Eosinophilic Gastrointestinal Disorders (EGIDs)
Conditions
Brief summary
This is a single-center observational study to investigate the efficacy and tolerability of dupilumab in children with refractory eosinophilic gastrointestinal disorders.
Detailed description
Eosinophilic Gastrointestinal Disorders (EGIDs) are chronic inflammatory diseases caused by extensive infiltration of eosinophils in the gastrointestinal tract. Treatment requires long-term dietary avoidance, long-term oral administration of high-dose omeprazole, as well as hormones and immunosuppressants, but the results are unsatisfactory and the side effects are significant. Dupilumab is a fully human monoclonal antibody (IgG4 type) that can specifically bind to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes to inhibit the signal transduction of IL-4 and IL-13. Current studies have shown that subcutaneous treatment with dupilumab for eosinophilic esophagitis has significant efficacy. In recent years, this drug has been reported to be used for various forms of gastrointestinal diseases such as eosinophilic gastritis, duodenitis, etc., with remarkable efficacy. In recent years, there has been an increasing number of children with refractory eosinophilic gastrointestinal diseases, which can easily cause repeated large ulcers, perforation, and stenosis in the gastrointestinal tract, requiring surgical intervention. This disease seriously affects the growth and development of children and urgently requires better treatment options. This study aims to evaluate the efficacy and tolerance of dupilumab in children with refractory eosinophilic gastrointestinal diseases.
Interventions
Dose: For patients with weight ≥ 15kg but \< 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but \< 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week.
DEVICEsubcutaneous injection
Dose: For patients with weight ≥ 15kg but \< 30kg, take 200mg each time, every two weeks; for those with weight ≤ 30kg but \< 60kg, take 300mg each time, every two weeks; for those with weight ≥ 60kg, take 300mg each time, once a week.
Sponsors
Children's Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Refractory Peptic Ulcers * with Refractory Eosinophilic Gastrointestinal Disorders
Exclusion criteria
* with Active Helicobacter pylori infection at present. * with Inflammatory bowel disease * with Parasite infection * with Cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic response rate | week12, week26, week52 | The ulcer reaches stage S (healed) or stage H (healing period), or the ulcer area has decreased by more than 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Change of Peak Eosinophil Counts in the Stomach | week12，week26，week52 | We will determine the relative change from baseline in the peak eosinophil count in the five high-power fields (HPFs) with the highest eosinophil density in the antrum and/or body of the stomach after intervention. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | within one year | The rate of the potential adverse events were monitored during the intervention. |
Countries
China
Contacts
Primary ContactYing Huang
Outcome results
None listed