Gastroenterología y Reumatología, Fundación Cardiovascular-Hospital Internacional de Colombia, Bucaramanga, Colombia; Grupo de Inmunología Celular y Molecular (INMUBO), Universidad del Bosque, Bogotá, Colombia; Gastroadvanced IPS, Bogotá, Colombia.
Medicina interna, Clínica de Marly, Bogotá, Colombia.
Gastroenterol Hepatol. 2023 Aug-Sep;46(7):512-521. doi: 10.1016/j.gastrohep.2022.10.020. Epub 2022 Nov 11.
There are no studies on efficacy of tofacitinib for ulcerative colitis (UC) in Latin America. The aim of this study was to describe the efficacy and safety, in the real world, of patients with moderate-severe UC treated with tofacitinib in our setting.
Multicenter descriptive observational study, in patients with UC who received treatment with tofacitinib in induction phase for 8 weeks and then, maintenance therapy, between June 2019 and June 2022.
Thirty-four adult patients, 50% female, mean age 38.1 (range 22-72) years. 76.5% pancolitis, and 20.6% left colitis. 79.4% failure to tumor necrosis factor inhibitors (anti-TNFs), and 35.3% to vedolizumab. 14.7% naïve to biologic therapy. 23.5% had previous extraintestinal manifestations. During induction, 58.8% of patients achieved clinical, biochemical and endoscopic remission. During maintenance, 76.9% of patients at 26 weeks and 66.6% at 52 weeks presented clinical remission. Eight patients presented adverse events, none of them cardiovascular or thromboembolic. 44.1% were steroid-dependent, and 23.5% required steroids as rescue therapy. 38.3% required an increase in tofacitinib to 10mg every 12h during maintenance. In 17.6% tofacitinib was discontinued due to lack of efficacy. We included three pediatric-aged female patients, mean age 15.3 (range 14-17) years, 2/3 with pancolitis and 1/3 with left colitis, all with prior exposure to biologic therapy, who had clinical, biologic and endoscopic remission at induction.
In this first Latin American study with tofacitinib in UC, efficacy and safety are demonstrated in the treatment of our patients with moderate to severe activity.
在拉丁美洲，尚无关于托法替布治疗溃疡性结肠炎（UC）疗效的研究。本研究的目的是描述我们的治疗环境中，中重度 UC 患者接受托法替布诱导治疗 8 周后进行维持治疗的疗效和安全性。
这是一项多中心描述性观察研究，纳入了 2019 年 6 月至 2022 年 6 月期间接受托法替布诱导治疗 8 周后进行维持治疗的 UC 患者。
34 例成年患者，50%为女性，平均年龄 38.1 岁（范围 22-72 岁）。76.5%为全结肠炎，20.6%为左半结肠炎。79.4%为肿瘤坏死因子抑制剂（anti-TNFs）治疗失败，35.3%为 vedolizumab 治疗失败。14.7%为初次接受生物治疗。23.5%患者存在既往肠外表现。诱导治疗期间，58.8%的患者达到临床、生化和内镜缓解。维持治疗 26 周时，76.9%的患者和 52 周时 66.6%的患者达到临床缓解。8 例患者出现不良事件，均非心血管或血栓栓塞性不良事件。44.1%为类固醇依赖，23.5%需要类固醇作为挽救治疗。38.3%的患者在维持治疗中需要将托法替布增加至 10mg 每 12 小时。17.6%的患者因疗效不佳而停止使用托法替布。我们纳入了 3 例儿科年龄的女性患者，平均年龄 15.3 岁（范围 14-17 岁），2/3 例为全结肠炎，1/3 例为左半结肠炎，均有生物治疗史，诱导治疗时均达到临床、生物和内镜缓解。
在这项拉丁美洲首例托法替布治疗 UC 的研究中，证实了托法替布治疗中重度活动期 UC 患者的疗效和安全性。
