Available online 11 December 2023

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 FEV1 [ppFEV1] <80%) at baseline. Dupilumab improved pre- and post-bronchodilator ppFEV1 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% 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 post-bronchodilator forced vital capacity (FVC), pre-bronchodilator forced expiratory flow, and FEV1/FVC ratio across all populations.

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.

© 2023 Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology