Tacrolimus for Refractory Crohn’s Disease

While tacrolimus has been considered a potential option for refractory Crohn’s, data on its usage are sparse, mostly small retrospective studies.  Another small retrospective study from the Mayo clinic provides data from their experience with 24 adult patients who were treated with tacrolimus for a median of 4 months (Inflamm Bowel Dis 2013; 19: 1107-11).

17 (71%) of study participants were female and their median age was 38 years.  18 (75%) had ileocolonic disease.  All patients were either intolerant or unresponsive to at least one anti-TNFα agent.  Most patients received concurrent therapy: thiopurines (58%), methotrexate (8%) and antibiotics (46%).


  • 67% responded to tacrolimus and 21% achieved a steroid-free remission.
  • Patients with trough levels of 10 to 15 ng/mL had the highest response (86%) and remission (57%).
  • Adverse events were common (75% of patients); 8 (33%) required dose reduction and 6 (25%) led to treatment discontinuation.  Frequent adverse events included acute kidney injury (29%), paresthesia (29%), headache (17%), and tremor (17%).
  • 54% of patients in this series required surgery within a median of 10 months after starting tacrolimus.
  • Of the patients who achieved remission (n=5), 2 were transitioned to immunomodulator therapy to minimize long-term toxicity. 1 patient did well after stopping all therapy during a 6 month followup.  1 patient stopped treatment due to paresthesias and 1 patient continued therapy for 2.5 years.

The study does not describe the use of antibiotics for the prevention of Pneumocystis jiroveci pneumonia.

Take-home message: Tacrolimus doesn’t look too promising for refractory disease.

Related blog post:

Additional references:

  • -IBD 2008; 14: 7-12. Tacrolimus of minimal efficacy for UC and Crohn’s. Some achieve response (22/32 in UC and 7/15 in Crohn’s) only 3/32 UC with remission and 1/15 Crohn’s with remission
  • -Gut 2006; 55: 1255-1262. Use of prograf in refractory UC. Troughs 10-15, then 5-10 after remission; partial response in 68% at week 2 & 58% at week 10 (n=19)
  • -Gastroenterol 2003; 125: 380. Tacrolimus helped but did not cure fistulizing disease
  • -J Pediatr 2000; 137: 794-799. n=14.
  • -Am J Gastro 1997; 92: 876. Use in fistualizing Crohn’s.
  • -Am J Gastro 1998; 93: 18. Use in IBD.
  • -IBD 1999; 5: 239. Combined c azathioprine for perianal fistulae. response: initial 2.4weeks, 12.2weeks complete. 7/11 c complete response.
  • -IBD 2009; 15: 193. topical tacrolimus for proctitis. 10/12 w proctitis responded to 2 mg or 4 mg enema in 100 mL of sterile water.
  • -IBD 2007; 13: 245. Use for perianal disease.
  • -Gut 2000; 47: 436-440. Topical tacrolimus may be effective in the treatment of oral and perineal Crohn’s disease.

1 thought on “Tacrolimus for Refractory Crohn’s Disease

  1. Pingback: IBD Shorts and Postop Crohn’s Management | gutsandgrowth

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