Efficacy of Subcutaneous Infliximab in Acute Severe Ulcerative Colitis: a Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Treatment failure at 12 months to describe treatment effectiveness
研究概览
简要总结
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.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years old
- •Diagnosis of acute severe ulcerative colitis according to Truelove Witts criteria
- •Patients treated with at least one injection of subcutaneous Infliximab after induction with two or three intravenous perfusions of Infliximab
- •Patients with a follow-up of at least 12 months after the first subcutaneous injection
- •12-month data available in medical records
- •Patient who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data.
排除标准
- •Patients with intravenous Infliximab as a maintenance treatment
- •Patients switched from intravenous to subcutaneous form during follow-up, and who received more than three intravenous perfusions
- •Protected persons.
结局指标
主要结局
Treatment failure at 12 months to describe treatment effectiveness
时间窗: After study completion, average of 1 month
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
次要结局
未报告次要终点
研究者
CARON Bénédicte
MD, PhD
Central Hospital, Nancy, France