S893 Design of the Phase 4, Prospective, Observational, Multicenter EDESIA Registry Assessing Long-Term Outcomes in Patients With Eosinophilic Esophagitis Initiating Dupilumab in Routine Clinical Practice

Introduction: Eosinophilic esophagitis (EoE) is a chronic, progressive, type 2 inflammatory disease that significantly impacts patients’ quality of life. Dupilumab, a fully human monoclonal antibody that blocks the signaling of interleukin (IL)-4 and IL-13, key and central drivers of type 2 inflammation, has been approved in the U.S. and the E.U. for the treatment of EoE in patients aged ≥1 year and weighing ≥15 kg, based on the results of randomized controlled trials. However, data on the use of dupilumab for EoE in real-world clinical practice are limited. Here we present the design of the phase 4, prospective, observational, multicenter Eosinophilic Esophagitis Adolescent and Adult Patients Treated With DUPIXENT® As Standard of Care (EDESIA) registry (NCT06693531) that aims to investigate the effect of dupilumab use for EoE in routine clinical practice in the U.S. Methods: Patients with EoE aged ≥12 years at baseline assessment who initiate treatment with dupilumab according to FDA-approved prescribing information will be eligible for enrollment. Eligible patients must be willing and able to comply with the required registry procedures and assessments, be able to understand and complete registry-related questionnaires, and provide written, informed consent. Exclusion criteria include a contraindication to dupilumab per the prescribing information; treatment with dupilumab within 6 months prior to the screening assessment; any condition that, in the opinion of the investigator, may interfere with the patient’s ability to participate in the registry; or participation in an ongoing interventional study within 6 months of the baseline assessment. Patients will be assessed at baseline (the time of first treatment with dupilumab), at months and 6, and then every 6 months through month 36. Target enrollment is 300 patients. Results: The study will assess baseline demographic and disease characteristics as well as longitudinal treatment patterns (including concomitant medications and elimination diets for EoE) and generate longer-term real-world safety and effectiveness data in patients with EoE initiating dupilumab treatment in clinical practice. The length of inclusion in the registry is 36 months although interim analyses will be conducted. Conclusion: The results of the phase 4 prospective EDESIA registry will expand on previous clinical trial data and add to the understanding of the real-world use of dupilumab for the treatment of EoE in patients aged ≥12 years.