Background: The efficacy of dupilumab in children in the age group 6–11 years with type 2 asthma was reported in VOYAGE (NCT02948959) and the EXCURSION (NCT03560466) extension study. The aim of the study was to evaluate the efficacy of dupilumab in children with and without an early increase in eosinophils (<500 cells/µL at baseline and ≥500 cells/µL at VOYAGE Week 12).Methods: In VOYAGE, patients received add-on dupilumab 100/200 mg (based on body weight) or matched placebo every 2 weeks for 52 weeks; patients who completed the VOYAGE study were enrolled in the EXCURSION study and received dupilumab for 52 weeks (all patients). The endpoints estimated were severe exacerbation rates and change in total IgE.Results: There was a significant reduction in the severe exacerbation rates in the patients on dupilumab vs placebo. These reductions were maintained in EXCURSION, regardless of changes in eosinophils from baseline to Week 12 of VOYAGE (Figure). At Week 52 of VOYAGE, dupilumab reduced total IgE levels vs placebo in all patients (median [Q1−Q3]: children with eosinophil changes, 30 [−9 to 143 IU/mL] for placebo and −518 [−1097 to −162 IU/mL] for dupilumab; children without eosinophil changes, 3 [−64 to 110 IU/mL] for placebo and −369 [−870 to −136 IU/mL] for dupilumab). These findings were maintained through EXCURSION. The study findings were similar when eosinophils were stratified by <2- or ≥2-fold change from baseline to Week 12.Conclusions: Dupilumab reduced exacerbation rates and total IgE levels for up to 2 years in children with type 2 asthma vs placebo, irrespective of increased eosinophil count from baseline to VOYAGE Week 12.
