Introduction Previous reports suggest tacrolimus is effective for induction of remission in refractory inflammatory bowel disease (IBD).1 There are limited data regarding the long term outcomes of tacrolimus for inflammatory bowel disease. The authors reviewed the long term experience of patients treated with tacrolimus at a tertiary centre.
Methods In this retrospective, single centre study the authors reviewed the clinical records of 18 adult patients between 2006 and 2010 with refractory IBD (UC 9; CD 8; Pouchitis 1) treated with oral tacrolimus. Clinical activity was evaluated using modified Truelove and Witts Score (mTW), CDAI and PDAI respectively. Response and remission were considered mTW reduction ≥50%/<4 points, CDAI reduction ≥70/CDAI<150 or reduction of PDAI ≥3/PDAI≥7. Tacrolimus was administered orally in all patients (0.1 mg/kg body weight/day) aiming for serum trough levels of 5–10 ng/ml.
Results Mean duration of treatment with tacrolimus was 14.6 months (range 1–50) and mean duration of follow-up was 37.7 months (range 23–67). Mean disease duration for both UC and CD patients was 6 years (range 2–25 years). 7 UC patients had pancolonic and 2 left sided disease. Disease distribution for CD patients was colonic (3); ileocolonic (3); ileal and upper GI disease (1), perianal (1). 2 CD patients had a history of previous surgery. 3/9 UC and 4/8 CD were taking concurrent azathioprine and 4 patients (2 UC, 2 CD) had previously lost response to infliximab therapy.
One patient achieved remission at 3 months, stopped tacrolimus due to renal impairment, but maintained remission up to 54 months on no medication. 5 patients (2 UC, 3 CD) had a sustained response to treatment, but did not achieve remission. 3 other patients (2 UC, 1 CD) stopped treatment due to adverse effects (leucopoenia – 11 months, headache – 6 months, paresthesia – 5 months). The remaining 9 patients lost response to tacrolimus. Three patients (2 UC and 1 CD) showed endoscopic improvement. 6 patients (33%>4 UC, 2 CD) required surgery in the treatment or follow-up period.
Conclusion In our experience, one third of patients treated with long term tacrolimus required surgery. Although a proportion responded to tacrolimus therapy, the majority of patients ultimately required alternative therapies.
- Crohn's disease
- inflammatory bowel disease
- ulcerative colitis.
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Competing interests None.
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