A Cochrane review [Abstract] 1 included 1 study with 65 subjects. No benefit for induction of remission was noted; clinical remission was observed in 19% (4/21) of patients in the high target serum concentration tacrolimus group, in 9% (2/22) in the low target serum concentration tacrolimus group and in 5% (1/20) in the placebo group (OR 2.27; 95% CI 0.35 to 14.75). Clinical improvement at two weeks was observed in 62% (13/21) of patients in the high target serum concentration group, in 36% (8/22) in the low target serum concentration group and in 10% (2/20) in the placebo group (OR 8.66, 95% CI 1.79 to 42.00). The number of patients that need to be treated with tacrolimus (high or low target serum concentration) versus placebo to induce clinical improvement at two weeks was 3.
Patients in the high serum target concentration group were significantly more likely than placebo patients to experience adverse events related to treatment (P = 0.043). Finger tremor (n = 6) was the most common adverse event in the tacrolimus group. Other adverse events included: gastroenteritis, sepsis, sleepiness, hot flush, headache, queasiness and stomach discomfort. Two patients developed serious side effects during the study.
Comment: The quality of evidence is downgraded by indirectness (there is some concern that patients with less severe disease were enrolled in the trial) and by imprecise results (few patients and wide confidence intervals).
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