Double‐blind, placebo‐controlled trial of oral tacrolimus (FK506) in the management of hospitalized patients with steroid‐refractory ulcerative colitis

@article{Ogata2012DoubleblindPT,
  title={Double‐blind, placebo‐controlled trial of oral tacrolimus (FK506) in the management of hospitalized patients with steroid‐refractory ulcerative colitis},
  author={Haruhiko Ogata and Jun Kato and Fumihito Hirai and Nobuyuki Hida and Toshiyuki Matsui and Takayuki Matsumoto and Katsuyoshi Koyanagi and Toshifumi Hibi},
  journal={Inflammatory Bowel Diseases},
  year={2012},
  volume={18},
  pages={803–808}
}
Background: We report a multicenter study of oral tacrolimus (FK506) therapy in steroid‐refractory ulcerative colitis (UC). Methods: In a placebo‐controlled, double‐blind study, 62 patients with steroid‐refractory, moderate‐to‐severe UC were randomized into either a tacrolimus group or a placebo for 2 weeks. Patients were evaluated using the Disease Activity Index (DAI). As an entry criterion, patients had to have a total DAI score of 6 or more as well as a mucosal appearance subscore of 2 or 3… Expand
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  • G. Boschetti, S. Nancey, +6 authors B. Flourié
  • Medicine
  • Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
  • 2014
TLDR
Oral monotherapy with tacrolimus may be a valuable long-term therapeutic option in selected patients with moderate-to-severe active refractory ulcerative colitis. Expand
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The findings demonstrate dose dependent efficacy and safety of oral tacrolimus for remission-induction therapy of refractory UC and the optimal target range appears to be 10–15 ng/ml in terms of efficacy with two week therapy. Expand
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Long-term tacrolimus therapy appears safe and effective in refractory IBD. Expand
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Tacrolimus induced rapid remission in steroid resistant inflammatory bowel disease in the majority of cases and appears to be an effective treatment modality that may be superior to cyclosporine with respect to maintenance of remission. Expand
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Maintenance therapy with tacrolimus for patients with UC could be considered an alternative to thiopurine therapy in patients with refractory UC. Expand
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Oral tacrolimus (FK 506) was investigated as an alternative drug that can be administered orally for Steroid refractory ulcerative colitis to avoid colectomy. Expand
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