Prospective, Non-interventional Observational Study to Characterize Dupilumab in the Long-term Management of Eosinophilic Esophagitis, Safety and Patient Reported Outcomes in Clinical Routine

What this Trial Is About

Researchers are conducting a non-interventional, observational study to understand patients in Germany receiving dupilumab for eosinophilic esophagitis EoE. The study focuses on patients medical history, socio-demographic and disease characteristics, other related conditions, concurrent therapies, and prior EoE treatments. It also aims to evaluate the long-term effects of dupilumab on disease symptoms and patients quality of life over a two-year period. Participants in this study are those already prescribed dupilumab by their treating physicians in routine clinical practice no treatments are administered by the study itself. The study observes dupilumab use patterns, safety, and effectiveness during the two years of follow-up. Patients will be followed for approximately 24 months after starting dupilumab treatment with assessments at multiple timepoints to track changes in symptoms, biopsy results, and quality of life measures. During the study, participants will undergo evaluations including medical history review, clinical symptom assessment, endoscopic scoring, esophageal biopsies, and questionnaires on anxiety, depression, and quality of life. Researchers will also collect data on hospitalizations and sick leave related to EoE. Safety will be monitored throughout, and the total participation time for each person is about two years, within a four-year overall study timeline.

A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany