Dupilumab in children with uncontrolled moderate-to-severe asthma
New England Journal of Medicine — Bacharier LB, Maspero JF, Katelaris CH, et al. | December 10, 2021
Treatment with add-on dupilumab (monoclonal antibody) was associated with fewer asthma exacerbations and better lung function and asthma control than placebo in children with uncontrolled moderate-to-severe asthma.
A 52-week phase 3, randomized, double-blind, placebo-controlled trial of 408 children with uncontrolled moderate-to-severe asthma randomized to a subcutaneous injection of dupilumab or matched placebo every 2 weeks; all patients continued to receive a stable dose of standard background therapy.
Among those with type 2 inflammatory phenotype, the annualized rate of severe asthma exacerbations was 0.31 and 0.75 with dupilumab and with placebo, respectively (relative risk reduction in the dupilumab group, 59.3%).
Dupilumab-induced mean (±SE) change from baseline in the percentage of predicted prebronchodilator forced expiratory volume in 1 second was 10.5±1.0 percentage points; it was 5.3±1.4 percentage points with placebo (mean difference, 5.2 percentage points).
Significantly better asthma control was achieved with dupilumab use vs placebo.
The two groups showed similar incidence of serious adverse events.