Long-term Outcome of TNF Alpha Therapy in IBD

Study Overview
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Brief Summary
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The aim of this retrospective study is to assess the outcome of patients with inflammatory bowel disease (IBD) under TNF-alpha antibody therapy over a period of 20 years

Detailed Description
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Long-term results published so far show that over the years a large part of patients have to stop TNF Alpha antibody therapy in IBD. Reasons are mostly loss of effectiveness or intolerance or side effects. Reasons for the termination are usually poorly characterized with regard to the exact reason and time. As a consequence, the aim of this retrospective study is to assess the outcome of patients with inflammatory bowel disease under TNF-alpha antibody therapy over a period of 20 years

Official Title
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Long-term Outcome of TNF Alpha Therapy in IBD

Conditions
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IBD

Intervention / Treatment
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* Other: TNF Alpha therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a confirmed IBD diagnosis TNF Alpha antibody therapy in the last 20 years at our outpatient clinic Exclusion Criteria: Not Meeting the inclusion criteria Lack of clinical data, no follow up available
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ulcerative Colitis (UC)<br>This Group includes all patients suffering from UC who have been treated with a TNF Alpha antibody within the last 20 years at the IBD outpatient clinic at our Hospital. | Other: TNF Alpha therapy<br>* Retrospective analysis of outcome of first TNF Alpha therapy<br>|
| Crohn's disease (CD)<br>This Group includes all patients suffering from CD who have been treated with a TNF Alpha antibody within the last 20 years at the IBD outpatient clinic at our Hospital. | Other: TNF Alpha therapy<br>* Retrospective analysis of outcome of first TNF Alpha therapy<br>|
| IBD unclassified<br>This Group includes all patients suffering from IBD unclassified who have been treated with a TNF Alpha antibody within the last 20 years at the IBD outpatient clinic at our Hospital. | Other: TNF Alpha therapy<br>* Retrospective analysis of outcome of first TNF Alpha therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of first TNF Alpha Therapy in IBD patients | The main endpoint of this retrospective Analysis is the length of Treatment with the first TNF Alpha therapy in IBD | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of further biologicals after first TNF Alpha therapy | Follow-up drug therapy after termination of TNF Alpha therapy | 20 years | 
| Rate of surgical interventions after first TNF Alpha | Resections after the termination of first TNF Alpha therapy | 20 years | 
| Reasons for discontinuing therapy | Loss of response, side effects etc. | 20 years | 
| Predictive factors | Predictive factors for long-term response (BMI, CRP, Alb etc.) | 20 years | 
| Number of side effects | Side effects of the primarily used TNF-alpha antibodies leading to discontinuation of the drug | 20 years |