Oral Tacrolimus Effective in Refractory Ulcerative Colitis

Dose-dependent improvement in patients with moderate, severe disease

MONDAY, Sept. 11 (HealthDay News) -- Oral tacrolimus can reduce symptoms as well as the need for prednisolone in patients with refractory ulcerative colitis, according to the results of a placebo-controlled study published in the September issue of Gut.

Hisao Ogata, M.D., of Keio University School of Medicine in Tokyo, Japan, and colleagues randomized 63 patients to placebo, high trough (10 to 15 ng/mL) or low trough concentrations (5 to 10 ng/mL) of oral tacrolimus for two weeks. An additional 10 weeks of treatment with tracrolimus was provided to 58 of the patients in an open-label extension trial.

After two weeks, 68.4 percent of the high-trough group showed an improvement in disease activity index of four or more points, compared with 10 percent of the placebo group. Clinical remission occurred in 29.3 percent and mucosal healing in 72.7 percent of tacrolimus-treated patients at the end of the study. All patients had a mean reduction in prednisolone doses from 19.7 mg/day to 7.8 mg/day; steroid-resistant patients' mean doses fell from 33.8 mg/day to 9.5 mg/day.

"The optimal target blood trough concentration range of tacrolimus appears to be 10 to 15 ng/mL in terms of efficacy with two week therapy. Longer term tacrolimus treatment (more than three months) is now under investigation," the authors write.

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