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


Dr H. Nakase, Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, 54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan.
E-mail: hiropy_n@kuhp.kyoto-u.ac.jp


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.