Tacrolimus is a potent immunosuppressant agent that inhibits the transcription of IL-2 in T-helper cells, used mainly for the prevention of allograft rejection. Uncontrolled retrospective series suggest its efficacy for treatment of fistulizing CD [47-49]. In the only randomized, double-blind, placebo-controlled trial, Sandborn et al.  randomized 48 patients with actively draining Crohn's fistulae to placebo or oral tacrolimus (initial dosage of 0.20 mg/kg/day for 10 weeks). A clinical response (closure of at least 50% of fistulae maintained for at least 4 weeks) occurred in 43% of tacrolimus-treated patients and 8% of placebo (p=0.004). However, there was no difference in the complete closure of fistulae, (10% of tacrolimus vs. 8% placebo). Adverse events observed in patients treated with tacrolimus include renal insufficiency, tremor, headaches, paresthesias, leg cramps and tremor.
In a subsequent study, ten patients with fistulae refractory to medical therapy (including infliximab) and on long-term steroids or immunosuppressors, were treated with oral tacrolimus (0.05 mg/kg every 12 hours) with 6-24 months follow-up. Four achieved a complete response and five achieved a partial response and could discontinue or reduce steroids and immunosuppressors with no serious side effect .
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