Children with uncontrolled, moderate-to-severe asthma had better long-term lung function when they were treated with dupilumab (Dupixent), a randomized study showed.
In the year-long trial, add-on dupilumab given to children ages 6-11 improved forced expiratory volume in 1 second (FEV1) by a pre-bronchodilator average of 0.06 liters at week 2 versus placebo (P=0.025), and by an average 0.17 liters at week 52 (P<0.0001), reported Leonard B. Bacharier, MD, of Vanderbilt University Medical Center in Nashville.
As he noted in his presentation at the CHEST conference, the annual meeting of the American College of Chest Physicians, similar benefits were seen in post-bronchodilator FEV1, with a mean difference of 0.09 liters at week 52 compared with placebo (P=0.015), as were several other measures of lung function.
“These findings indicate that dupilumab led to significant, rapid, and sustained improvements in multiple aspects of lung function in children ages 6 to 11 years,” Bacharier said. “Dupilumab may improve lung function in children age 6-11 years with uncontrolled, moderate-to-severe asthma and a type 2 inflammatory phenotype.”
Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, which are both key and central drivers of type 2 inflammation in multiple diseases.
“Asthma, the most prevalent chronic disease in children, can lead to abnormal lung function and be a risk factor for abnormal lung growth and chronic obstructive lung disease in adulthood,” Bacharier and colleagues explained in their abstract. “Type 2 inflammation is the most common driver of asthma in children.”
The researchers defined the type 2 phenotype as blood eosinophils of at least 150 cells/mcL or fractional exhaled nitric oxide of at least 20 parts per billion at baseline.
In the main LIBERTY ASTHMA VOYAGE trial, a phase III, double-blind, placebo controlled trial, add-on dupilumab every 2 weeks demonstrated significant improvements in percent predicted pre-bronchodilator FEV1 by an additional 5.21 percentage points compared with placebo at week 12. The trial enrolled children diagnosed with uncontrolled, moderate-to-severe asthma and a type 2 inflammatory asthma phenotype.
For the current report, the researchers assessed additional lung parameters over the course of 52 weeks, Bacharier reported. Of the 408 children recruited for the trial, 350 met the type 2 phenotype criteria, and 236 were assigned to receive dupilumab, while 114 of the children were assigned to receive placebo.
Bacharier disclosed relationships with AstraZeneca, GlaxoSmithKline, Regeneron, Sanofi, CF Foundation, DBV Technologies, and Vectura.