Mepolizumab for chronic rhinosinusitis with nasal polyps: Treatment efficacy by comorbidity and blood eosinophil count.


Journal

The Journal of allergy and clinical immunology
ISSN: 1097-6825
Titre abrégé: J Allergy Clin Immunol
Pays: United States
ID NLM: 1275002

Informations de publication

Date de publication:
05 2022
Historique:
received: 27 06 2021
revised: 12 10 2021
accepted: 28 10 2021
pubmed: 11 1 2022
medline: 11 5 2022
entrez: 10 1 2022
Statut: ppublish

Résumé

In the phase III SYNAPSE study, mepolizumab reduced nasal polyp (NP) size and nasal obstruction in chronic rhinosinusitis with NP. 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). 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. 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. Mepolizumab reduced polyp size and nasal obstruction in chronic rhinosinusitis with NP regardless of the presence of comorbid asthma or AERD.

Sections du résumé

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.

Identifiants

pubmed: 35007624
pii: S0091-6749(22)00001-X
doi: 10.1016/j.jaci.2021.10.040
pii:
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
mepolizumab 90Z2UF0E52

Banques de données

ClinicalTrials.gov
['NCT03085797']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1711-1721.e6

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

Auteurs

Claus Bachert (C)

Upper Airways Research Laboratory and Department of Oto-Rhino-Laryngology, Ghent University and Ghent University Hospital, Ghent, Belgium; Division of ENT Diseases, CLINTEC, Karolinska Institute, University of Stockholm, Stockholm, Sweden; First Affiliated Hospital, Sun Yat-sen University, International Airway Research Center, Guangzhou, China.

Ana R Sousa (AR)

Clinical Sciences, GSK R&D, Brentford, United Kingdom.

Joseph K Han (JK)

Department of Otolaryngology, Head & Neck Surgery, Eastern Virginia Medical School, Norfolk, Va.

Rodney J Schlosser (RJ)

Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.

Leigh J Sowerby (LJ)

Department of Otolaryngology-Head and Neck Surgery, Western University, London, Ontario, Canada.

Claire Hopkins (C)

ENT Department, Guys and St Thomas's Hospital, and King's College, London, United Kingdom.

Jorge F Maspero (JF)

Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.

Steven G Smith (SG)

Respiratory Therapeutic Area Unit, GSK, Research Triangle Park, NC.

Oliver Kante (O)

Global Clinical Sciences and Delivery, GSK, Munich, Germany.

Despina E Karidi-Andrioti (DE)

Global Clinical Sciences and Delivery, GSK, Brentford, United Kingdom.

Bhabita Mayer (B)

Clinical Statistics, GSK, Brentford, United Kingdom.

Robert H Chan (RH)

Clinical Sciences, GSK R&D, Brentford, United Kingdom.

Steve W Yancey (SW)

Clinical Statistics, GSK, Brentford, United Kingdom.

Adam M Chaker (AM)

Technical University of Munich, TUM School of Medicine, Klinikum rechts der Isar, Department of Otolaryngology and Center for Allergy and Environment, Munich, Germany. Electronic address: adam.chaker@tum.de.

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