Weekly dupilumab demonstrated significant and clinically meaningful improvements in histologic, symptomatic, endoscopic, and molecular aspects of eosinophilic esophagitis (EoE). In addition, dupilumab was well tolerated. That was found in part A of an ongoing 3-part, randomized, placebo-controlled, phase 3 study1.
EoE is a chronic type 2 inflammatory disease of the esophagus that can substantially impair the quality of life. Only a few treatment options are currently available and the response to the current therapy is generally suboptimal.
Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13. These cytokines are key drivers of type 2 inflammation in EoE. In a previous phase 2 proof-of-concept study, dupilumab significantly improved histological and clinical outcomes of EoE with an acceptable safety profile. In the current, ongoing, phase 3 trial, the efficacy and safety of weekly dupilumab 300 mg are compared with placebo in 81 adult and adolescent patients with EoE with a treatment duration of 24 weeks.
The first primary endpoint was the proportion of patients achieving a peak esophageal intraepithelial eosinophil count of ≤6 eosinophils per high-power field. At week 24, a significantly higher proportion of patients treated with dupilumab versus placebo achieved:
Furthermore, dupilumab-treated versus placebo-treated patients had a significantly greater percent change from baseline in:
Dupilumab was generally well tolerated with an acceptable safety profile. The most common treatment-emergent adverse events for dupilumab versus placebo were injection-site reactions (16.7% vs 10.3%) and nasopharyngitis (11.9% vs 10.3%).
1. Dellon ES. Dupilumab efficacy and safety in adult and adolescent patients with eosinophilic esophagitis: results from part A of a randomized, placebo-controlled three-part, phase 3 study. UEG Week E-congress 2020, abstract LB22.