The late-stage study compared the therapy at a weight-tiered higher or lower dose regimen to placebo in patients aged one to 11 years with EoE. Following the 16-week treatment period in part A, eligible patients transitioned to the 36-week extended active treatment period in part B, in which those in the Dupixent group maintained their dose level and those in the placebo cohort switched to Dupixent.
Results showed that a significantly higher proportion of patients who were treated with a weight-tiered, higher- or lower-dose Dupixent regimen achieved histologic remission at week 16 compared to those in the placebo group.
Patients receiving a higher dose of Dupixent experienced significant improvements in disease severity, as assessed by endoscopic measures, with improvements sustained for up to one year. Those treated with a lower dose experienced improvements that were either comparable or lower than those in the higher dose group.
Dupixent also led to improvements in body weight for age percentile by week 16, which were sustained for one year, and safety results from the study were generally consistent with the known safety profile of the therapy in adolescents and adults with EoE.
Principal investigator, Mirna Chehade, the Icahn School of Medicine at Mount Sinai, said the results “reinforce the positive results seen in older patients with EoE and strengthen [the] understanding of IL4 and IL13 as key drivers of the type 2 inflammation underlying this disease.”