Sanofi Announces Dupixent (dupilumab) Shows Significant Disease Improvements in Phase 3 Trial for Eosinophilic Esophagitis

Sanofi www.sanofi.com announced results from a phase 3 trial assessing Dupixent (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE).  The trial met its co-primary endpoints in patients taking Dupixent 300 mg weekly, showing significant improvements in clinical (Dysphagia Symptom Questionnaire) and histologic disease measures compared to placebo. Data from the clinical trial program will be submitted to regulatory authorities by 2022.

In this trial, 80 patients were enrolled into a Dupixent 300 mg weekly treatment group and 79 patients were enrolled into a placebo group. The co-primary endpoints at 24 weeks assessed patient-reported measures of difficulty swallowing (change from baseline in the Dysphagia Symptom Questionnaire, or DSQ), and esophageal inflammation (proportion of patients achieving peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf).

When compared to placebo, patients treated with Dupixent 300 mg weekly experienced the following changes by week 24: a 64% reduction in disease symptoms from baseline compared to 41% for placebo and a 23.78-point improvement on the 0-84 DSQ scale for Dupixent treatment compared to a 13.86 poin...

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