Monday, July 15, 2024

Eosinophilic Esophagitis Phase 3 Trial Shows Positive Results for Dupixent in Children

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Eosinophilic esophagitis (EoE) was the focus of a Phase 3 trial for Dupixent® (dupilumab), with Regeneron Pharmaceuticals, Inc. and Sanofi announcing the publication of positive results in the New England Journal of Medicine (NEJM). The study focused on children aged 1 to 11 years with eosinophilic esophagitis. The findings revealed that a significant proportion of children receiving weight-tiered higher doses of Dupixent experienced marked improvements in key disease measures compared to those on placebo at week 16.

This data underpinned the U.S. Food and Drug Administration (FDA) Priority Review and subsequent approval of Dupixent for children aged 1 to 11 years weighing at least 15 kg. Additionally, the European Medicines Agency is currently reviewing the regulatory submission for this age group.

Eosinophilic esophagitis is a chronic and progressive disease characterized by type 2 inflammation, which damages the esophagus and impairs its function. Diagnosing EoE is challenging as its symptoms can be mistaken for other conditions, leading to delays in diagnosis. EoE severely impacts a child’s ability to eat, causing symptoms such as abdominal pain, trouble swallowing, heartburn, vomiting, and failure to thrive. Continuous management of EoE is essential to mitigate the risk of complications and disease progression.

The Phase 3 trial data demonstrated that children receiving either weight-tiered higher or lower doses of Dupixent achieved histologic remission at week 16, compared to those on placebo. Specifically, the higher dose group showed significant improvements in disease severity, as assessed by endoscopic measures, with sustained results for up to one year. The lower dose group also saw improvements, though these were either comparable or slightly lower than those in the higher dose group. Additionally, Dupixent led to numerical improvements in body weight for the age percentile by week 16, which were sustained at one year. These improvements were evaluated as exploratory and secondary endpoints in Parts A and B of the trial, respectively.

Eosinophilic Esophagitis Study Confirms Consistent Safety Profile and Efficacy of Dupixent

The safety profile of Dupixent in this trial was consistent with its known safety profile in adolescents and adults with EoE. Common adverse events (≥10%) in either weight-based dosing regimen versus placebo included COVID-19, nausea, injection site pain, and headache during Part A of the trial. The long-term safety profile in children aged 1 to 11 years during Part B was similar to that observed during Part A, with one case of helminth infection reported with Dupixent.

Dr. Mirna Chehade, principal investigator of the trial and a specialist at the Mount Sinai Center for Eosinophilic Disorders, emphasized the significance of these findings. “The NEJM publication of these Phase 3 dupilumab results is a testament to the importance of these data and the potential for dupilumab to change the standard of care for many young children with eosinophilic esophagitis.

These children commonly experience feeding difficulties, food refusal, and failure to thrive during a critical time of their growth and development. These data showed that weight-tiered higher dose dupilumab significantly improved key eosinophilic esophagitis histologic, endoscopic, and cellular measures in children as young as 1-year-old with sustained results for up to one year. These results reinforce the positive results seen in older patients with eosinophilic esophagitis and strengthen our understanding of IL-4 and IL-13 as key drivers of the type 2 inflammation underlying this disease.”

Eosinophilic Esophagitis

Dupixent Approved for Eosinophilic Esophagitis in Young Children Following Positive Phase 3 Results

For U.S. patients with EoE weighing at least 15 kg, the FDA-approved dosage for Dupixent is 200 mg or 300 mg every other week, or 300 mg weekly, based on weight. The study’s findings not only support the effectiveness of Dupixent in treating EoE but also highlight its potential to become a standard treatment for this challenging condition in young children.

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Dr. Mirna Chehade has served as a paid consultant for Regeneron and Sanofi and has received research grant funding from Regeneron. The collaboration between these pharmaceutical companies and medical researchers continues to pave the way for innovative treatments that address unmet medical needs.

The publication of the Phase 3 trial results for Dupixent in the NEJM marks a significant advancement in the treatment of eosinophilic esophagitis in young children. With the majority of patients achieving histologic remission and experiencing sustained improvements, Dupixent stands out as a promising therapy for managing this chronic and debilitating condition. As the medical community continues to explore and understand the drivers of type 2 inflammation, therapies like Dupixent offer hope for improved patient outcomes and enhanced quality of life for children suffering from EoE.

 

Resource: Regeneron Pharmaceuticals, June 26, 2024

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