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J Gastroenterol. 2008;43(10):774-9. doi: 10.1007/s00535-008-2229-y. Epub 2008 Oct 29.

The effect of tacrolimus (FK-506) on Japanese patients with refractory Crohn's disease.

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  • 1Department of Gastroenterology & Hepatology, Graduate School of Medicine, Kyoto University, 54 Kawara, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan.



Recent evidence indicates that intravenous or oral therapy with tacrolimus (FK-506) is effective in treating patients with Crohn's disease. We evaluated the usefulness of tacrolimus therapy for Japanese patients with refractory Crohn's disease.


Fourteen adult Japanese patients with Crohn's disease that was refractory to conventional therapies, including prednisolone (n = 5), azathioprine (n = 6), and infliximab (n = 5), were enrolled. Treatment with tacrolimus was started orally or intravenously and aimed for serum trough levels of 10-15 ng/ml. After the patients achieved clinical improvement, tacrolimus maintenance therapy was administered to maintain the trough level at 5-10 ng/ml.


All patients achieved remission or significant improvement 40 days after starting tacrolimus treatment. By 120 days after the start of therapy, 9 (64%) patients achieved remission, 2 patients (14%) achieved significant improvement, and only 3 patients (21%) relapsed. The relapsed patients were treated with infliximab therapy and achieved remission. Steroids were discontinued by the 5 patients who had taken steroids before the study began. Adverse effects of tacrolimus included a temporary increase in serum creatinine concentration (n = 1, 7%), hyperkalemia (n = 1, 7%), and tremor (n = 1, 7%).


Tacrolimus therapy is effective and well tolerated in patients with Crohn's disease that is refractory to conventional therapies.

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