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* = Presenting author

P424. Oral tacrolimus for the treatment of refractory inflammatory bowel disease in the biologic era

L. Thin1, K. Murray2, I. Lawrance3, 1Centre for Inflammatory Bowel diseases, Fremantle Hospital, Fremantle, Australia, 2Centre for Applied Statistics, University of Western Australia, Crawly, Australia, 3Centre for Inflammatory Bowel diseases, Fremantle Hospital, University of Western Australia, Fremantle, Australia

Background

Inflammatory bowel disease patients who are refractory to standard therapies frequently require surgery. The long-term efficacy of tacrolimus in patients who fail standard immunosuppressive and anti-TNF alpha therapy is unknown.

Methods

35 patients (11 CD and 24 UC) with medication-resistant disease were treated with oral tacrolimus and reviewed retrospectively. Patients were commenced on tacrolimus 0.1 mg/kg/day, with a trough level targeted between 8–12 ng/ml. Clinical response or remission, at 30-days, 90-days and 1-year were assessed. The overall risk of requiring surgery and predictive factors were also assessed.

Results

All patients had failed a thiopurine, 5 (14%) had also failed methotrexate while 90% had a primary or secondary non-response, or an incomplete response, to an anti-TNF alpha agent. The proportion that achieved a clinical response at 30 days, 90 days and 1 year was 65.7%, 60% and 31.4% respectively, while the corresponding proportions in remission were 40%, 37.1% and 22.9%. The cumulative risk of requiring surgery was 40.4% at one year and 59.3% at two years with a median time to surgery of 22 months (range 0.5–84 months). Patients who were steroid refractory, or dependent, prior to starting tacrolimus were more likely to have surgery (P = 0.006), while patients who were able to achieve or maintain a clinical response with tacrolimus by 90-days were less likely (P = 0.004).

Conclusion

Tacrolimus is able to induce a clinical response in a third and remission in a fifth of medically refractory IBD patients at one year. A 90 day therapeutic trial is worthwhile in difficult to treat patients.