Dupilumab led to rapid, sustained improvements in lung function in children
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Dupilumab led to rapid and sustained improvements in lung function in children aged 6 to 11 years with uncontrolled moderate to severe asthma and a type 2 inflammatory phenotype, according to new data from the LIBERTY ASTHMA VOYAGE study.
Add-on dupilumab (Dupixent, Sanofi/Regeneron) every 2 weeks, compared with placebo, significantly improved pre-bronchodilator FEV1 during 52 weeks of treatment. Children receiving dupilumab experienced rapid improvements by week 2 and this was sustained for up to 52 weeks (least-squares mean difference vs. placebo, 0.17 L; P < .0001), Leonard B. Bacharier, MD, professor of pediatrics at Monroe Carell Jr. Children’s Hospital at Vanderbilt University, said during a virtual presentation at the CHEST Annual Meeting.
Bacharier said similar improvements were observed in other lung function parameters at 52 weeks, including:
- post-bronchodilator FEV1 (least-squares [LS] mean difference vs. placebo, 0.09 L; P = .015);
- post-bronchodilator FEV1 percent predicted (LS mean difference vs. placebo, 4.37 percentage points; P = .012);
- pre-bronchodilator forced expiratory flow25%-75% (LS mean difference, 0.3 L/s; P < .0001);
- percent predicted FEF25%-75% (LS mean difference, 12.02 percentage points, P < .0001); and
- FVC (LS mean difference, 0.1 L; P = .007).
The prespecified analysis included 350 children who met the criteria for a type 2 inflammatory phenotype (blood eosinophils 150 cells/µL or fractional exhaled nitric oxide [FeNO] 20 ppb), from the overall population of 408 children with uncontrolled moderate to severe asthma aged 6 to 11 years enrolled in the phase 3 LIBERTY ASTHMA VOYAGE study. Children in the study received add-on dupilumab 200 mg or 100 mg based on body weight every 2 weeks or matching placebo for 52 weeks.
The new data come on the heels of the primary pediatric results of LIBERTY ASTHMA VOYAGE presented at the virtual American Thoracic Society International Conference in May. As Healio previously reported, dupilumab significantly reduced asthma exacerbations and improved lung function in the pediatric population. In other recent results reported by Healio, children receiving dupilumab also had improved asthma control and quality of life.