Dupilumab Efficacy in Children With Type 2 Asthma Receiving High/Medium-Dose ICS (VOYAGE).

Autor: Maspero JF; Fundación CIDEA, Buenos Aires, Argentina. Electronic address: jorge.maspero@fundacioncidea.org.ar., Antila MA; Clínica de Alergía, Sorocaba, Sao Paulo, Brazil., Deschildre A; University Lille, CHU Lille, Pediatric Pulmonology and Allergy Department, Hôpital Jeanne de Flandre, 59000 Lille, France., Bacharier LB; Division of Allergy, Immunology and Pulmonary Medicine, Monroe Carell Jr Children's Hospital at Vanderbilt University Medical Center, Nashville, Tenn., Altincatal A; Sanofi, Cambridge, Mass., Laws E; Sanofi, Bridgewater, NJ., Mortensen E; Regeneron Pharmaceuticals Inc., Tarrytown, NY., Radwan A; Regeneron Pharmaceuticals Inc., Tarrytown, NY., Jacob-Nara JA; Sanofi, Bridgewater, NJ., Deniz Y; Regeneron Pharmaceuticals Inc., Tarrytown, NY., Rowe PJ; Sanofi, Bridgewater, NJ., Lederer DJ; Regeneron Pharmaceuticals Inc., Tarrytown, NY., Hardin M; Sanofi, Cambridge, Mass.
Jazyk: angličtina
Zdroj: The journal of allergy and clinical immunology. In practice [J Allergy Clin Immunol Pract] 2024 Aug 27. Date of Electronic Publication: 2024 Aug 27.
DOI: 10.1016/j.jaip.2024.08.038
Abstrakt: Background: In phase 3 VOYAGE (NCT02948959), dupilumab showed clinical efficacy with an acceptable safety profile in children (6-11 years) with uncontrolled, moderate-to-severe type 2 asthma (blood eosinophils ≥150 cells/μL or fractional exhaled nitric oxide ≥20 ppb).
Objective: We analyzed dupilumab's efficacy in children with type 2 asthma by high- or medium-dose inhaled corticosteroids (ICS) at baseline.
Methods: Children were randomized to receive add-on dupilumab 100/200 mg (by body-weight ≤30 kg/>30 kg) every 2 weeks or placebo for 52 weeks and stratified by high- or medium-dose ICS at baseline. Endpoints were annualized severe exacerbation rate, changes from baseline in percent-predicted forced expiratory volume in 1 second (ppFEV 1 ) and 7-item Asthma Control Questionnaire - Interviewer Administered (ACQ-7-IA) score, proportions of ACQ-7-IA responders (improvement ≥0.5), and biomarker changes.
Results: In children receiving high- (n = 152) or medium- (n = 195) dose ICS at baseline, dupilumab versus placebo reduced severe exacerbation rates by 63% (P < .001) and 59% (P = .003), respectively. At week 52, dupilumab improved ppFEV 1 by least squares mean difference versus placebo of 5.7 percentage points (P = .02) and 9.35 points (P < .001), and reduced ACQ-7-IA scores by 0.53 points (P < .001) and 0.40 points (P < .001), respectively. No significant treatment interactions between ICS subgroups were detected at week 52. Significant improvements were observed in ACQ-7-IA responder rates and most type 2 biomarker levels.
Conclusion: Dupilumab reduced severe exacerbation rates and improved lung function and asthma control in children with uncontrolled, moderate-to-severe type 2 asthma, regardless of ICS dose at baseline.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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