Dupilumab Is Effective in Patients With Moderate-to-Severe Uncontrolled GINA-Defined Type 2 Asthma Irrespective of an Allergic Asthma Phenotype.


Journal

The journal of allergy and clinical immunology. In practice
ISSN: 2213-2201
Titre abrégé: J Allergy Clin Immunol Pract
Pays: United States
ID NLM: 101597220

Informations de publication

Date de publication:
11 2022
Historique:
received: 30 09 2021
revised: 15 06 2022
accepted: 16 06 2022
pubmed: 27 8 2022
medline: 15 11 2022
entrez: 26 8 2022
Statut: ppublish

Résumé

The Global Initiative for Asthma report recommends consideration of add-on biologics for patients with type 2 inflammation (blood eosinophils ≥150 cells/μL, fractional exhaled nitric oxide [Feno] ≥20 parts per billion or allergic asthma) whose asthma cannot be controlled by high-dose inhaled corticosteroids. In QUEST (NCT02414854), add-on dupilumab versus placebo was efficacious in patients with uncontrolled, moderate to severe asthma, including those with eosinophils greater than or equal to 150 cells/μL and/or Feno greater than or equal to 25 parts per billion. To assess dupilumab efficacy in patients with a type 2 phenotype in the presence or absence of allergic asthma phenotype. Patients aged 12 years or older received add-on dupilumab 200/300 mg versus matched placebo every 2 weeks for 52 weeks. Allergic asthma phenotype was defined as baseline serum total IgE greater than or equal to 30 IU/mL and 1 or more perennial aeroallergen-specific IgE level greater than or equal to 0.35 kU/L. Annualized rate of severe asthma exacerbations and changes from study baseline in prebronchodilator and postbronchodilator FEV Of 1902 patients in QUEST, 83.3% had eosinophils and/or Feno above Global Initiative for Asthma thresholds; 56.9% had evidence for allergic asthma. Dupilumab significantly reduced the rate of severe asthma exacerbations in patients with (48.8%) and without (64.0%) evidence of allergic asthma and improved prebronchodilator and postbronchodilator FEV In patients with type 2 biomarkers over Global Initiative for Asthma thresholds, dupilumab significantly reduced exacerbations and improved lung function. Efficacy was not impacted by allergic status.

Sections du résumé

BACKGROUND
The Global Initiative for Asthma report recommends consideration of add-on biologics for patients with type 2 inflammation (blood eosinophils ≥150 cells/μL, fractional exhaled nitric oxide [Feno] ≥20 parts per billion or allergic asthma) whose asthma cannot be controlled by high-dose inhaled corticosteroids. In QUEST (NCT02414854), add-on dupilumab versus placebo was efficacious in patients with uncontrolled, moderate to severe asthma, including those with eosinophils greater than or equal to 150 cells/μL and/or Feno greater than or equal to 25 parts per billion.
OBJECTIVE
To assess dupilumab efficacy in patients with a type 2 phenotype in the presence or absence of allergic asthma phenotype.
METHODS
Patients aged 12 years or older received add-on dupilumab 200/300 mg versus matched placebo every 2 weeks for 52 weeks. Allergic asthma phenotype was defined as baseline serum total IgE greater than or equal to 30 IU/mL and 1 or more perennial aeroallergen-specific IgE level greater than or equal to 0.35 kU/L. Annualized rate of severe asthma exacerbations and changes from study baseline in prebronchodilator and postbronchodilator FEV
RESULTS
Of 1902 patients in QUEST, 83.3% had eosinophils and/or Feno above Global Initiative for Asthma thresholds; 56.9% had evidence for allergic asthma. Dupilumab significantly reduced the rate of severe asthma exacerbations in patients with (48.8%) and without (64.0%) evidence of allergic asthma and improved prebronchodilator and postbronchodilator FEV
CONCLUSIONS
In patients with type 2 biomarkers over Global Initiative for Asthma thresholds, dupilumab significantly reduced exacerbations and improved lung function. Efficacy was not impacted by allergic status.

Identifiants

pubmed: 36028446
pii: S2213-2198(22)00651-1
doi: 10.1016/j.jaip.2022.06.036
pii:
doi:

Substances chimiques

dupilumab 420K487FSG
Immunoglobulin E 37341-29-0
Biomarkers 0
Anti-Asthmatic Agents 0

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

2916-2924.e4

Informations de copyright

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

Auteurs

Klaus F Rabe (KF)

Lungen Clinic Grosshansdorf (member of the German Center for Lung Research [DZL]), Airway Research Center North, Grosshansdorf, Germany; Christian-Albrechts University of Kiel (member of the German Center for Lung Research [DZL]), Airway Research Center North, Kiel, Germany. Electronic address: k.f.rabe@lungenclinic.de.

J Mark FitzGerald (JM)

The Centre for Lung Health, University of British Columbia, Vancouver, BC, Canada.

Eric D Bateman (ED)

University of Cape Town Lung Institute, Cape Town, South Africa; University of Cape Town, Cape Town, South Africa.

Mario Castro (M)

Division of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas School of Medicine, Kansas City, Kan.

Ian D Pavord (ID)

NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.

Jorge F Maspero (JF)

Allergy and Respiratory Medicine, Fundación CIDEA, Buenos Aires, Argentina.

William W Busse (WW)

UW Allergy, Pulmonary and Critical Care Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wis.

Kenji Izuhara (K)

Saga Medical School, Saga, Japan.

Nadia Daizadeh (N)

Sanofi, Cambridge, Mass.

Benjamin Ortiz (B)

Regeneron Pharmaceuticals, Inc, Tarrytown, NY.

Nami Pandit-Abid (N)

Sanofi, Bridgewater, NJ.

Paul J Rowe (PJ)

Sanofi, Bridgewater, NJ.

Yamo Deniz (Y)

Regeneron Pharmaceuticals, Inc, Tarrytown, NY.

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Classifications MeSH