Lung Function Improved With Dupilumab in Adolescents With Asthma

In adolescents, 200mg dupilumab was associated with a 46.4% reduction in the annualized exacerbation rate.
In adolescents, 200mg dupilumab was associated with a 46.4% reduction in the annualized exacerbation rate.
This article is part of MPR's coverage of CHEST 2018 meeting, taking place in San Antonio, TX. Our on-site staff will be reporting on the latest breaking research and clinical advances in infectious diseases. Check back regularly for highlights from CHEST 2018 meeting.

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.

Patients with asthma age ≥12 years were randomly assigned to either dupilumab 200mg or 300mg 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.

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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.