1. Weekly dupilumab resulted in a significantly increased rate of histologic remission as compared to placebo in patients with eosinophilic esophagitis.
2. Weekly dupilumab also resulted in significantly reduced symptoms of dysphagia in comparison to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Eosinophilic esophagitis is a chronic immunologic allergic reaction thought to be triggered by exposure to a specific food or environmental allergens. Existing treatments have variable efficacy and do not always address the underlying inflammatory drivers of the condition. Dupilumab is a human monoclonal antibody that works on blocking specific proteins involved in propagating type 2 inflammatory processes involved in eosinophilic esophagitis. This study was a three-part phase 3 trial investigating the efficacy of dupilumab in treating eosinophilic esophagitis in comparison to a placebo. Patients were included who demonstrated poor response to at least eight weeks of treatment on an existing medication of proton-pump inhibitors. Results of the study found that weekly dupilumab was associated with significantly increased rates of histologic remission and decreased dysphagia symptoms as compared to placebo. However, there was no difference in comparison to placebo when dosed every two weeks. This study is limited by generalizability given the overrepresentation of White patients and a relatively short treatment period in comparison to the chronicity of this condition. This study offers insights into the potential utility of dupilumab in providing symptomatic relief and histologic improvement for persons with eosinophilic esophagitis.
Click here to read the study in NEJM
In-Depth [randomized controlled trial]: This study was a multiple-component, randomized, double-blind, placebo-controlled phase 3 clinical trial investigating the efficacy of dupilumab for treating eosinophilic esophagitis. Persons aged 12 or older with biopsy-confirmed eosinophilic esophagitis after eight weeks of proton-pump inhibitor use and a score of 10 or higher on the Dysphagia Symptoms Questionnaire (DSQ) were included. After applying selection criteria, 81 patients in Part A, 240 patients in Part B, and 37 patients in Part C were randomized in a 1:1 ratio to receive dupilumab or placebo. The primary outcomes of interest were histologic remission at 24 weeks and absolute change in DSQ score. Additional outcomes included eosinophils per high-power field, quality of life, endoscopy findings, use of rescue medications or procedures, and safety. Results of the primary analysis found that significantly more patients achieved histologic remission with dupilumab in comparison to placebo (p<0.001). Dupilumab was also associated with a significant improvement in DSQ scores in comparison to baseline in Part A and B (p<0.05). However, dosing every two weeks with dupilumab did not demonstrate significant improvement as compared to placebo. In terms of safety, the most common adverse event in the dupilumab group was an injection-site reaction. Serious adverse effects leading to discontinuation were reported in five patients receiving dupilumab and two patients receiving a placebo. The reasons for discontinuation were not reported. In summary, this study provided evidence that dupilumab may be superior to placebo in reducing dysphagia symptoms and inducing histologic remission when dosed weekly for patients with eosinophilic esophagitis.
Image: PD
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