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Dupilumab Plus Medium-Dose Inhaled Corticosteroid (ICS) Improves Outcomes Compared With Placebo Plus Continued
Leonard B Bacharier1, Jorge F Maspero2, Nikolaos G Papadopoulos3
1Monroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Background:
Dupilumab improved clinical outcomes in children (aged 6-11 years) with moderate-to-severe asthma and type 2 inflammation (baseline blood eosinophil count ≥ 150 cells/μL or fractional exhaled nitric oxide [FeNO] ≥ 20 ppb) in the phase 3 VOYAGE study (NCT02948959). We evaluated dupilumab plus medium-dose ICS versus placebo plus continued high-dose ICS in children in VOYAGE.
Methods:
Children were randomized to dupilumab 100/200 mg by body weight or placebo every 2 weeks for 52 weeks. Annualized severe exacerbation rates, change from baseline in pre-bronchodilator percent predicted forced expiratory volume in 1 s (ppFEV1), morning peak expiratory flow (PEF), 7-item Asthma Control Questionnaire-Investigator Administered (ACQ-7-IA) score, FeNO, blood eosinophil count, and total IgE at Week 52 were assessed.
Results:
Data from 184 children were analyzed (dupilumab plus medium-dose ICS, n = 134; placebo plus high-dose ICS, n = 50). At Week 52, dupilumab plus medium-dose ICS versus placebo plus high-dose ICS significantly reduced exacerbations by 74.3%, and significantly improved ppFEV1, morning PEF, ACQ-7-IA score, FeNO, and total IgE. There was no significant difference in blood eosinophil counts between the two groups.
Conclusion:
In children with moderate-to-severe asthma and type 2 inflammation, treatment with dupilumab plus medium-dose ICS reduced exacerbations and improved lung function and asthma control compared with placebo plus continued high-dose ICS.
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