Comparison of Short and Long-term Efficacy Between Infliximab and Adalimumab on Patients With Ulcerative Colitis - a Retrospective Observational Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Percentage of patients achieving steroid-free clinical remission
研究概览
简要总结
Anti-TNF (tumor necrosing factor) treatment with infliximab (IFX) and adalimumab (ADA) are established first-line biological therapies used in treatment of patients with ulcerative colitis (UC). There are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that IFX might be more effective than ADA for the induction of clinical remission. However, several observational studies conclude that ADA seem to have similar effect as IFX in treating patients with UC but these studies have limitations.
The overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (IFX) and adalimumab (ADA) in treating bio-naive patients with UC in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-TNF treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-100 years.
- •Diagnosis of ulcerative colitis confirmed by endoscopy and histology.
- •Mild, moderate and severe disease activity.
- •Initiation of IFX or ADA-treatment at one of the centers of the study.
排除标准
- •Clinical remission.
- •Previous colonic surgery (resection of colonic segment or colectomy).
- •Primary indication for anti-TNF therapy by other disease than UC.
- •Prior use of any anti-TNF or other biologic or small molecule therapy.
- •Rescue therapy (i.e. infliximab used on hospitalized patients receiving intravenous corticosteroids).
研究组 & 干预措施
Infliximab
Bio-naive patients with ulcerative colitis who starts treatment with infliximab
干预措施: Infliximab (Drug)
Adalimumab
Bio-naive patients with ulcerative colitis who starts treatment with adalimumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
Percentage of patients achieving steroid-free clinical remission
时间窗: One year after start of anti-TNF therapy
Partial Mayo score ≤2 with no subscore \>1 and no use of steroids between 6 and 12 months after start of anti-TNF therapy (Partial Mayoscore, range 0-9, with higher value indicating more severe disease activity).
次要结局
- Percentage of patients achieving biochemical remission(One year after start of anti-TNF therapy)
- Percentage of patients achieving clinical response(Three months after start of anti-TNF therapy)
- Percentage of patients achieving endoscopic response(3-12 months after start of anti-TNF therapy)
- Percentage of patients achieving clinical remission(One year after start of anti-TNF therapy)
- Percentage of patients achieving endoscopic remission(3-12 months after start of anti-TNF therapy)