P0660 - 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

Evan S. Dellon, MD, MPH¹, Sandy R. Durrani, MD², Sabina deMarchi, PharmD², Mirna Chehade, MD, MPH³, Emily McGowan, MD, PhD⁴, James T. Angello, PharmD⁵, Amr Radwan, MBBCh, MA²
1Center for Esophageal Diseases and Swallowing, University of North Carolina School of Medicine, Chapel Hill, NC; 2Regeneron Pharmaceuticals Inc., Tarrytown, NY; 3Mount Sinai Center for Eosinophilic Disorders, Icahn School of Medicine at Mount Sinai, New York, NY; 4Division of Allergy and Immunology, University of Virginia, Charlottesville, VA; 5Sanofi, Morristown, NJ

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 USA and the EU 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 EDESIA registry (NCT06693531) that aims to investigate the effect of dupilumab use for EoE in routine clinical practice in the USA.

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 3 and 6, and then every 6 months through Month 36. Target enrollment is 300 patients (Figure).

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.

Discussion: 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.


Figure: Figure. EDESIA (Evaluation of Dupilumab for Eosinophilic Esophagitis: Registry Study in Adults and Adolescents) study design.
† Screening and baseline assessments may be combined, provided all required procedures and assessments are completed before initiating dupilumab treatment.
D, Day; EoE, eosinophilic esophagitis; M, Month.

Disclosures:
Evan Dellon: AbbVie – Consultant. Adare/Ellodi – Consultant, Grant/Research Support. Akesobio – Consultant. Alfasigma – Consultant. ALK – Consultant. Allakos – Consultant, Grant/Research Support. Amgen – Consultant. Apogee – Consultant. Apollo – Consultant. Aqilion – Consultant, Grant/Research Support. Arena/Pfizer – Consultant, Grant/Research Support. Aslan – Consultant. AstraZeneca – Consultant, Grant/Research Support. Avir – Consultant. Biocryst – Consultant. Bryn – Consultant. Calypso – Consultant. Celgene/Receptos/Bristol Myers Squibb – Consultant, Grant/Research Support. Celldex – Consultant, Grant/Research Support. Dr. Falk Pharma – Consultant. EsoCap – Consultant. Eupraxia – Consultant, Grant/Research Support. Ferring – Consultant, Grant/Research Support. GI Reviewers – Consultant. GSK – Consultant, Grant/Research Support. Holoclara – Consultant, Grant/Research Support. Invea – Consultant, Grant/Research Support. Knightpoint – Consultant. LucidDx – Consultant. Meritage – Grant/Research Support. Miraca – Grant/Research Support. Morphic – Consultant. Nexstone Immunology/Uniquity – Consultant. Nutricia – Consultant, Grant/Research Support. Parexel/Calyx – Consultant. Phathom – Consultant. Regeneron Pharmaceuticals Inc. – Consultant, Grant/Research Support. Revolo – Consultant, Grant/Research Support. Robarts/Alimentiv – Consultant. Sanofi – Consultant, Grant/Research Support. Shire/Takeda – Consultant, Grant/Research Support. Target RWE – Consultant. Third Harmonic Bio – Consultant. Uniquity – Grant/Research Support. Upstream Bio – Consultant.
Sandy Durrani: Regeneron Pharmaceuticals Inc – Employee, Stock-publicly held company(excluding mutual/index funds).
Sabina deMarchi: Regeneron Pharmaceuticals Inc. – Employee, Stock-publicly held company(excluding mutual/index funds).
Mirna Chehade: Adare Pharma Solutions/Ellodi Pharmaceuticals – Consultant, Grant/Research Support. Allakos – Consultant, Grant/Research Support. AstraZeneca – Consultant, Grant/Research Support. Bristol Myers Squibb – Consultant. Celgene – Grant/Research Support. Danone – Grant/Research Support. Nexstone Immunology/Uniquity Bio – Consultant. Phathom Pharmaceuticals – Consultant. Recludix Pharma – Consultant. Regeneron Pharmaceuticals Inc. – Consultant, Grant/Research Support. Sanofi – Consultant. Shire/Takeda – Consultant, Grant/Research Support.
Emily McGowan: AstraZeneca – Advisory Committee/Board Member, Consultant. Bristol Myers Squibb – Advisory Committee/Board Member, Consultant. Regeneron Pharmaceuticals Inc./Sanofi – Advisory Committee/Board Member, Consultant. Takeda Pharmaceuticals – Advisory Committee/Board Member, Consultant.
James Angello: Sanofi – Employee, Stock Options.
Amr Radwan: Regeneron Pharmaceuticals Inc. – Employee, Stock-publicly held company(excluding mutual/index funds).

Evan S. Dellon, MD, MPH¹, Sandy R. Durrani, MD², Sabina deMarchi, PharmD², Mirna Chehade, MD, MPH³, Emily McGowan, MD, PhD⁴, James T. Angello, PharmD⁵, Amr Radwan, MBBCh, MA². P0660 - 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, ACG 2025 Annual Scientific Meeting Abstracts. Phoenix, AZ: American College of Gastroenterology.