Sanofi/Regeneron’s Dupixent significantly improves pediatric eosinophilic esophagitis

Sanofi and Regeneron's Dupixent (dupilumab) has shown notable improvements in pediatric patients suffering from eosinophilic esophagitis (EoE), based on phase 3 clinical trial results published in the New England Journal of Medicine. EoE, a chronic inflammatory condition affecting around one in 2,000 individuals in the United States, manifests through symptoms such as swallowing difficulties, vomiting, and pain.

Dupixent, already approved to treat specific EoE cases, is a fully human monoclonal antibody that targets and inhibits the signaling pathways of interleukin-4 (IL4) and interleukin-13 (IL13), both of which are involved in type 2 inflammation.

The late-phase study involved a comparison between a weight-tiered Dupixent dosage—either higher or lower—and a placebo in children aged one to 11. After an initial 16-week treatment period (part A), eligible participants entered a 36-week extended treatment phase (part B). Those originally on Dupixent continued with their assigned dose, while placebo participants switched to Dupixent.

The study revealed that a significantly greater number of patients on a weight-tiered Dupixent regimen, whether higher or lower dose, achieved histologic remission by week 16 compared to the placebo group. Those on a higher Dupixent dose experienced marked improvements in disease severity, as measured by endoscopic evaluations, with these benefits lasting up to a year. Patients on a lower dose saw improvements that were either on par with or less than those on the higher dose.

Moreover, Dupixent contributed to an increase in body weight for age percentile by week 16, an effect that persisted for a year. The safety profile for children in this trial was generally consistent with the established safety data for adolescents and adults treated with Dupixent for EoE.

Principal investigator Mirna Chehade from the Icahn School of Medicine at Mount Sinai commented that the findings "reinforce the positive results seen in older patients with EoE and strengthen our understanding of IL4 and IL13 as key drivers of the type 2 inflammation underlying this disease."

In January, the US Food and Drug Administration approved Dupixent for treating EoE in pediatric patients aged one to 11 years who weigh at least 15 kilograms. Currently, the European Medicines Agency is also reviewing the therapy for use in this age group.

Beyond its application for EoE, Dupixent has received approvals for treating various conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.