = "Journal of Allergy and Clinical Immunology",
issn = "0091-6749",
publisher = "Mosby Inc.",
number = "4",
}