Dupilumab Improves Lung Function Parameters in Pediatric Type 2 Asthma: VOYAGE study.

Asthma control Dupilumab Lung function Pediatric asthma Type 2 Inflammation

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 Dec 2023
Historique:
received: 21 07 2023
revised: 22 11 2023
accepted: 03 12 2023
medline: 14 12 2023
pubmed: 14 12 2023
entrez: 13 12 2023
Statut: aheadofprint

Résumé

Uncontrolled asthma in growing children can impair lung growth that may lead to adverse complications in later life. Dupilumab, a human monoclonal antibody, blocks the shared receptor for interleukins 4 and 13, key drivers of type 2 inflammation. To extensively evaluate the effect of dupilumab on lung function in children (6-11 years) with moderate-to-severe asthma enrolled in phase 3 LIBERTY ASTHMA VOYAGE (NCT02948959). Children with asthma were randomized 2:1 to add-on dupilumab 200/100 mg by bodyweight or placebo every 2 weeks, for 52 weeks. We analyzed spirometry parameters in children with type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 parts per billion [ppb] at baseline), and within subgroups defined by baseline blood eosinophils or FeNO values. 116 (49%) of dupilumab-treated children and 59 (52%) on placebo had impaired lung function (pre-bronchodilator percent-predicted FEV Dupilumab led to significant, sustained lung function improvements across a range of lung function measures in children (6-11 years) with uncontrolled, moderate-to-severe type 2 asthma.

Sections du résumé

BACKGROUND BACKGROUND
Uncontrolled asthma in growing children can impair lung growth that may lead to adverse complications in later life. Dupilumab, a human monoclonal antibody, blocks the shared receptor for interleukins 4 and 13, key drivers of type 2 inflammation.
OBJECTIVES OBJECTIVE
To extensively evaluate the effect of dupilumab on lung function in children (6-11 years) with moderate-to-severe asthma enrolled in phase 3 LIBERTY ASTHMA VOYAGE (NCT02948959).
METHODS METHODS
Children with asthma were randomized 2:1 to add-on dupilumab 200/100 mg by bodyweight or placebo every 2 weeks, for 52 weeks. We analyzed spirometry parameters in children with type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 parts per billion [ppb] at baseline), and within subgroups defined by baseline blood eosinophils or FeNO values.
RESULTS RESULTS
116 (49%) of dupilumab-treated children and 59 (52%) on placebo had impaired lung function (pre-bronchodilator percent-predicted FEV
CONCLUSIONS CONCLUSIONS
Dupilumab led to significant, sustained lung function improvements across a range of lung function measures in children (6-11 years) with uncontrolled, moderate-to-severe type 2 asthma.

Identifiants

pubmed: 38092225
pii: S2213-2198(23)01352-1
doi: 10.1016/j.jaip.2023.12.006
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT02948959']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Auteurs

Leonard B Bacharier (LB)

Division of Allergy, Immunology and Pulmonary Medicine, Monroe Carell Jr Children's Hospital at Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: leonard.bacharier@vumc.org.

Theresa W Guilbert (TW)

Cincinnati Children's Hospital and University of Cincinnati, Cincinnati, OH, USA.

Constance H Katelaris (CH)

Campbelltown Hospital, Campbelltown, NSW, Australia, and Western Sydney University, Sydney, NSW, Australia.

Antoine Deschildre (A)

University Lille, CHU Lille, University Hospital, and Pediatric Pulmonology and Allergy Department, Hôpital Jeanne de Flandre Hospital, Lille, France.

Wanda Phipatanakul (W)

Department of Allergy and Immunology, Boston Children's Hospital, Boston, MA, USA; Department of Pediatrics, Harvard Medical School, Boston, MA, USA.

Dongfang Liu (D)

Sanofi, Beijing, China.

Arman Altincatal (A)

Sanofi, Cambridge, MA, USA.

Leda P Mannent (LP)

Sanofi, Gentilly, France.

Nikhil Amin (N)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Elizabeth Laws (E)

Sanofi, Bridgewater, NJ, USA.

Bolanle Akinlade (B)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Juby A Jacob-Nara (JA)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Yamo Deniz (Y)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Paul J Rowe (PJ)

Sanofi, Bridgewater, NJ, USA.

David J Lederer (DJ)

Regeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Megan Hardin (M)

Sanofi, Cambridge, MA, USA.

Classifications MeSH