D C Baumgart1, B Wiedenmann, A U Dignass. 1. Charité Medical Center-Virchow Hospital, Medical School of the Humboldt University of Berlin, Department of Medicine, Division of Hepatology and Gastroenterology, Berlin, Germany.
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.
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 colitispatient and two Crohn's diseasepatients did not improve. Three ulcerative colitispatients (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.
Authors: A Grabig; D Paclik; C Guzy; A Dankof; D C Baumgart; J Erckenbrecht; B Raupach; U Sonnenborn; J Eckert; R R Schumann; B Wiedenmann; A U Dignass; A Sturm Journal: Infect Immun Date: 2006-07 Impact factor: 3.441
Authors: Jolanda M van Dieren; Margaretha E H Lambers; Ernst J Kuipers; Janneke N Samsom; C Janneke van der Woude; Edward E S Nieuwenhuis Journal: Dig Dis Sci Date: 2009-12-01 Impact factor: 3.199