Dupilumab efficacy in subgroups of type 2 asthma with high-dose inhaled corticosteroids at baseline.


Journal

Respiratory medicine
ISSN: 1532-3064
Titre abrégé: Respir Med
Pays: England
ID NLM: 8908438

Informations de publication

Date de publication:
10 2022
Historique:
received: 17 03 2022
revised: 01 07 2022
accepted: 17 07 2022
pubmed: 11 9 2022
medline: 28 9 2022
entrez: 10 9 2022
Statut: ppublish

Résumé

Dupilumab blocks the shared receptor component for interleukin (IL)-4/IL-13, key and central drivers of type 2 inflammation in multiple diseases. In phase 3 QUEST (NCT02414854), add-on dupilumab 200 and 300 mg every 2 weeks reduced severe exacerbations, improved pre-bronchodilator forced expiratory volume in 1 s (FEV Adjusted annualized severe exacerbation rates over the treatment period, least squares (LS) mean change from baseline at Week 12 in pre-bronchodilator FEV Dupilumab vs placebo reduced exacerbations and improved pre-bronchodilator FEV Dupilumab reduced severe exacerbations and improved lung function and asthma control in subgroups of patients with type 2 asthma and high-dose ICS at baseline. NCT02414854.

Sections du résumé

BACKGROUND AND OBJECTIVE
Dupilumab blocks the shared receptor component for interleukin (IL)-4/IL-13, key and central drivers of type 2 inflammation in multiple diseases. In phase 3 QUEST (NCT02414854), add-on dupilumab 200 and 300 mg every 2 weeks reduced severe exacerbations, improved pre-bronchodilator forced expiratory volume in 1 s (FEV
METHODS
Adjusted annualized severe exacerbation rates over the treatment period, least squares (LS) mean change from baseline at Week 12 in pre-bronchodilator FEV
RESULTS
Dupilumab vs placebo reduced exacerbations and improved pre-bronchodilator FEV
CONCLUSION
Dupilumab reduced severe exacerbations and improved lung function and asthma control in subgroups of patients with type 2 asthma and high-dose ICS at baseline.
CLINICAL TRIAL REGISTRATION NUMBER
NCT02414854.

Identifiants

pubmed: 36087550
pii: S0954-6111(22)00203-7
doi: 10.1016/j.rmed.2022.106938
pii:
doi:

Substances chimiques

Adrenal Cortex Hormones 0
Anti-Asthmatic Agents 0
Antibodies, Monoclonal, Humanized 0
Bronchodilator Agents 0
Interleukin-13 0
dupilumab 420K487FSG

Banques de données

ClinicalTrials.gov
['NCT02414854']

Types de publication

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

Langues

eng

Sous-ensembles de citation

IM

Pagination

106938

Informations de copyright

Copyright © 2022. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Declaration of competing interest Bourdin A: GSK – non-financial support during the conduct of the study; Acceleron Pharma, Actelion, Galapagos, Merck Sharp & Dohme, Nuvaira, Pulmonx, United Therapeutics, Vertex Pharmaceuticals – other; Boehringer Ingelheim – grants, personal fees; AstraZeneca, Chiesi, GSK, Regeneron Pharmaceuticals, Inc., Sanofi – personal fees. Virchow JC: Altana, AstraZeneca, Avontec, Bayer, Bencard Allergie, Bionorica, Boehringer Ingelheim, Chiesi, Essex Pharma Development, GSK, Hexal, Janssen-Cilag, Leti, Meda Pharmaceuticals, Merck, MSD, Mundipharma, Novartis, Nycomed, Pfizer, Revotar Biopharmaceuticals, Sandoz, Stallergenes Greer, Schwarz Pharma, Teva, UCB, Zydus Cadila – honoraria. Avontec, Boehringer Ingelheim, Chiesi, Essex Pharma Development, GSK, Hexal, Janssen-Cilag, Meda Pharmaceuticals, MSD, Mundipharma, Novartis, Regeneron Pharmaceuticals, Inc., Revotar Biopharmaceuticals, Roche, sanofi-aventis, Sandoz, Schwarz Pharma, Teva, UCB – advisory board participant. Deutsche Forschungsgesellschaft, GSK, Land Mecklenburg-Vorpommern, MSD – research grants. Papi A: AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Mundipharma, Teva – report grants, personal fees, nonfinancial support, other; Menarini, Novartis, Zambon – personal fees, nonfinancial support; Sanofi – grants (all outside the submitted work). Lugogo NL: Amgen, AstraZeneca, Avillion, Genentech, Gossamer Bio, GSK, Regeneron Pharmaceuticals, Inc., Sanofi, Teva − research support paid to institution; Amgen, AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi, Teva − advisory board member, consultant; AstraZeneca – travel support; AstraZeneca, GSK – honoraria for non-speaker's bureau presentations. Bardin P: AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Sanofi – consultant, speaker fees. Antila M: AbbVie, Angion Biomedica Corp, AstraZeneca, BeiGene, EMS, Eurofarma, GSK, Humanigen, Janssen, Novartis, Sanofi – clinical trial funding; Aché, AstraZeneca, Chiesi, Eurofarma, IPI ASAC Brasil, Sanofi – honoraria; AstraZeneca, GSK, Novartis, Sanofi – meeting or travel support; Abbott, AstraZeneca, Chiesi, Sanofi, Zambon – data safety monitoring board and/or advisory board member. Halpin DMG: AstraZeneca, Boehringer Ingelheim, Chiesi, CSL Behring, GSK, Novartis, Pfizer, Sandoz, Sanofi – advisory board member, speaker fees. Daizadeh N: Sanofi – former employee, may hold stock and/or stock options in the company. Djandji M, Jacob-Nara JA, Rowe PJ: Sanofi − employees, may hold stock and/or stock options in the company. Ortiz B: Regeneron – former employee, may hold stock and/or stock options in the company. Gall R, Deniz Y: Regeneron Pharmaceuticals, Inc. – employees and shareholders.

Auteurs

Arnaud Bourdin (A)

Department of Respiratory Disease, University of Montpellier, Montpellier University Hospital, Hôpital Arnaud de Villeneuve, 371 avenue du Doyen Gaston Giraud, 34295, Montpellier, Cedex 5, France. Electronic address: a-bourdin@chu-montpellier.fr.

J Christian Virchow (JC)

Universitätsmedizin Rostock, Abteilungen für Pneumologie und Internistische Intensivmedizin, Ernst-Heydemannstrasse 6, 18055, Rostock, Germany. Electronic address: j.c.virchow@med.uni-rostock.de.

Alberto Papi (A)

Respiratory Medicine Unit, University of Ferrara, S. Anna University Hospital, Azienda Ospedaliera S. Anna Corso Giovecca, 203, Ferrara, Italy. Electronic address: ppa@unife.it.

Njira L Lugogo (NL)

University of Michigan, 300 North Ingalls St Suite 2c40, Ann Arbor, MI, 48109, USA. Electronic address: nlugogo@med.umich.edu.

Philip Bardin (P)

Monash University, 27-31 Wright St, Clayton, VIC, 3168, Australia; Monash Medical Centre, 27-31 Wright St, Clayton, VIC, 3168, Australia. Electronic address: philip.bardin@monashhealth.org.au.

Martti Antila (M)

Clínica de Alergía, R. Duque de Caxias, 119 - Vila Leao, Sorocaba, SP, 18040-425, Brazil. Electronic address: martti.antila@cmpc.med.br.

David M G Halpin (DMG)

University of Exeter Medical School, College of Medicine and Health, University of Exeter, B3183, Exeter, EX1 2HZ, Devon, EX1 2LU, UK. Electronic address: d.halpin@nhs.net.

Nadia Daizadeh (N)

Sanofi, Cambridge, MA, USA. Electronic address: nadiadaizadeh@gmail.com.

Michel Djandji (M)

Sanofi, Cambridge, MA, USA. Electronic address: Michel.Djandji@sanofi.com.

Benjamin Ortiz (B)

Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd., Tarrytown, NY, 10591, USA. Electronic address: benjamin.ortiz.md@gmail.com.

Juby A Jacob-Nara (JA)

Sanofi, 55 Corporate Dr., Bridgewater Township, NJ, 08807, USA. Electronic address: Juby.Jacob-Nara@sanofi.com.

Rebecca Gall (R)

Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd., Tarrytown, NY, 10591, USA. Electronic address: Rebecca.Gall@Regeneron.com.

Yamo Deniz (Y)

Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd., Tarrytown, NY, 10591, USA. Electronic address: yamo.deniz@regeneron.com.

Paul J Rowe (PJ)

Sanofi, 55 Corporate Dr., Bridgewater Township, NJ, 08807, USA. Electronic address: Paul.Rowe@sanofi.com.

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Classifications MeSH