Dupilumab Efficacy and Safety in Children With Moderate to Severe Asthma and High Blood Eosinophils: A Post Hoc Analysis of VOYAGE.

BACKGROUND

Elevated blood or tissue eosinophils are considered to characterize type 2 inflammation in children with asthma and are associated with increased exacerbation rates and worse asthma control. Dupilumab, a human mAb that blocks type 2 inflammatory drivers IL-4 and IL-13, reduced severe exacerbation rates and improved lung function versus placebo in children aged 6 to 11 years with uncontrolled moderate to severe asthma in the phase 3 LIBERTY ASTHMA VOYAGE study (NCT02948959).

OBJECTIVE

To assess dupilumab efficacy and safety in children from VOYAGE with moderate to severe asthma and greater than or equal to 500 and less than 1500 blood eosinophils/μL at baseline.

METHODS

Children received add-on dupilumab (100/200 mg by body weight) or matched placebo every 2 weeks for 52 weeks. We assessed annualized severe exacerbation rates, least squares mean change from baseline in prebronchodilator percent predicted FEV, and incidence of treatment-emergent adverse events.

RESULTS

In children with elevated baseline eosinophils (N = 174), dupilumab versus placebo significantly reduced annualized exacerbation rates by 67% (95% CI, 38%-82%; P < .001) and improved prebronchodilator percent predicted FEV from baseline at weeks 24 and 52 (week 24 least squares mean difference, 7.58 percentage points; 95% CI, 2.85-12.31; P = .002; week 52 least squares mean difference, 7.98 percentage points; 95% CI, 2.17-13.78; P = .007). The incidence of treatment-emergent adverse events was similar with dupilumab and placebo.

CONCLUSIONS

Dupilumab significantly reduced severe exacerbations and improved lung function in children with moderate to severe asthma and baseline blood eosinophil counts greater than or equal to 500 and less than 1500 cells/μL, with a safety profile comparable with the overall study population.