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Around 25% of patients with ulcerative colitis will develop acute severe colitis during the course of their disease. The first-line treatment for acute severe colitis is intravenous corticosteroid therapy. In case of a cortico-resistant form, treatment with intravenous (ciclosporin or Infliximab is indicated), according to European guidelines.
The emergence of biosimilar in the last years is a turning point in a context of optimizing healthcare costs and improving patient quality of life, with the arrival of the subcutaneous form of Infliximab in 2020, with similar results in terms of clinical remission, but also blood levels of Infliximab compared with the intravenous form. To our knowledge, there are very few data on the use of subcutaneous Infliximab after intravenous induction in patients with acute severe colitis.
The aim of this study is to evaluate the efficacy of subcutaneous Infliximab in ulcerative colitis patients with acute severe colitis, and the factors associated with treatment failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Global cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Data collection from medical records |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment failure at 12 months to describe treatment effectiveness | Absence of steroid free clinical remission (Mayo score ≤2, with every sub-score ≤1) or absence of endoscopic response (Mayo endoscopic sub-score ≤1) or use of a rescue treatment if relapse (other than Infliximab) or occurrence of a severe adverse event with withdrawal of treatment or colectomy or death during follow-up | After study completion, average of 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in acute severe ulcerative colitis treated with subcutaneous Infliximab
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bénédicte CARON, MD, PhD | Contact | +33383155580 | b.caron@chru-nancy.fr |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |