EoE Module 10 References-Dellon et al N Engl J Med 2022 Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis

Dellon et al N Engl J Med 2022 Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis

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A study published in the New England Journal of Medicine reports on a three-part, phase 3 clinical trial evaluating the efficacy and safety of dupilumab, a monoclonal antibody, in treating eosinophilic esophagitis—a chronic inflammatory condition impacting the esophagus. Dupilumab blocks interleukin-4 and interleukin-13 signaling pathways, crucial in the disease's pathogenesis.<br /><br />In the double-blind study, patients aged 12 and older were randomized to receive weekly or bi-weekly doses of 300 mg of dupilumab or placebo for 24 weeks. Following this, eligible participants continued for an additional 28 weeks. The primary evaluations at week 24 included histologic remission—defined as a reduction in esophageal eosinophils to no more than 6 per high-power field—and improvements in the Dysphagia Symptom Questionnaire (DSQ) score, measuring the frequency and severity of swallowing difficulties.<br /><br />Results demonstrated that 60% of patients on weekly dupilumab achieved histologic remission compared to 5% on placebo. Additionally, significant improvements were observed in DSQ scores for the weekly dupilumab group versus the placebo. However, the bi-weekly dupilumab did not show significant symptom improvement compared to placebo.<br /><br />Serious adverse events were relatively few and mostly comparable between dupilumab and placebo groups, with injection-site reactions being the most common adverse effect. The trial indicated that weekly dupilumab treatment improved both histological markers and disease symptoms in adolescents and adults with eosinophilic esophagitis, supporting its potential as an effective therapeutic option. The trial was funded by Sanofi and Regeneron Pharmaceuticals. However, ongoing monitoring and additional research may be necessary to confirm long-term benefits and safety.

Keywords

dupilumab

eosinophilic esophagitis

clinical trial

monoclonal antibody

interleukin-4

interleukin-13

histologic remission

Dysphagia Symptom Questionnaire

adverse events

Sanofi Regeneron