JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

Long-term effect of tacrolimus therapy in patients with refractory ulcerative colitis

S Yamamoto, H Nakase, S Mikami, S Inoue, T Yoshino, Y Takeda, K Kasahara, S Ueno, N Uza, H Kitamura, H Tamaki, M Matsuura, K Inui, T Chiba
Alimentary Pharmacology & Therapeutics 2008 September 1, 28 (5): 589-97
18549460

BACKGROUND: Little is known about long-term outcome of tacrolimus therapy for ulcerative colitis. Aim To evaluate long-term efficacy and safety of tacrolimus in Japanese patients with refractory ulcerative colitis.

METHODS: Twenty-seven patients with UC refractory to conventional therapy were administered tacrolimus with trough whole-blood levels of 10-15 ng/mL to induce remission and 5-10 ng/mL to maintain remission. Median treatment duration was 11 months (1-39 months) and median follow-up duration was 17 months (2-65 months). Evaluation of the clinical response was based on a modified Truelove-Witts severity index (MTWSI).

RESULTS: Tacrolimus produced a clinical response in 21 patients (77.8%), and remission was achieved in 19 of these 21 (70.4%) within 30 days. Overall cumulative colectomy-free survival was estimated as 62.3% at 65 months. In 18 of 19 patients treated with corticosteroids at the initiation of tacrolimus therapy, corticosteroids were discontinued or tapered. Adverse events were tremor (25.9%), renal function impairment (18.5%), infectious disease (14.8%), hot flashes (11.1%), hyperkalaemia (7.4%), headache (7.4%), epigastralgia (7.4%) and nausea (3.7%). No mortality occurred.

CONCLUSION: Long-term administration of tacrolimus appears to be an effective and well-tolerated treatment for Japanese patients with refractory ulcerative colitis.

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