Children With Asthma Receiving Dupilumab Plus Medium-Dose Inhaled Corticosteroids Had Improved Exacerbations, Lung Function, and Airway Inflammation Compared To Those Receiving Placebo Plus High-Dose Inhaled Corticosteroids
Author(s)
Leonard B. Bacharier, MD1, Nikolaos G. Papadopoulos, MD2, Remi Gagnon, MD3, Theresa W. Guilbert, MD, MS4, Changming Xia, PhD5, Olivier LEDANOIS, MD6, Mena Soliman, MD, MSc5, Jorge F. Maspero, MD7.
1Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, TN, USA, 2Second Pediatric Clinic, University of Athens, Athens, Greece, 3Clinique Spécialisée en Allergie de la Capitale, Quebec, QC, Canada, 4Cincinnati Children’s Hospital and University of Cincinnati, Cincinnati, OH, USA, 5Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 6Sanofi, Paris, France, 7Fundación CIDEA, Buenos Aires, Argentina.
1Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, TN, USA, 2Second Pediatric Clinic, University of Athens, Athens, Greece, 3Clinique Spécialisée en Allergie de la Capitale, Quebec, QC, Canada, 4Cincinnati Children’s Hospital and University of Cincinnati, Cincinnati, OH, USA, 5Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA, 6Sanofi, Paris, France, 7Fundación CIDEA, Buenos Aires, Argentina.
OBJECTIVES: Asthma in children is commonly associated with the type 2 inflammatory phenotype; however, treatment of children with asthma with high-dose inhaled corticosteroids (ICS) may have adverse effects. Dupilumab is a human monoclonal antibody that blocks signaling of interleukin-4 and -13, which are central drivers of type 2 inflammation. Dupilumab reduced severe exacerbations and improved lung function in children with moderate-to-severe type 2 asthma in the phase 3 VOYAGE study (NCT02948959). This post hoc analysis aimed to compare the treatment efficacy of dupilumab plus medium-dose ICS vs placebo plus continued high-dose ICS.
METHODS: In VOYAGE, children with type 2 asthma (blood eosinophil counts ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 ppb) received dupilumab 100/200 mg by body weight or placebo every 2 weeks for 52 weeks. Endpoints included adjusted annualized severe exacerbation rates, change from baseline to Week 52 in z-score for pre-bronchodilator forced expiratory volume in 1 second (FEV1), and change from baseline to Week 52 in FeNO.
RESULTS: From baseline to Week 52, children receiving dupilumab plus medium-dose ICS (n=134) had significantly reduced adjusted annualized exacerbation rates by 74% (relative risk vs placebo [95% CI]: 0.257 [0.143, 0.463]; P<0.0001) and significantly improved z-scores from baseline for pre-bronchodilator FEV1 (least squares mean difference [95% CI] 0.84 [0.38, 1.29]; P=0.0004) vs children receiving placebo plus continued high-dose ICS (n=50). Significant reductions were also seen in FeNO (least squares mean difference [95% CI] −16.32 ppb [−21.34, −11.30]; P<0.0001) with dupilumab plus medium-dose ICS vs placebo plus high-dose ICS at Week 52.
CONCLUSIONS: In children with moderate-to-severe type 2 asthma, dupilumab plus medium-dose ICS significantly reduced exacerbations and improved lung function and airway inflammation vs placebo plus continued high-dose ICS.
METHODS: In VOYAGE, children with type 2 asthma (blood eosinophil counts ≥150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥20 ppb) received dupilumab 100/200 mg by body weight or placebo every 2 weeks for 52 weeks. Endpoints included adjusted annualized severe exacerbation rates, change from baseline to Week 52 in z-score for pre-bronchodilator forced expiratory volume in 1 second (FEV1), and change from baseline to Week 52 in FeNO.
RESULTS: From baseline to Week 52, children receiving dupilumab plus medium-dose ICS (n=134) had significantly reduced adjusted annualized exacerbation rates by 74% (relative risk vs placebo [95% CI]: 0.257 [0.143, 0.463]; P<0.0001) and significantly improved z-scores from baseline for pre-bronchodilator FEV1 (least squares mean difference [95% CI] 0.84 [0.38, 1.29]; P=0.0004) vs children receiving placebo plus continued high-dose ICS (n=50). Significant reductions were also seen in FeNO (least squares mean difference [95% CI] −16.32 ppb [−21.34, −11.30]; P<0.0001) with dupilumab plus medium-dose ICS vs placebo plus high-dose ICS at Week 52.
CONCLUSIONS: In children with moderate-to-severe type 2 asthma, dupilumab plus medium-dose ICS significantly reduced exacerbations and improved lung function and airway inflammation vs placebo plus continued high-dose ICS.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
CO41
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
Pediatrics, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)