Lung Function Improved With Dupilumab in Adolescents With Asthma

This article is part of Pulmonology Advisor‘s coverage of the CHEST 2018 meeting, taking place in San Antonio, Texas. Our staff will report on medical research related to COPD, critical care medicine, and more conducted by experts in the field. Check back regularly for more news from CHEST 2018.

SAN ANTONIO — Dupilumab was associated with improvements in lung function in adolescents with moderate to severe asthma, according to results from a phase 3 study presented at the CHEST Annual Meeting, held October 6-10, 2018, in San Antonio, Texas.

Researchers conducted a prespecified analysis to evaluate the efficacy and safety of dupilumab in adolescents with asthma.

Patients with asthma age ≥12 years were randomly assigned to either dupilumab 200 mg or 300 mg or placebo every 2 weeks for a total of 52 weeks. The investigators assessed annualized rates of severe exacerbations using a negative binomial regression analysis. Additionally, the researchers evaluated the change from baseline in the prebronchodilator forced expiratory volume in 1 second (FEV₁) and percentage predicted FEV₁ at 12 weeks of treatment. A total of 1902 patients were enrolled in the study, with 34 adolescent patients enrolled in both dupilumab dose regimens and 21 enrolled in the placebo group.

At baseline, the mean FEV₁, predicted FEV₁, and severe exacerbations in the prior year were 2.33 L, 70.45%, and 1.91, respectively. Lower annualized rates of severe exacerbations were observed in the adolescents assigned to placebo vs adults assigned to placebo (0.36/0.33 vs 0.89/1.00, respectively). In adolescent patients, 200 mg dupilumab was associated with a 46.4% reduction in the annualized exacerbation rate, whereas 300 mg dupilumab did not demonstrate an effect compared with placebo. According to the investigators, this finding “may be due to the small sample size and an imbalance in the number of prior events (mean 1.53 vs 2.22 for dupilumab 300 mg vs [placebo]).”

The investigators observed significant improvements in the change from baseline FEV₁ at 12-week follow-up compared with placebo in adolescents treated with 200 mg dupilumab (0.36 [95% CI, 0.12-0.61]) and 300 mg dupilumab (0.27 [95% CI, 0.02-0.52]; P <.05). These changes were greater than those observed in adult patients (0.12; 95% CI, 0.07-0.18)) at both treatment doses. Injection site reactions were the most frequently reported adverse events (>10%) in patients randomly assigned to dupilumab vs placebo.

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Reference

Maspero J, FitzGerald M, Pavord I, et al. Dupilumab reduces severe exacerbation rate and improves lung function in adolescent patients with uncontrolled, moderate-to-severe asthma: from the Liberty Asthma Quest Study. Presented at: CHEST Annual Meeting 2018; October 6-10, 2018; San Antonio, TX.