Dupilumab Plus Medium-Dose Inhaled Corticosteroid (ICS) Improves Outcomes Compared With Placebo Plus Continued High-Dose ICS in Children With Uncontrolled Moderate-to-Severe Type 2 Asthma.

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 (ppFEV), 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 ppFEV, 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.