@article{95a262ba0f364d6b8b2c84622f92d202,
title = "Mepolizumab for chronic rhinosinusitis with nasal polyps: Treatment efficacy by comorbidity and blood eosinophil count",
abstract = "Background: In the phase III SYNAPSE study, mepolizumab reduced nasal polyp (NP) size and nasal obstruction in chronic rhinosinusitis with NP. Objective: We sought to assess the efficacy of mepolizumab in patients from SYNAPSE grouped by comorbid asthma, aspirin-exacerbated respiratory disease (AERD), and baseline blood eosinophil count (BEC). Methods: SYNAPSE, a randomized, double-blind, 52-week study (NCT03085797), included patients with severe bilateral chronic rhinosinusitis with NP eligible for surgery despite intranasal corticosteroid treatment. Patients received 4-weekly subcutaneous mepolizumab 100 mg or placebo plus standard of care for 52 weeks. Coprimary end points were change in total endoscopic NP score (week 52) and nasal obstruction visual analog scale score (weeks 49-52). Subgroup analyses by comorbid asthma and AERD status, and post hoc by BEC, were exploratory. Results: Analyses included 407 patients (289 with asthma; 108 with AERD; 371 and 278 with BEC counts ≥150 or ≥300 cells/μL, respectively). The proportion of patients with greater than or equal to 1-point improvement from baseline in NP score was higher with mepolizumab versus placebo across comorbid diseases (asthma: 52.9% vs 29.5%; AERD: 51.1% vs 20.6%) and baseline BEC subgroups (<150 cells/μL: 55.0% vs 31.3%; ≥150 cells/μL: 49.5% vs 28.1%; <300 cells/μL: 50.7% vs 29.0%; ≥300 cells/μL: 50.4% vs 28.1%). A similar trend was observed in patients without comorbid asthma or AERD. More patients had more than 3-point improvement in nasal obstruction VAS score with mepolizumab versus placebo across comorbid subgroups. Conclusions: Mepolizumab reduced polyp size and nasal obstruction in chronic rhinosinusitis with NP regardless of the presence of comorbid asthma or AERD.",
keywords = "AERD, Asthma, biologic therapy, blood eosinophils, chronic rhinosinusitis, mepolizumab, nasal polyps, sinus surgery, type 2 inflammation",
author = "Claus Bachert and Sousa, {Ana R.} and Han, {Joseph K.} and Schlosser, {Rodney J.} and Sowerby, {Leigh J.} and Claire Hopkins and Maspero, {Jorge F.} and Smith, {Steven G.} and Oliver Kante and Karidi-Andrioti, {Despina E.} and Bhabita Mayer and Chan, {Robert H.} and Yancey, {Steve W.} and Chaker, {Adam M.}",
note = "Funding Information: This study was funded by GlaxoSmithKline (GSK ID: 205687; ClinicalTrials.gov: NCT03085797). A.R.S., S.G.S., O.K., D.E.K.-A., B.M., R.H.C., and S.W.Y. are employees of GSK and contributed to the design of the study, the analysis and interpretation of data, writing the manuscript, and the decision to submit the manuscript for publication. Editorial support (in the form of writing assistance, including preparation of the draft manuscript under the direction and guidance of the authors, collating and incorporating authors{\textquoteright} comments for each draft, assembling tables and figures, grammatical editing, and referencing) was provided by Katie Crossland, PhD, and Ciara Keogh, PhD, at Fishawack Indicia Ltd, part of Fishawack Health, UK, and was funded by GSK . Funding Information: Disclosure of potential conflict of interest: C. Bachert reports advisory board membership and speaker fees for ALK, AstraZeneca, GlaxoSmithKline (GSK), and Mylan. J. K. Han has received consultancy fees from Sanofi Genzyme, Regeneron, Genentech, AstraZeneca, GSK, and Gossamer Bio. R. J. Schlosser has received consultancy fees from Sanofi Genzyme, Regeneron, Genentech, AstraZeneca, GSK, Healthy Humming, Optinose, Stryker, and Medtronic. L. J. Sowerby has received research grants from AstraZeneca, Roche, GSK, and Optinose, consultancy fees from Olympus and Freudenberg Medical, and speaker honoraria or advisory board fees from Mylan, Medtronic, Sanofi, and GSK. C. Hopkins has received advisory board fees from Sanofi, AstraZeneca, Olympus, and GSK. J. F. Maspero has received consultancy fees from AstraZeneca, Sanofi, and Teva; speaker honoraria from GSK, Menarini, Novartis, and Uriach; and research grants from Novartis. A. R. Sousa, S. G. Smith, O. Kante, D. E. Karidi-Andrioti, B. Mayer, R. H. Chan, and S. W. Yancey are employees of GSK and own stocks/shares. A. M. Chaker has received research/clinical study grants via Technical University Munich (TUM) from ALK Abello, AstraZeneca, Bencard/Allergen Therapeutics, ASIT Biotech, LETI, Roche, Sanofi Genzyme, and EIT Health; speaker honoraria via TUM from Allergopharma, ALK Abello, AstraZeneca, Bencard/Allergen Therapeutics, ASIT Biotech, Immunotek, Lofarma, GSK, Novartis, LETI, Roche, Regeneron, Sanofi Genzyme, Zeller, and the European Institute of Technology; advisory board fees via TUM from Allergopharma, ALK Abello, AstraZeneca, Bencard/Allergen Therapeutics, GSK, Novartis, Regeneron, and Sanofi Genzyme; data safety monitoring board fees from Immunotek and Lofarma; is a board member of the German Allergy and Immunology Society, the German Society of Applied Allergology, and the Immunotherapy Interest Group for the European Academy of Allergy and Clinical Immunology; the past Chair for the Allergy and Clinical Immunology Board; and a past board member of the Biologics Working Group for the European Academy of Allergy and Clinical Immunology. Publisher Copyright: {\textcopyright} 2022 The Authors",
year = "2022",
month = may,
doi = "10.1016/j.jaci.2021.10.040",
language = "English",
volume = "149",
pages = "1711--1721.e6",
journal = "Journal of Allergy and Clinical Immunology",
issn = "0091-6749",
publisher = "MOSBY, INC",
number = "5",
}
