New England Journal of Medicine publishes positive phase III Dupixent results in children with moderate-to-severe asthma.- Regeneron + Sanofi

These data formed the basis for the FDA approval of Dupixent on October 20, 2021 as an add-on maintenance treatment of patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

These published results showed Dupixent, when added to standard of care, significantly reduced severe asthma attacks and, within two weeks, rapidly improved lung function in populations with an eosinophilic phenotype, as indicated by elevated blood eosinophils, a certain type of white blood cell, and/or with elevated fractional exhaled nitric oxide (FeNO), an airway biomarker of inflammation that plays a major role in asthma.

"The publication of these Phase III results for Dupixent in the New England Journal of Medicine underscore their significance and potential clinical value for younger children with uncontrolled moderate-to-severe asthma," said Leonard B. Bacharier, M.D., Professor of Pediatrics and Director of the Center for Pediatric Asthma Research, Monroe Carell Jr. Children's Hospital at Vanderbilt University Medical Center in Nashville, Tennessee, and principal investigator of the trial. "These data also further our understanding of how addressing type 2 inflammation, a biological process that underlies most cases of childhood asthma, can potentially improve symptoms and outcomes for children suffering from this common chronic disease."

The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma, with the addition of helminth infections that were reported in 2.2% of Dupixent patients and 0.7% of placebo patients. The overall rates of adverse events were 83% for Dupixent and 80% for placebo. The most common adverse events that were more commonly observed with Dupixent compared to placebo were injection site reactions (18% Dupixent, 13% placebo), viral upper respiratory tract infections (12% Dupixent, 10% placebo) and eosinophilia (6% Dupixent, 1% placebo).

See- "Dupilumab in Children with Uncontrolled Moderate-to-Severe Asthma": Leonard B. Bacharier, M.D., Jorge F. Maspero, M.D., Constance H. Katelaris, M.D., ., et al., for the Liberty Asthma VOYAGE Investigators; December 9, 2021. N Engl J Med 2021; 385:2230-2240. DOI: 10.1056/NEJMoa2106567.