Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis: a Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness
研究概览
简要总结
Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Janus kinase inhibitors (JAKi) have attracted considerable attention as potential candidates for treating hospitalised patients with severe UC and are increasingly used in this setting. For tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. There are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis.
The aim of this study is to develop a large retrospective cohort of JAKi-treated hospitalised UC patients to describe the safety and effectiveness of using JAKi in this setting.
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,
- •Established diagnosis of ulcerative colitis as per ECCO (European Crohn´s and Colitis Organisation) criteria,
- •Hospitalisation at any point for treatment of ulcerative colitis disease relapse,
- •Receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the treatment of severe UC during inpatient stay,
- •Endoscopically confirmed active disease (Mayo endoscopic subscore ≥ 2) within previous four weeks,
- •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
- •Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease,
- •Receiving JAKi prior to admission,
- •Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified on admission.
结局指标
主要结局
Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness
时间窗: after study completion, average of 1 month
* Absence of steroid-free clinical remission according to the PRO-2 (stool ≤1 and rectal bleeding sub-score of 0) * Use of a prohibited treatment for relapse (partial Mayo score \>5) * Severe adverse event leading to discontinuation of JAKi treatment * Colectomy * Death during the study period
次要结局
未报告次要终点
研究者
Dr Laurent PEYRIN-BIROULET
Principal Investigator / Scientific responsible
Central Hospital, Nancy, France