Dupilumab reduces severe exacerbations in children regardless of atopic comorbidities
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SAN FRANCISCO — Dupilumab reduced severe exacerbations and improved prebronchodilator FEV1 in children aged 6 to 11 years with uncontrolled moderate to severe asthma with or without ongoing atopic comorbidities, according to new data.
Theresa W. Guilbert, MD, MS, pediatric pulmonologist at Cincinnati Children’s Hospital and the University of Cincinnati, reported results of a post hoc analysis of the phase 3 LIBERTY ASTHMA VOYAGE study at the American Thoracic Society International Conference. The researchers assessed efficacy of dupilumab (Dupixent, Sanofi/Regeneron) in children with and without one or more ongoing atopic comorbidities, including atopic dermatitis, allergic conjunctivitis, allergic rhinitis, chronic rhinosinusitis, nasal polyposis, eosinophilic esophagitis, food allergy and hives.
“In children aged 6 to 11 years with uncontrolled moderate to severe asthma, dupilumab vs. placebo reduced severe asthma exacerbation rates by the end of treatment in participants with atopic dermatitis, food allergy and allergic rhinitis,” Guilbert said. “Dupilumab vs. placebo improved percent predicted prebronchodilator FEV1 and asthma control in participants with atopic dermatitis, food allergy and allergic rhinitis.”
The analysis included 408 children aged 6 to 11 years with uncontrolled moderate to severe asthma and self-reported atopic comorbidities at baseline. Overall, 171 children reported ongoing atopic dermatitis, 92 reported ongoing food allergy, 341 reported ongoing allergic rhinitis and 141 reported different combinations of atopic comorbidities.
The primary outcomes were annualized severe asthma exacerbation rates, change from baseline prebronchodilator FEV1 percent predicted and change from baseline asthma control measured by the Asthma Control Questionnaire-7.
Dupilumab reduced severe exacerbation rates regardless of atopic comorbid disease, with a 60% reduction among children without ongoing atopic comorbid disease, 66% reduction among children with atopic dermatitis, 56% reduction among children with allergic rhinitis and a 56% reduction among children with food allergy, Guilbert said during the presentation.
From baseline, change in prebronchodilator FEV1 percent predicted significantly improved in children with atopic dermatitis (76% and 49%) and allergic rhinitis (77% and 79%) at weeks 12 and 52 and improved in children with food allergy by week 52 (70%).
Researchers observed no significant difference in Asthma Control Questionnaire-7 scores between those assigned dupilumab or placebo. When looking at scores by atopic comorbidities, children with atopic dermatitis (2.01), allergic rhinitis (2.14) or food allergy (2.20) had significant improvements in mean asthma control scores at weeks 12 and 52.