托法替布治疗克罗恩病和 IBD-U 的真实世界疗效和安全性：来自 TROPIC 联盟的多中心研究。
Real-World Effectiveness and Safety of Tofacitinib in Crohn's Disease and IBD-U: A Multicenter Study From the TROPIC Consortium.
机构信息
Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; Division of Gastroenterology, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York.
Division of Gastroenterology and Inflammatory Bowel Diseases Center, Washington University in Saint Louis School of Medicine, St. Louis, Missouri; Division of Internal Medicine, St. Luke's Hospital, St. Louis, Missouri.
出版信息
Clin Gastroenterol Hepatol. 2021 Oct;19(10):2207-2209.e3. doi: 10.1016/j.cgh.2020.10.025. Epub 2020 Oct 14.
Abstract
The safety and efficacy of tofacitinib in Crohn's disease (CD) has been studied in 2 phase II trials in patients with moderate-to-severe CD with no new safety signals observed, but no significant difference from placebo in the primary efficacy endpoint of clinical response. However, post hoc analyses and smaller studies have observed clinical and biologic response to tofacitinib in patients with CD. There is a paucity of real-world effectiveness and safety data for tofacitinib in non-Food and Drug Administration label usage in patients with CD and patients with inflammatory bowel disease-unclassified (IBD-U).
摘要
托法替布在中重度克罗恩病（CD）患者中的安全性和疗效已在两项 II 期临床试验中进行了研究，未观察到新的安全性信号，但在主要疗效终点临床应答方面与安慰剂无显著差异。然而，事后分析和较小的研究观察到 CD 患者使用托法替布后的临床和生物学应答。在非美国食品和药物管理局批准适应证的 CD 患者和未分类炎症性肠病（IBD-U）患者中，托法替布的真实世界疗效和安全性数据较少。
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