Supported by Astellas Pharma Inc., Japan, through financial grants, whereby each participating study site (not individual site investigators) received fixed-part reimbursement for every patient enrolled, covering the additional costs of the trial.
Double-blind, placebo-controlled trial of oral tacrolimus (FK506) in the management of hospitalized patients with steroid-refractory ulcerative colitis†
Article first published online: 1 SEP 2011
Copyright © 2011 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 18, Issue 5, pages 803–808, May 2012
How to Cite
Ogata, H., Kato, J., Hirai, F., Hida, N., Matsui, T., Matsumoto, T., Koyanagi, K. and Hibi, T. (2012), Double-blind, placebo-controlled trial of oral tacrolimus (FK506) in the management of hospitalized patients with steroid-refractory ulcerative colitis. Inflamm Bowel Dis, 18: 803–808. doi: 10.1002/ibd.21853
- Issue published online: 12 APR 2012
- Article first published online: 1 SEP 2011
- Manuscript Accepted: 13 JUL 2011
- Manuscript Received: 24 MAR 2011
- ulcerative colitis;
- immunosuppressive therapy;
We report a multicenter study of oral tacrolimus (FK506) therapy in steroid-refractory ulcerative colitis (UC).
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. Clinical response was defined as improvement in all DAI subscores. Mucosal healing was defined as mucosal appearance subscore of 0 or 1. Clinical remission was defined as a total DAI score ≤2 with an individual subscore of 0 or 1.
The mean total DAI score at study entry was 9.8 ± 1.61 in the tacrolimus group and 9.1 ± 1.05 in the placebo group. At week 2 the clinical response rate was 50.0% (16/32) in the tacrolimus group and 13.3% (4/30) in the placebo group (P = 0.003). The rate of mucosal healing observed was 43.8% (14/32) in the tacrolimus group and 13.3% (4/30) in the placebo group (P = 0.012) and the rate of clinical remission observed was 9.4% (3/32) in the tacrolimus group and 0.0% (0/30) in the placebo group (P = 0.238). The therapies in this study were well tolerated, with only minor side effects.
Oral tacrolimus therapy in patients with steroid-refractory UC shortened the acute phase and induced rapid mucosal healing. These results suggest that tacrolimus therapy is useful as an alternative therapy for steroid-refractory UC. (Inflamm Bowel Dis 2011;)