托法西提尼布在对免疫调节剂的中度至重度性结肠炎的类固醇依赖患者中的真实世界经验
Rajendra Bhati1,2, Abhishek Yadav2, Bobby Mitrolia2
1Gastroenterology and Hepatology, All India Institute of Medical Sciences, Jodhpur, Jodhpur, IND.
Cureus
|March 25, 2025
概括
托法西替尼在接受免疫调节剂治疗的患者中有效治疗类固醇依赖性性结肠炎 (UC),显示出显著的临床和内镜缓解率. 这种口服治疗为中度至重度UC提供了一个安全的替代方案,观察到的不良事件最小.
科学领域:
- 胃肠病学 胃肠病学
- 药理学 药理学是指药理学的学科.
- 免疫学 免疫学 免疫学
背景情况:
- 中度至重度的性结肠炎 (UC) 给使用免疫调节剂的类固醇依赖患者带来了挑战.
- 生物药物是主要的选择,如果不有效,则认为手术是无效的.
- 托法西提尼布是一种口服的Janus激酶抑制剂,通常是生物失败后的二线治疗.
研究的目的:
- 评估托法西提尼布在生物上天真,依赖类固醇的UC患者的疗效和安全性.
- 评估tofacitinib在印度患者队列中的有效性.
- 在这个特定的UC群体中提供印度关于托法西提尼布使用的数据.
主要方法:
- 一个开放的标签,单臂,前性观察性研究.
- 从2021年1月到2023年6月进行.
- 包括使用免疫调节剂的类固醇依赖性UC患者,在8周和24周评估结果.
主要成果:
- 在8周后,67.92%的患者表现出临床反应,35.8%的患者实现了临床缓解,22.64%的患者实现了内镜缓解.
- 在24周时,66.03%的患者获得了临床缓解 (p<0.001),41.50%的患者获得了内镜缓解 (p=0.003).
- 两名患者出现了疹,保守地管理;没有发生血栓栓塞事件.
结论:
- 口服托法西替尼在适度至严重的,依赖于类固醇的UC患者的免疫调节剂中显示出有效性.
- 治疗是安全的,具有有利的不良事件概况.
- 托法西提尼布对这一具有挑战性的患者群体来说是一个可行的治疗选择.
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