作者
William J Sandborn, Subrata Ghosh, Julian Panes, Ivana Vranic, Chinyu Su, Samantha Rousell, Wojciech Niezychowski
发表日期
2012/8/16
期刊
New England Journal of Medicine
卷号
367
期号
7
页码范围
616-624
出版商
Massachusetts Medical Society
简介
Background
Ulcerative colitis is a chronic inflammatory disease of the colon for which current treatments are not universally effective. One additional treatment may be tofacitinib (CP-690,550), an oral inhibitor of Janus kinases 1, 2, and 3 with in vitro functional specificity for kinases 1 and 3 over kinase 2, which is expected to block signaling involving gamma chain–containing cytokines including interleukins 2, 4, 7, 9, 15, and 21. These cytokines are integral to lymphocyte activation, function, and proliferation.
Methods
In a double-blind, placebo-controlled, phase 2 trial, we evaluated the efficacy of tofacitinib in 194 adults with moderately to severely active ulcerative colitis. Patients were randomly assigned to receive tofacitinib at a dose of 0.5 mg, 3 mg, 10 mg, or 15 mg or placebo twice daily for 8 weeks. The primary outcome was a clinical response at 8 weeks, defined as an absolute decrease from baseline in the …
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WJ Sandborn, S Ghosh, J Panes, I Vranic, C Su… - New England Journal of Medicine, 2012