Sanofi and Regeneron’s Dupixent (dupilumab) has demonstrated significant improvements in paediatric patients with eosinophilic oesophagitis (EoE), according to phase 3 results published in the New England Journal of Medicine.
Affecting approximately one in 2,000 people in the US, EoE is a chronic inflammatory disease that results in a range of symptoms, including difficulty swallowing, vomiting and pain.
Already approved to treat certain EoE patients, Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways associated with type 2 inflammation.
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.”
Dupixent was approved by the US Food and Drug Administration in January to treat EoE in paediatric patients aged one to 11 years and weighing at least 15kg, and the therapy is currently under review by the European Medicines Agency for this age group.
Beyond EoE, Dupixent holds approvals to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria and chronic obstructive pulmonary disease.