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Rescue therapy with tacrolimus is effective in patients with severe and refractory inflammatory bowel disease
Author(s) -
Baumgart D. C.,
Wiedenmann B.,
Dignass A. U.
Publication year - 2003
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2003.01534.x
Subject(s) - medicine , tacrolimus , pouchitis , ulcerative colitis , inflammatory bowel disease , gastroenterology , refractory (planetary science) , trough level , surgery , disease , transplantation , physics , astrobiology
Summary 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.