WEDNESDAY, May 26, 2021 (HealthDay News) — Dupilumab reduces exacerbations in children with uncontrolled moderate-to-severe asthma, according to a study presented at the American Thoracic Society 2021 International Conference, held virtually from May 14 to 19.
Leonard B. Bacharier, M.D., from the Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center in Nashville, Tennessee, and colleagues enrolled 408 children ages 6 to 11 years with uncontrolled moderate-to-severe asthma who were receiving high-dose inhaled corticosteroids (ICS) alone or medium-to-high-dose ICS with a second asthma controller. Prespecified primary analyses were performed in two populations: 350 patients with markers of type 2 inflammation and 259 patients with baseline blood eosinophils ≥300 cells/µl. Participants were randomly assigned to receive either add-on subcutaneous dupilumab (100 or 200 mg every two weeks) or matched placebo in a 2:1 ratio.
The researchers found that for patients with a type 2 inflammatory asthma phenotype, compared with placebo, dupilumab reduced the exacerbation rate by 59.3 percent, improved forced expiratory volume in one second percent predicted (least squares mean difference, 5.21 percent), and reduced fractional exhaled nitric oxide (least squares mean difference, −17.84 ppb) at week 12. At week 24, the change in the Asthma Control Questionnaire-Interviewer Administered scores from baseline was greater for dupilumab versus placebo (least squares mean difference versus placebo, −0.33). Results were similar for patients with baseline blood eosinophils ≥300 cells/µl.
“The effect of dupilumab on improving lung function in these children was particularly impressive,” Bacharier in a statement. “Decreased lung function is associated with an increased risk of future asthma exacerbations. In addition, impaired lung function can result in abnormal lung growth. In this trial, dupilumab demonstrated significant and rapid improvement in lung function within two weeks that was sustained for up to 52 weeks, compared to placebo.”
The study was funded by Sanofi and Regeneron Pharmaceuticals, the manufacturers of dupilumab.
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