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Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials.

  • Panés, Julian1
  • Sandborn, William J2
  • Schreiber, Stefan3
  • Sands, Bruce E4
  • Vermeire, Séverine5
  • D'Haens, Geert6
  • Panaccione, Remo7
  • Higgins, Peter D R8
  • Colombel, Jean-Frederic4
  • Feagan, Brian G9
  • Chan, Gary10
  • Moscariello, Michele10
  • Wang, Wenjin10
  • Niezychowski, Wojciech10
  • Marren, Amy10
  • Healey, Paul11
  • Maller, Eric10
  • 1 Hospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain. , (Spain)
  • 2 Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, California, USA.
  • 3 Klinik für Innere Medizin I, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany. , (Germany)
  • 4 Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
  • 5 Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium. , (Belgium)
  • 6 Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. , (Netherlands)
  • 7 Department of Medicine, University of Calgary, Calgary, Alberta, Canada. , (Canada)
  • 8 Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.
  • 9 Robarts Research Institute, London, Ontario, Canada. , (Canada)
  • 10 Pfizer Inc, Collegeville, Pennsylvania, USA.
  • 11 Pfizer Inc, Groton, Connecticut, USA.
Published Article
Publication Date
Jun 01, 2017
DOI: 10.1136/gutjnl-2016-312735
PMID: 28209624


Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks. Those achieving clinical response-100 or remission were re-randomised to maintenance treatment with placebo, tofacitinib 5 or 10 mg twice daily for 26 weeks. Primary endpoints were clinical remission at the end of the induction study, and clinical response-100 or remission at the end of the maintenance study. 180/280 patients randomised in the induction study were enrolled in the maintenance study. At week 8 of induction, the proportion of patients with clinical remission was 43.5% and 43.0% with 5 and 10 mg twice daily, respectively, compared with 36.7% in the placebo group (p=0.325 and 0.392 for 5 and 10 mg twice daily vs placebo). At week 26 of maintenance, the proportion of patients with clinical response-100 or remission was 55.8% with tofacitinib 10 mg twice daily compared with 39.5% with tofacitinib 5 mg twice daily and 38.1% with placebo (p=0.130 for 10 mg twice daily vs placebo). Compared with placebo, the change in C-reactive protein from baseline was statistically significant (p<0.0001) with 10 mg twice daily after both induction and maintenance treatments. Primary efficacy endpoints were not significantly different from placebo, although there was evidence of a minor treatment effect. No new safety signals were observed for tofacitinib. NCT01393626 and NCT01393899. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

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