Phase III trial of Dupixent for eosinophilic esophagitis published in New England Journal of Medicine
The New England Journal of Medicine has published results from a positive Phase III trial showing adults and adolescents treated with Dupixent (dupilumab), from Sanofi, 300 mg weekly experienced significant improvements in signs and symptoms of eosinophilic esophagitis (EoE), which were sustained for up to one year
As published, patients received Dupixent 300 mg either weekly or every two weeks in the Phase III trial. Patients receiving Dupixent weekly experienced improvement in the ability to swallow and achieved histological disease remission. Additionally, these patients experienced improved anatomic, cellular, molecular and health-related quality of life measures, with improvements in signs and symptoms of EoE sustained for up to one year.
Patients treated with Dupixent every two weeks experienced histological disease remission but did not experience improvement in the ability to swallow. The current FDA-approved dosage for Dupixent as a treatment for children and adults aged 12 years and older with EoE, weighing at least 40 kg, is 300 mg weekly. The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events (at least 5%) that were more commonly observed with Dupixent included injection site reactions, nasopharyngitis and rash.
See: "Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis." Evan S. Dellon et al. N Engl J Med 2022; December 22, 2022 387:2317-2330 DOI: 10.1056/NEJMoa2205982
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