Tacrolimus vs. anti-tumour necrosis factor agents for moderately to severely active ulcerative colitis: a retrospective observational study

Aliment Pharmacol Ther. 2016 Mar;43(6):705-16. doi: 10.1111/apt.13531. Epub 2016 Jan 13.


Background: There have been no comparative studies of tacrolimus vs. anti-tumour necrosis factor (anti-TNF) agents to determine which treatment is safer or more effective in refractory ulcerative colitis (UC).

Aim: To compare short-term safety and efficacy of tacrolimus vs. anti-TNF agents for active UC.

Methods: One hundred patients with moderate-to-severe active UC were studied. Fifty patients were treated with oral tacrolimus (TAC group). The other 50 patients were treated with anti-TNF agents (anti-TNF group): 40 with infliximab and 10 with adalimumab. Primary endpoints were clinical response and remission rates, colectomy rate, and the incidence of adverse events during 12 weeks.

Results: The incidence of adverse events was 12% in the TAC vs. 18% in the anti-TNF groups (P = 0.58). At week 12, clinical remission rate was 40% in the TAC vs. 28% in the anti-TNF groups (P = 0.29). Clinical response (including remission) rate was 62% in the TAC vs. 64% in the anti-TNF groups (P > 0.99). Five patients (10%) in the TAC and 8 (16%) in the anti-TNF groups required colectomy (P = 0.55). In a subgroup analysis restricted to severely active UC, the response rate was 50% in the TAC vs. 25% in the anti-TNF groups (P = 0.24). In severely active UC, the response rate tended to be higher in patients treated with tacrolimus, albeit not statistically significant.

Conclusions: Both tacrolimus and anti-TNF agents appeared to be safe and effective in the management of moderate-to-severe active UC. However, randomised controlled trials are warranted to confirm the results obtained in this study.

Publication types

  • Observational Study

MeSH terms

  • Adalimumab / adverse effects
  • Adalimumab / therapeutic use*
  • Adult
  • Colitis, Ulcerative / drug therapy*
  • Female
  • Humans
  • Infliximab / adverse effects
  • Infliximab / therapeutic use*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Tacrolimus / therapeutic use*
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*


  • Tumor Necrosis Factor-alpha
  • Infliximab
  • Adalimumab
  • Tacrolimus