Long-Term Effectiveness of Dupilumab in Eosinophilic Esophagitis: Results From the DUPEOETALY Study

Background & Aims Dupilumab, a monoclonal antibody targeting the interleukin-4 receptor alpha, is increasingly used for eosinophilic esophagitis (EoE) treatment. The DUPEOETALY study evaluates its long-term effectiveness in an Italian cohort over 72 weeks. Methods This retrospective observational study included patients with EoE from 50 Italian centers, unresponsive or intolerant to conventional therapies. Participants received dupilumab through compassionate use or off-label programs before its regulatory approval. Dysphagia Symptom Questionnaire (DSQ), EoE Endoscopic Reference Score (EREFS), and eosinophil count per high-power field (Eos/HPF) were assessed at baseline, 12, 24, 36, 48, 60, and 72 weeks. Changes in outcomes over time were analyzed using mixed-effects regression models. Results The cohort included 167 patients (median age, 21.5 years; interquartile range [IQR], 15–32.75 years; median diagnosis age, 17 years; IQR, 11.3–29 years; 77.8% male). At baseline, 76% had a personal history of atopy, 86.2% had used corticosteroids, and 94% had used proton pump inhibitors. Median body mass index was 21.63 kg/m 2 (IQR, 19.71–24.44 kg/m 2 ). All primary outcomes improved significantly over time. DSQ score decreased from 22.14 ± 26.63 to 0.21 ± 2.30, EREFS from 4.95 ± 3.43 to 0.07 ± 0.09, and Eos/HPF from 36.80 ± 31.75 to 0.06 ± 0.46. Improvements increased with treatment duration. By week 72, 98.3% of patients achieved remission criteria (DSQ ≤5, Eos/HPF ≤15, and EREFS ≤2). Mixed-effects models confirmed results were independent of baseline demographics and prior therapies. Adverse events were minimal, dropping from 3.8% (week 12) to 0% (week 60). Conclusions The DUPEOETALY study confirms dupilumab's effectiveness in reducing symptomatic, endoscopic, and histological EoE markers. Longer treatment improves outcomes, and its safety profile supports dupilumab as a viable option for long-term management of EoE.