Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme
Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme
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DOI：
10.1111/apt.15514
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发表时间：
2019-11-01
影响因子：
7.6
通讯作者：
Danese, Silvio
中科院分区：
文献类型：
--
作者：
Sandborn, William J.;Panes, Julian;Danese, Silvio
背景托法替尼是一种口服小分子JAK抑制剂，用于治疗溃疡性结肠炎（UC）。目的报告托法替尼UC项目中深静脉血栓形成（DVT）和肺栓塞（PE）的发生率。方法从一项II期和两项III期诱导研究、一项III期维持研究和一项正在进行的开放标签长期扩展（OLE）研究（2018年9月datacut）中评价DVT和PE。对诱导期、维持期和总体（接受≥ 1剂托法替布5或10 mg b.d.在任何2期、3期或OLE研究中）组群。结果1157例患者（2404患者年暴露量;
Background Tofacitinib is an oral, small molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Aim To report incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the tofacitinib UC programme. Methods DVT and PE were evaluated from one phase 2 and two phase 3 induction studies, one phase 3 maintenance study and an ongoing, open-label, long-term extension (OLE) study (September 2018 datacut). Data were analysed in induction, maintenance and overall (patients receiving >= 1 dose of tofacitinib 5 or 10 mg b.d. in any phase 2, 3 or OLE study) cohorts. Results 1157 patients (2404 patient-years' exposure;