Department of Biomedical Sciences, Humanitas University, Milan, Italy.
IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, Milan, Italy.
Inflamm Bowel Dis. 2018 Sep 15;24(10):2106-2112. doi: 10.1093/ibd/izy076.
Treatment options for ulcerative colitis (UC) remain limited because conventional therapies do not succeed at controlling the disease in a considerable percentage of patients, while up to 30% of those receiving biologics are primary nonresponders and 10%-20% lose response per year, requiring an increase in the treatment dose or the use of a different drug. Recently, tofacitinib, an orally administered small molecule that inhibits the Janus kinases, was proven efficacious for inducing and maintaining remission in adult patients with moderate to severe UC. Tofacitinib may represent a therapeutic alternative for the management of UC, pending approval by the US Food and Drug Administration, the European Medicines Agency, and other international regulatory authorities. Herein, we review tofacitinib's efficacy and safety data reported from randomized controlled trials in UC populations, with the aim to define how this new molecule could be inserted into the therapeutic algorithm of patients with UC.
溃疡性结肠炎(UC)的治疗选择仍然有限,因为传统疗法不能在相当一部分患者中控制疾病,而接受生物制剂治疗的患者中多达 30%是原发性无应答者,每年有 10%-20%失去应答,需要增加治疗剂量或使用不同的药物。最近,一种口服小分子药物托法替尼(tofacitinib)已被证明可有效诱导和维持中重度 UC 成年患者的缓解。托法替尼可能代表了一种治疗 UC 的新方法,有待美国食品药品监督管理局、欧洲药品管理局和其他国际监管机构的批准。本文综述了托法替尼在 UC 人群的随机对照试验中报告的疗效和安全性数据,旨在确定如何将这种新分子纳入 UC 患者的治疗方案。