HealthDay News — Children with uncontrolled moderate-to-severe asthma who receive adjuvant dupilumab rather than placebo have fewer asthma exacerbations, better lung function, and improved asthma control, according to a study published in the Dec. 9 issue of the New England Journal of Medicine.
Leonard B. Bacharier, M.D., from Monroe Carell Jr. Children’s Hospital at Vanderbilt in Nashville, Tennessee, and colleagues conducted a 52-week randomized trial involving 408 children, ages 6 to 11 years, with uncontrolled moderate-to-severe asthma. Participants were randomly assigned to receive a subcutaneous injection of either dupilumab or matched placebo every two weeks, in addition to continuing to receive a stable dose of background therapy.
The researchers found that the annualized rate of severe asthma exacerbations was 0.31 and 0.75 for dupilumab and placebo, respectively, in patients with the type 2 inflammatory phenotype (relative risk reduction in dupilumab group, 59.3 percent). The mean change from baseline in the percentage of predicted prebronchodilator forced expiratory volume in one second at week 12 was 10.5 ± 1.0 and 5.3 ± 1.4 percentage points with dupilumab and placebo, respectively (mean difference, 5.2 percentage points). Significantly better asthma control was seen with dupilumab versus placebo. Patients with an eosinophil count of at least 300 cells/mm3 at baseline had similar results. The two groups had a similar incidence of serious adverse events.
“Dupilumab therapy led to meaningful improvements through reductions in asthma exacerbations and rapid improvements in lung function and asthma control during the 52-week trial period,” the authors write.
The study was funded by Sanofi and Regeneron Pharmaceuticals, the manufacturers of dupilumab.