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Phase III trial of Dupixent shows efficacy in eosinophilic esophagitis.

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Last updated:26th Oct 2021
Published:26th Oct 2021
Results from a second Phase III trial assessing the investigational use of Dupixent (dupilumab), from Sanofi/Regeneron Pharma, in patients 12 years and older with eosinophilic esophagitis (EoE) demonstrated that 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.

Patients treated with Dupixent 300 mg weekly experienced the following changes by week 24 compared to placebo: 64% reduction in disease symptoms from baseline compared to 41% for placebo (p=0.0008). Dupixent patients experienced a 23.78 point improvement on the 0-84 DSQ scale, compared to a 13.86 point improvement for placebo (p<0.0001); baseline dsq scores were approximately 38 and 36 points, respectively. Nearly 10 times as many dupixent patients achieved histological disease remission: 59% of patients achieved histological disease remission compared to 6% of placebo patients (p><0.0001). This was measured by the proportion of patients who achieved a peak esophageal intraepithelial eosinophil count of below 6 eos hpf; mean baseline peak levels were 89 and 84 eos hpf, respectively.></0.0001).></0.0001);>

In September 2020, the FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients 12 years and older with EoE. Results from the extended active treatment period (up to 52 weeks) of a previously reported Phase III trial studying Dupixent 300 mg weekly for 24 weeks were recently presented at the United European Gastroenterology Week Virtual 2021 congress. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. Data from the clinical trial program will be submitted to regulatory authorities by 2022.

Condition: Eosinophilic Oesophagitis
Type: drug

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