Dupilumab Efficacy in Children With Type 2 Asthma Receiving High- to Medium-Dose Inhaled Corticosteroids (VOYAGE)
Jorge Máspero, Martti Antila, A. Deschildre, Leonard B. Bacharier, Arman Altincatal, Elizabeth Laws, Eric Mortensen, Amr Radwan, Juby A. Jacob‐Nara, Yamo Deniz, Paul J. Rowe, David J. Lederer, Megan Hardin
Abstract
Background In phase 3 VOYAGE (NCT02948959; Evaluation of Dupilumab in Children With Uncontrolled Asthma), dupilumab showed clinical efficacy with an acceptable safety profile in children aged 6 to 11 years with uncontrolled moderate to severe type 2 asthma (blood eosinophils ≥150 cells/μL or FeNO ≥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. End points were annualized severe exacerbation rate, changes from baseline in percent predicted FEV 1 , and seven-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-dose (n = 152) or medium-dose (n = 195) ICS at baseline, dupilumab versus placebo reduced severe exacerbation rates by 63% ( P < .001) and 59% ( P = .003), respectively. At week 52, dupilumab improved percent predicted FEV 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.