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Phase 2 Study Results for Regeneron's(REGN) Dupilumab in Patients With Active Moderate-to-Severe Eosinophilic Esophagitis Released

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Clinical Data The primary endpoint of the study was the change from baseline to week 10 in the Straumann Dysphagia Instrument (SDI) score, a patient-reported measure of swallowing difficulty on a 0-9 point scale, with 9 indicating more severe symptoms. A total of 47 patients were randomized into two treatment groups in this 12-week treatment study, and both groups had a mean baseline SDI score of 6.4. Patients received either dupilumab 300 mg weekly following a 600 mg loading dose or placebo. At week 10, patients who received dupilumab 300 mg weekly reported a significant improvement in the ability to swallow with a three point reduction in their SDI score (45 percent improvement) compared to 1.3 points (19 percent improvement) for those patients who received placebo (p=0.0304). Secondary endpoints of the study included measures of the impact of dupilumab on endoscopic and histopathologic measures of disease severity, as well as symptoms. The results include: Š The mean change in the Eosinophilic Esophagitis Endoscopic Reference Score (EoE-EREFS) was significantly reduced by 1.9 points from baseline (48 percent improvement) in patients who received dupilumab weekly compared to 0.3 points (7 percent improvement) for those who received placebo at 12 weeks (p=0.0006). EoE-EREFS is a visual measure of disease severity (inflammation and fibrosis in the esophagus) on a 0-8 point scale, with 8 indicating more severe disease. The mean baseline score for the dupilumab group was 3.9 and for the placebo group was 4.3. Š The mean percent change in overall peak intraepithelial eosinophil count from baseline to 12 weeks was significantly reduced by 93 percent from baseline in patients who received dupilumab weekly compared to an increase of 14 percent in those who received placebo (p < 0.0001). Š The mean percent change in a composite measure of symptoms and quality of life, as measured by Eosinophilic Esophagitis Symptom Activity Index (EEsAI), was numerically improved (although not statistically significant) by 35 percent in patients who received dupilumab weekly compared to an 11 percent improvement for those who received placebo at 10 weeks (p=0.085). 
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Occurred on:
Oct 16, 2017
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Related Keywords Dupilumab, Eosinophilic Esophagitis