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/m2 (IQR, 19.71-24.44 kg/m2). 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.