托法替尼治疗可用于安全有效治疗中重度活动期溃疡性结肠炎
- ①纳入334例接受托法替尼治疗的中重度活动期溃疡性结肠炎患者，随访375人年；
- ②第12周、24周、52周时，分别有35.3%、36.0%、35.2%的患者实现临床缓解，分别有18.5%、23.0%、25.7%的患者实现内镜缓解；
- ③44.5%的有初始反应的患者在降低至维持剂量（5mg BID）后失去应答，部分患者重新增加剂量（10mg BID），54.9%恢复应答；
- ④基线内镜评分较高和既往生物学失败的患者减少剂量后失去应答的风险更高；
- ⑤29%的患者发生不良事件，无严重不良事件。
主编推荐语
托法替尼（tofacitinib）是一种有效的口服小分子JAK抑制剂，被用于治疗溃疡性结肠炎（UC）。American Journal of Gastroenterology近日发表了加拿大多中心队列研究REMIT-UC的结果，报道了托法替尼治疗中重度活动期溃疡性结肠炎在现实世界中的有效性和安全性。本研究发现托法替尼通常是安全的，确认了近一半患者在降低剂量后对托法替尼失去应答，且仅部分患者增加剂量后恢复，为优化UC患者的JAK抑制剂治疗决策提供了可供参考的信息。
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延伸阅读本研究的原文信息和链接出处，以及相关解读和评论文章。欢迎读者朋友们推荐！
REMIT-UC: Real World Effectiveness and Safety of Tofacitinib for Moderate-to-Severely Active Ulcerative Colitis
托法替尼治疗中重度活动期溃疡性结肠炎的现实世界有效性和安全性
10.14309/ajg.0000000000002129
2022-12-08, Article
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Background: : We aimed to evaluate the real-world effectiveness and safety of tofacitinib for the treatment of ulcerative colitis (UC).
Methods:: REMIT-UC is a Canadian multicenter cohort study. Standardized data collection was performed on 334 consecutive adult UC outpatients treated with tofacitinib. The primary outcomes were achievement of clinical and endoscopic remission. Safety outcomes were reported using incidence rates (events/100 patient-years [PY] of exposure). A multivariable Cox proportional hazards model was used to evaluate predictors of loss of response after tofacitinib dose de-escalation to 5 mg twice daily (BID).
Results:: Clinical remission was achieved by 35.3% (106/300), 36.0% (104/289), and 35.2% (93/264) of patients at Weeks 12, 24, and 52, respectively. Endoscopic remission was achieved by 18.5% (15/81), 23.0% (28/122), and 25.7% (35/136) of patients at Weeks 12, 24, and 52, respectively. Incidence of serious infections, herpes zoster, and venous thromboembolism were 2.1 [0.9, 4.2], 0.5 [0.1, 1.9], and 1.1 [0.3, 2.7], respectively. Among responders, 44.5% (109/245) lost response during follow-up, which was recaptured in 54.9% (39/71) of patients who re-escalated to 10 mg BID. Patients with a baseline Mayo endoscopic score (MES) of 3 (aHR 3.60 [95% CI: 1.70-7.62]) and prior biologic failure (aHR 3.89 [95% CI: 1.28-11.86]) were at higher risk for losing response after dose reduction.
Conclusions: : One-third of UC patients treated with tofacitinib achieved clinical remission with few serious adverse events. However, half of patients lost response with de-escalation, which was only partially recaptured with increasing the maintenance dose. Those with negative prognostic factors should be counselled about the risks and benefits of continuing high dose tofacitinib.
First Authors:
Christopher Ma
Correspondence Authors:
Christopher Ma
All Authors:
Christopher Ma,Remo Panaccione,Yasi Xiao,Yuvan Khandelwal,Sanjay K Murthy,Emily CL Wong,Neeraj Narula,Catherine Tsai,Farhad Peerani,Marica Reise-Filteau,Brian Bressler,Samantha Y Starkey,Dustin Loomes,Rocio Sedano,Vipul Jairath,Talat Bessissow,on behalf of the Canadian IBD Research Consortium
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