1. Ustekinumab as Induction and Maintenance Therapy for Crohn’s Disease
- Author
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Feagan, BG, Sandborn, WJ, Gasink, C, Jacobstein, D, Lang, Y, Friedman, JR, Blank, MA, Johanns, J, Gao, L-L, Miao, Y, Adedokun, OJ, Sands, BE, Hanauer, SB, Vermeire, S, Targan, S, Ghosh, S, de Villiers, WJ, Colombel, J-F, Tulassay, Z, Seidler, U, Salzberg, BA, Desreumaux, P, Lee, SD, Loftus, EV, Dieleman, LA, Katz, S, and Rutgeerts, P
- Abstract
BACKGROUND\ud Ustekinumab, a monoclonal antibody to the p40 subunit of interleukin-12 and inter-leukin-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.\ud METHODS\ud 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 \ud these induction trials then participated in IM-UNITI, in which the 397 patients who had a response to ustekinumab were randomly assigned to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 8 weeks or every 12 weeks) or placebo. The primary end point for the induction trials was a clinical response at week 6 (defined as a decrease from baseline in the Crohn’s Disease Activity Index [CDAI] score of ≥100 points or a CDAI score
- Published
- 2016