Author(s): Baumgart DC, Wiedenmann B, Dignass AU
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Abstract BACKGROUND: Oral tacrolimus, approved for the prophylaxis of organ rejection in liver or kidney transplants, has been reported to be effective in anecdotal cases of refractory inflammatory bowel disease. AIM: To evaluate the usefulness of low-dose oral tacrolimus in refractory inflammatory bowel disease. METHODS: Thirty-one adult Caucasian patients with steroid-dependent (n = 15) or steroid-refractory (n = 16) inflammatory bowel disease (Crohn's disease, n = 6; ulcerative colitis, n = 23; pouchitis, n = 2) were enrolled. Tacrolimus (0.1 mg/kg body weight per day) was administered orally in 30 patients and initially intravenously in one patient (0.01 mg/kg body weight per day), aiming for serum trough levels of 4-6 ng/mL. The median treatment duration was 12 months (range, 1-137 months). RESULTS: Twenty-eight patients (90.3\%) experienced a clinical and laboratory response and 20 (64.5\%) went into remission. One ulcerative colitis patient and two Crohn's disease patients did not improve. Three ulcerative colitis patients (9.7\%) were colectomized at 1, 12 and 24 months after tacrolimus initiation. In 19 of 23 patients (82.6\%) taking steroids, steroids were reduced or discontinued. Side-effects included a temporary rise of creatinine (n = 3, 9.7\%), tremor or paraesthesias (n = 3, 9.7\%), hyperkalaemia (n = 1, 3.2\%), hypertension (n = 1, 3.2\%) and an opportunistic infection (n = 1, 3.2\%). CONCLUSION: Oral tacrolimus is safe and effective in refractory inflammatory bowel disease.
This article was published in Aliment Pharmacol Ther
and referenced in International Journal of Inflammation, Cancer and Integrative Therapy