Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis

B. E. Sands*, W. J. Sandborn, R. Panaccione, C. D. O'Brien, H. Zhang, J. Johanns, O. J. Adedokun, K. Li, L. Peyrin-Biroulet, G. Van Assche, S. Danese, S. Targan, M. T. Abreu, T. Hisamatsu, P. Szapary, C. Marano, Marieke Pierik, UNIFI Study Group

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


BackgroundThe efficacy of ustekinumab, an antagonist of the p40 subunit of interleukin-12 and interleukin-23, as induction and maintenance therapy in patients with ulcerative colitis is unknown.

MethodsWe evaluated ustekinumab as 8-week induction therapy and 44-week maintenance therapy in patients with moderate-to-severe ulcerative colitis. A total of 961 patients were randomly assigned to receive an intravenous induction dose of ustekinumab (either 130 mg [320 patients] or a weight-range-based dose that approximated 6 mg per kilogram of body weight [322]) or placebo (319). Patients who had a response to induction therapy 8 weeks after administration of intravenous ustekinumab were randomly assigned again to receive subcutaneous maintenance injections of 90 mg of ustekinumab (either every 12 weeks [172 patients] or every 8 weeks [176]) or placebo (175). The primary end point in the induction trial (week 8) and the maintenance trial (week 44) was clinical remission (defined as a total score of 1 [range, 0 to 3] on any of the four Mayo scale components).

ResultsThe percentage of patients who had clinical remission at week 8 among patients who received intravenous ustekinumab at a dose of 130 mg (15.6%) or 6 mg per kilogram (15.5%) was significantly higher than that among patients who received placebo (5.3%) (P

ConclusionsUstekinumab was more effective than placebo for inducing and maintaining remission in patients with moderate-to-severe ulcerative colitis. (Funded by Janssen Research and Development; UNIFI number, NCT02407236.)

Original languageEnglish
Pages (from-to)1201-1214
Number of pages14
JournalNew England Journal of Medicine
Issue number13
Publication statusPublished - 26 Sept 2019




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