Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Mar;13(3):568-575.
doi: 10.1016/j.jaip.2024.11.014. Epub 2024 Nov 28.

Dupilumab Efficacy and Safety in Children With Moderate to Severe Asthma and High Blood Eosinophils: A Post Hoc Analysis of VOYAGE

Daniel J Jackson  1 , Eckard Hamelmann  2 , Graham Roberts  3 , Leonard B Bacharier  4 , Changming Xia  5 , Rebecca Gall  5 , Olivier Ledanois  6 , Anna Coleman  5 , Kelsey Tawo  7 , Juby A Jacob-Nara  7 , Amr Radwan  5 , Paul J Rowe  7 , Yamo Deniz  5
Affiliations
Free article
Clinical Trial

Dupilumab Efficacy and Safety in Children With Moderate to Severe Asthma and High Blood Eosinophils: A Post Hoc Analysis of VOYAGE

Daniel J Jackson et al. J Allergy Clin Immunol Pract. 2025 Mar.
Free article

Abstract

Background: Elevated blood or tissue eosinophils are considered to characterize type 2 inflammation in children with asthma and are associated with increased exacerbation rates and worse asthma control. Dupilumab, a human mAb that blocks type 2 inflammatory drivers IL-4 and IL-13, reduced severe exacerbation rates and improved lung function versus placebo in children aged 6 to 11 years with uncontrolled moderate to severe asthma in the phase 3 LIBERTY ASTHMA VOYAGE study (NCT02948959).

Objective: To assess dupilumab efficacy and safety in children from VOYAGE with moderate to severe asthma and greater than or equal to 500 and less than 1500 blood eosinophils/μL at baseline.

Methods: Children received add-on dupilumab (100/200 mg by body weight) or matched placebo every 2 weeks for 52 weeks. We assessed annualized severe exacerbation rates, least squares mean change from baseline in prebronchodilator percent predicted FEV1, and incidence of treatment-emergent adverse events.

Results: In children with elevated baseline eosinophils (N = 174), dupilumab versus placebo significantly reduced annualized exacerbation rates by 67% (95% CI, 38%-82%; P < .001) and improved prebronchodilator percent predicted FEV1 from baseline at weeks 24 and 52 (week 24 least squares mean difference, 7.58 percentage points; 95% CI, 2.85-12.31; P = .002; week 52 least squares mean difference, 7.98 percentage points; 95% CI, 2.17-13.78; P = .007). The incidence of treatment-emergent adverse events was similar with dupilumab and placebo.

Conclusions: Dupilumab significantly reduced severe exacerbations and improved lung function in children with moderate to severe asthma and baseline blood eosinophil counts greater than or equal to 500 and less than 1500 cells/μL, with a safety profile comparable with the overall study population.

Keywords: Asthma; Dupilumab; Eosinophilia; Exacerbation; Percentage predicted FEV(1).

PubMed Disclaimer

Publication types

Associated data