作者
William J Sandborn, Subrata Ghosh, Julian Panes, Ivana Vranic, Wenjin Wang, Wojciech Niezychowski, Severine ARA Vermeire, Olivier Dewit, Harald Peeters, Jiri Stehlik, Tomas Vanasek, David Laharie, Jean Frederic Colombel, Marc-André Bigard, Marta Varga, Margit Zeher, Janos Novak, Bela Hunyady, Agnes Salamon, Istvan Racz, Paolo Gionchetti, Anna Kohn, Cosimo Prantera, PCF Stokkers, Maria Slomka, Leszek Paradowski, Tomasz Arlukowicz, Ladislav Kuzela, Boris Baricky, Tibor Hlavaty, Maria Isabel Vera, Jordi Guardiola, Christopher Probert, Jonathan Lionel Shaffer, Mark Fleisher, Ronald Edward Pruitt, John Sawyer Goff, John Weber, Raymond Lloyd Bell, Andrew Harrison Zwick, Alexandra Gutierrez, Robert H Levine, Stephen Brett Hanauer, Lori Ann Lavelle, Ravindranath K Kottoor, Gerald Wayne Dryden Jr, Robert Hardi, David Vaughn Glorioso, Prabhakar Swaroop, Scott D Lee, Teressa Joan Patrick, Sheldon Scheinert, Charles A Sninsky, Seymour Katz, Mark D Noar, Michael Marion Gaspari, Glenn L Gordon, Thomas A Dalton, Douglas Edward Homoky, William Ransom Kilgore III, Joel A Levien, Herbert R Schneider, Suleman Abdul Moola, Frederik Cornelius Kruger, John P Wright, Nazimuddin Aboo
发表日期
2014/9/1
期刊
Clinical gastroenterology and hepatology
卷号
12
期号
9
页码范围
1485-1493. e2
出版商
WB Saunders
简介
Background & Aims
Tofacitinib, an orally administered Janus kinase inhibitor, blocks signaling through γ-chain–containing cytokines (interleukins 2, 4, 7, 9, 15, and 21). We performed a phase 2 trial to measure its efficacy in patients with moderate-to-severe active Crohn’s disease.
Methods
Patients (N = 139; age, ≥18 y) with moderate-to-severe active Crohn’s disease were assigned randomly to groups given 1 mg (n = 36), 5 mg (n = 34), or 15 mg (n = 35) tofacitinib or placebo (n = 34), twice daily for 4 weeks, at 48 centers in 12 countries. The primary end point was the proportion of clinical responders at week 4 (decrease from baseline in the Crohn’s Disease Activity Index score of ≥70 points [Response-70]). Secondary end points included clinical remission (Crohn’s Disease Activity Index score of <150 points) at week 4.
Results
A clinical response was observed in 36% (P = .467), 58% (P = .466), and 46% (P ≥ .999 …
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WJ Sandborn, S Ghosh, J Panes, I Vranic, W Wang… - Clinical gastroenterology and hepatology, 2014