EoE Module 10 References-Hirano et al Gastroenterology 2020 Efficacy of dupiluman in a phase 2 RT of adults with activie EoE

Hirano et al Gastroenterology 2020 Efficacy of dupiluman in a phase 2 RT of adults with activie EoE

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The study assesses the efficacy and safety of Dupilumab, a monoclonal antibody, in treating adults with active eosinophilic esophagitis (EoE), a chronic inflammatory esophageal condition currently without FDA-approved pharmacologic treatments in the U.S. A Phase 2 randomized, double-blind, placebo-controlled trial was conducted from 2015 to 2017 across 14 sites in the U.S. It included 47 adult patients who had significant symptoms, defined as at least two episodes of dysphagia per week and a high level of eosinophilic infiltration in the esophagus.<br /><br />Patients were randomly assigned to receive weekly subcutaneous injections of either Dupilumab (300 mg) or placebo for 12 weeks. The primary endpoint was the change from baseline in the Straumann Dysphagia Instrument (SDI) score, measured as a symptom of EoE. Secondary endpoints included evaluations of histological and endoscopic features, esophageal distensibility, and safety.<br /><br />Results showed significant improvement with Dupilumab in reducing dysphagia (SDI PRO score reduction), esophageal eosinophilic infiltration, EoE histologic severity scores, and endoscopic visual changes compared to placebo. Dupilumab also increased esophageal distensibility significantly. However, it was associated with some adverse effects, including injection-site reactions and nasopharyngitis.<br /><br />Despite the trial being relatively short and involving a small number of participants, the results indicate that Dupilumab is effective in improving both symptoms and histological markers of EoE, making it a potential new treatment pathway for this condition. Further studies are needed to evaluate the long-term effectiveness and safety of Dupilumab in EoE treatment. The trial's registration number on ClinicalTrials.gov is NCT02379052.

Keywords

Dupilumab

eosinophilic esophagitis

monoclonal antibody

Phase 2 trial

dysphagia

Straumann Dysphagia Instrument

esophageal distensibility

histological features

endoscopic changes

adverse effects