title: Rescue therapy with tacrolimus is effective in patients with severe and refractory inflammatory bowel disease.
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.
  
  
  OBJECTIVE
  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%).
  
  
  CONCLUSIONS
  Oral tacrolimus is safe and effective in refractory inflammatory bowel disease.
authors.affiliation: Charité Medical Center-Virchow Hospital, Medical School of the Humboldt University of Berlin, Department of Medicine, Division of Hepatology and Gastroenterology, Berlin, Germany.
authors.forename: D C
authors.initials: DC
authors.lastname: Baumgart
authors.forename: B
authors.initials: B
authors.lastname: Wiedenmann
authors.forename: A U
authors.initials: AU
authors.lastname: Dignass
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015212:Inflammatory Bowel Diseases / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013256:Steroids / Q000627:therapeutic use; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D007166:Immunosuppressive Agents; D013256:Steroids; D016559:Tacrolimus