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

Sanofi150 enrolled

Overview

This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior EoE treatments. Furthermore, this NIS aims to describe the long-term effectiveness of dupilumab for the treatment of EoE as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (HRQoL) during an individual observational period of two years. In addition, data on real-world use patterns and long-term safety data of dupilumab treatment for EoE will be collected.

The study duration for each participant is planned to be 2 years. Total study duration is approximately 4 years.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Eosinophilic Esophagitis

Interventions

DupilumabDRUG

This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy * Patients for whom the treating physician has decided to initiate new treatment with dupilumab for EoE according to EU-SmPC independently from entry in study or for whom treatment with dupilumab for EoE according to EU-SmPC has been started within the last 7 days. The decision to initiate dupilumab treatment is made by the treating physician and the patient according to the patients' medical need and to the standard of best medical practice. This decision is made independently and before inclusion in this NIS. * ≥ 12 years of age at baseline visit * ≥ 40 kg bodyweight * Voluntary study participation and signed written informed consent by patient and parent(s)/guardian(s), if applicable Exclusion Criteria: * Patients who have a contraindication to dupilumab according to the current EU-SmPC. * Patients who have been treated with dupilumab for more than 7 days * Any acute or chronic condition that, in the treating physician's opinion, would limit the patients' ability to complete questionnaires or to participate in this study or impact the interpretation of the results. * Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study (parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (15)

Investigational Site Number: 0000009

Aschaffenburg, Bavaria, Germany

RECRUITING

Investigational Site Number: 0000014

Augsburg, Bavaria, Germany

RECRUITING

Investigational Site Number: 0000001

Dachau, Bavaria, Germany

RECRUITING

Investigational Site Number: 0000012

Erlangen, Bavaria, Germany

RECRUITING

Investigational Site Number: 0000005

Giessen, Hesse, Germany

RECRUITING

Investigational Site Number: 0000011

Wetzlar, Hesse, Germany

RECRUITING

Investigational Site Number: 0000013

Osnabrück, Lower Saxony, Germany

RECRUITING

Investigational Site Number: 0000002

Weyhe-Kirchweyhe, Lower Saxony, Germany

RECRUITING

Investigational Site Number: 0000007

Bochum, North Rhine-Westphalia, Germany

RECRUITING

Investigational Site Number: 0000003

Burbach, North Rhine-Westphalia, Germany

RECRUITING

...and 5 more locations

Outcomes

Primary Outcomes

Descriptive statistical analysis of medical history characteristics

Time frame: At baseline

Descriptive statistical analysis of socio-demographic characteristics

Time frame: At baseline

Descriptive statistical analysis of disease characteristics

Time frame: At baseline

Secondary Outcomes

Absolut change from baseline in endoscopic reference score (EREFS)

Absolut change from baseline in EREFS (including inflammatory and fibrostenotic subscore)

Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment

Proportion of patients with eosinophils per high power field (EOS/hpf) < 15 in esophageal biopsies

Time frame: After 3, 6 (optional), 12 and 24 months of dupilumab treatment

Change in clinical symptoms from baseline

Change in clinical symptoms (as assessed in clinical practice) from baseline

Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

Behavioral changes regarding food intake from baseline

Behavioral changes regarding food intake (as reported by the patient)

Time frame: From baseline until 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

Absolute change from baseline in Dysphagia Numerical Rating Scale (NRS)

Scale from 0 (no trouble to swallow) - 10 (maximum trouble to swallow)

Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

Absolute change from baseline in Hospital Anxiety and Depression Scale (HADS)

Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

Absolute change from baseline Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS v2.0)

Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

Absolute change from baseline Pediatric Quality of Life Inventory (PEDS-QL)

Time frame: After 1, 3, 6, 9, 12, 18 and 24 months of dupilumab treatment

Number of hospitalizations due to EoE

Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment

Number of sick leave days at work due to EoE

Time frame: During the last 12 months before baseline and after 12 and 24 months of dupilumab treatment

Reason(s) for initiation of dupilumab treatment

Time frame: At baseline

Descriptive statistical analysis of details on dupilumab treatment

Descriptive analysis: form of administration, location of administration

Time frame: Throughout the study, for approximately 24 months after dupilumab treatment

Analysis of treatment emergent adverse events (TEAEs)

Quantity of treatment emergent adverse events, quantity of TEAE that lead to ending of therapy, collection of type of TEAE

Time frame: Throughout the study, for approximately 24 months after initiation of dupilumab treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (15)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts