Systematic review: the role of tacrolimus in the management of Crohn's disease

Aliment Pharmacol Ther. 2011 Dec;34(11-12):1282-94. doi: 10.1111/j.1365-2036.2011.04873.x. Epub 2011 Oct 17.


BACKGROUND Several published studies have evaluated the efficacy of tacrolimus in the management of Crohn's disease with variable conclusions. AIM To review systematically the evidence examining the efficacy and safety of tacrolimus in treating Crohn's disease. METHODS The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PUBMED) and EMBASE (1984 to January 2011) were searched. Also, references from selected articles were examined. Case series (five or more patients), cohort and randomised controlled trials were eligible for inclusion, incorporating oral, intravenous or topical tacrolimus therapy. The primary outcome was induction of remission of active Crohn's disease. RESULTS Eleven studies met the inclusion criteria which included 163 patients, of which 127 received tacrolimus therapy. In patients with luminal Crohn's disease, the crude pooled remission rate for tacrolimus was 44.3% (range, 7-69%) and the crude pooled response rate was 37.1% (range, 14-57%). For patients with perianal disease using systemic tacrolimus, crude pooled remission rate was 28.6% (range, 0-64%) and crude pooled response rate was 38.8% (range, 0-57%). Combining data from two studies using topical tacrolimus, 35.7% of patients achieved remission and 28.6% partial response. Nonserious adverse effects are common, particularly tremor, paraesthesia and headache. Reversible nephrotoxity occurred in 16% of patients. CONCLUSIONS The current evidence; although of a poor quality, appears to support the use of tacrolimus in Crohn's disease. High quality randomised controlled trials are needed.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Crohn Disease / drug therapy*
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Randomized Controlled Trials as Topic
  • Tacrolimus / therapeutic use*
  • Treatment Outcome


  • Immunosuppressive Agents
  • Tacrolimus