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指南审查:托法替布用于中度至重度活动性溃疡性结肠炎成人患者——英国国家卫生与临床优化研究所指南

Guideline review: Tofacitinib for adults with moderately to severely active ulcerative colitis - NICE guidance.

作者信息

Nwaogu Akudo, Bond Ashley, Smith Philip J

机构信息

Department of Medicine, Royal London Hospital, Barts Health NHS Trust, London, London, UK.

Department of Gastroenterology, Royal Liverpool and Broadgreen Hospitals NHS Trust, Liverpool, UK.

出版信息

Frontline Gastroenterol. 2020 Jun 10;12(2):133-136. doi: 10.1136/flgastro-2020-101502. eCollection 2021.

Abstract

Tofacitinib is an oral, Janus kinase (JAK) molecule, which selectively inhibits Janus-associated tyrosine kinases JAK1 and JAK3. It has already shown efficacy in the treatment of rheumatoid arthritis and the prevention of organ allograft rejection in kidney transplantation. Two separate phase III placebo-controlled trials, assessing 8-week efficacy of tofacitinib induction for ulcerative colitis (UC), demonstrated superiority when compared with placebo. Tofacitinib also demonstrated robust efficacy versus placebo in the 52-week maintenance component of the same study. Tofacitinib has been recommended by the National Institute for Health and Care Excellence as an effective treatment option for adult patients with moderate to severe UC when conventional therapy or a biological agent cannot be tolerated or the disease has responded inadequately or lost response to treatment. We review the guidelines and provide brief commentary on the post hoc analysis related to lipid increases and thromboembolism risk, which have lead to changes in current therapeutic guidance.

摘要

托法替布是一种口服的 Janus 激酶(JAK)分子,它可选择性抑制 Janus 相关酪氨酸激酶 JAK1 和 JAK3。它已在类风湿关节炎治疗及肾移植中预防器官移植排斥方面显示出疗效。两项独立的 III 期安慰剂对照试验评估了托法替布诱导治疗溃疡性结肠炎(UC)8 周的疗效,结果显示与安慰剂相比具有优势。在同一研究的 52 周维持治疗阶段,托法替布与安慰剂相比也显示出强大疗效。英国国家卫生与临床优化研究所已推荐托法替布作为成年中重度 UC 患者的有效治疗选择,适用于无法耐受传统疗法或生物制剂,或疾病对治疗反应不佳或失去反应的情况。我们回顾了相关指南,并对与血脂升高和血栓栓塞风险相关的事后分析提供简要评论,这些分析导致了当前治疗指南的变化。

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