Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis

Stephen Hanauer*, Remo Panaccione, Silvio Danese, Adam Cheifetz, Walter Reinisch, Peter D.R. Higgins, Deborah A. Woodworth, Haiying Zhang, Gary S. Friedman, Nervin Lawendy, Daniel Quirk, Chudy I. Nduaka, Chinyu Su

*Corresponding author for this work

Research output: Contribution to journalArticle

40 Scopus citations

Abstract

Background & Aims: Tofacitinib is an oral, small molecule inhibitor of JAK for the treatment of ulcerative colitis (UC). We evaluated the onset of symptom improvement in post-hoc analyses of data from 2 phase 3 trials of induction therapy with tofacitinib in patients with UC (OCTAVE Induction 1 and 2). Methods: The studies comprised patients with moderate to severe active UC who were intolerant to, or failed by previous treatment with, corticosteroids, thiopurines, and/or tumor necrosis factor (TNF) antagonists. Patients received tofacitinib (10 mg twice daily, n = 905) or placebo (n = 234) for 8 weeks. Daily Mayo stool frequency and rectal bleeding subscores were calculated using diary data from the first 15 days of therapy. We analyzed data from subgroups including failure of prior anti-TNF therapy, baseline corticosteroid use, and baseline serum levels of C-reactive protein. Results: Mean changes were significantly greater in patients given tofacitinib vs placebo in reductions from baseline stool frequency subscore (tofacitinib: –0.27 vs placebo: –0.11; P < .01), total number of daily bowel movements (–1.06 vs –0.27; P < .0001), and rectal bleeding subscore (–0.30 vs –0.14; P < .01) by day 3. Compared with placebo, more tofacitinib-treated patients had reductions from baseline in stool frequency subscore (by ≥1 point for tofacitinib, 241/837, 28.8% vs placebo, 39/218, 17.9%) (P < .01) and rectal bleeding subscore (by ≥1 point for tofacitinib, 266/830, 32.0% vs placebo, 43/214, 20.1%) (P < .01) by day 3. A consistent effect of tofacitinib was observed in all subgroups. Conclusions: In a post-hoc analysis of data from phase 3 trials of induction therapy with tofacitinib in patients with UC, we found significant improvements in symptoms among patients given tofacitinib compared with placebo within 3 days. These findings indicate the rapid onset of effect of this drug in patients with UC. ClinicalTrials.gov no: NCT01465763 and NCT01458951.

Original languageEnglish (US)
Pages (from-to)139-147
Number of pages9
JournalClinical Gastroenterology and Hepatology
Volume17
Issue number1
DOIs
StatePublished - Jan 2019

Keywords

  • Efficacy
  • IBD
  • Inflammatory Bowel Disease
  • Onset of Action

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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    Hanauer, S., Panaccione, R., Danese, S., Cheifetz, A., Reinisch, W., Higgins, P. D. R., Woodworth, D. A., Zhang, H., Friedman, G. S., Lawendy, N., Quirk, D., Nduaka, C. I., & Su, C. (2019). Tofacitinib Induction Therapy Reduces Symptoms Within 3 Days for Patients With Ulcerative Colitis. Clinical Gastroenterology and Hepatology, 17(1), 139-147. https://doi.org/10.1016/j.cgh.2018.07.009