作者
Brian G Feagan, William J Sandborn, Christopher Gasink, Douglas Jacobstein, Yinghua Lang, Joshua R Friedman, Marion A Blank, Jewel Johanns, Long-Long Gao, Ye Miao, Omoniyi J Adedokun, Bruce E Sands, Stephen B Hanauer, Severine Vermeire, Stephan Targan, Subrata Ghosh, Willem J De Villiers, Jean-Frédéric Colombel, Zsolt Tulassay, Ursula Seidler, Bruce A Salzberg, Pierre Desreumaux, Scott D Lee, Edward V Loftus Jr, Levinus A Dieleman, Seymour Katz, Paul Rutgeerts
发表日期
2016/11/17
期刊
New England journal of medicine
卷号
375
期号
20
页码范围
1946-1960
出版商
Massachusetts Medical Society
简介
Background
Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin-12 and interleukin-23, was evaluated as an intravenous induction therapy in two populations with moderately to severely active Crohn’s disease. Ustekinumab was also evaluated as subcutaneous maintenance therapy.
Methods
We randomly assigned patients to receive a single intravenous dose of ustekinumab (either 130 mg or approximately 6 mg per kilogram of body weight) or placebo in two induction trials. The UNITI-1 trial included 741 patients who met the criteria for primary or secondary nonresponse to tumor necrosis factor (TNF) antagonists or had unacceptable side effects. The UNITI-2 trial included 628 patients in whom conventional therapy failed or unacceptable side effects occurred. Patients who completed these induction trials then participated in IM-UNITI, in which the 397 patients who had a response to …
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BG Feagan, WJ Sandborn, C Gasink, D Jacobstein… - New England journal of medicine, 2016