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

Autor: Bacharier LB; Division of Allergy, Immunology and Pulmonary Medicine, Monroe Carell Jr Children's Hospital at Vanderbilt University Medical Center, Nashville, Tenn. Electronic address: leonard.bacharier@vumc.org., Guilbert TW; Cincinnati Children's Hospital and University of Cincinnati, Cincinnati, Ohio., Katelaris CH; Campbelltown Hospital, Campbelltown, NSW, Australia; Western Sydney University, Sydney, NSW, Australia., Deschildre A; CHU Lille, Lille University Hospital, Lille, France; Pediatric Pulmonology and Allergy Department, Hôpital Jeanne de Flandre Hospital, Lille, France., Phipatanakul W; Department of Allergy and Immunology, Boston Children's Hospital, Boston, Mass; Department of Pediatrics, Harvard Medical School, Boston, Mass., Liu D; Department of Immunology, Sanofi, Beijing, China., Altincatal A; Department of Immunology, Sanofi, Cambridge, Mass., Mannent LP; Department of Immunology, Sanofi, Gentilly, France., Amin N; Department of Medical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY., Laws E; Department of Immunology, Sanofi, Bridgewater, NJ., Akinlade B; Department of Medical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY., Jacob-Nara JA; Department of Medical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY., Deniz Y; Department of Medical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY., Rowe PJ; Department of Immunology, Sanofi, Bridgewater, NJ., Lederer DJ; Department of Medical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, NY., Hardin M; Department of Immunology, Sanofi, Cambridge, Mass.
Jazyk: angličtina
Zdroj: The journal of allergy and clinical immunology. In practice [J Allergy Clin Immunol Pract] 2024 Apr; Vol. 12 (4), pp. 948-959. Date of Electronic Publication: 2023 Dec 11.
DOI: 10.1016/j.jaip.2023.12.006
Abstrakt: 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 IL-4 and IL-13, key drivers of type 2 inflammation.
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: Children with asthma were randomized 2:1 to add-on dupilumab 100/200 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: A total of 116 (49%) dupilumab-treated children and 59 (52%) on placebo had impaired lung function (prebronchodilator percent-predicted forced expiratory volume in 1 second [ppFEV 1 ] <80%) at baseline. Dupilumab improved pre- and postbronchodilator ppFEV 1 as early as week 2, sustained for up to 52 weeks (least-squares mean difference vs placebo at week 52: 7.79 percentage points; 95% confidence interval [CI]: 4.36-11.22; P < .001 and 4.37 points; 95% CI: 0.95-7.78; P = .01, respectively). Sustained improvements were also observed in other lung function parameters, including pre- and postbronchodilator forced vital capacity (FVC), prebronchodilator forced expiratory flow, and FEV 1 /FVC ratio across all populations.
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.
(Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: