P451. Long-term follow-up in patients with ulcerative colitis treated with tacrolimus: early and long-term data from a retrospective observational study
M. Matsuura1, H. Nakase1, T. Yoshino1, T. Chiba1, 1Graduate School of Medicine, Kyoto University, Department of Gastroenterology and Hepatology, Kyoto, Japan
Background
Calcineurin inhibitors, such as cyclosporin and tacrolimus, are used for rescue therapy for acute severe ulcerative colitis (UC). Rescue therapy with tacrolimus helps avoid colectomy in a substantial proportion of patients with refractory UC, but the impact on long-term outcome remains unclear. The aim of this study is to evaluate the long-term outcome of tacrolimus on patients with refractory UC.
Methods
We reviewed our series of refractory UC treated with tacrolimus from October 2001 to October 2012. Tacrolimus was administered orally or intravenously, and the dose of tacrolimus was adjusted with trough whole-blood levels of 10–15 ng/ml for induction of remission and 5–10 ng/ml for maintenance. Tacrolimus was kept in responder for at least 3 months and until completely tapering corticosteroids, and then switched to thiopurine drugs. Infliximab was used as rescue therapy for patients with UC who flared-up under those immunosuppressive treatments. We evaluated: 1) the rate of clinical remission at 30 days after starting tacrolimus; 2) proportion of patients requiring infliximab treatment; 3) colectomy rate at 6 month, 12 months and at the end of the follow-up. Disease activity was evaluated using a modified Truelove–Witts severity index (MTWSI), and clinical remission was defined as MTWSI score of 4 or less.
Results
Fifty refractory UC patients treated with tacrolimus were evaluated (median age 32 years [range 16–73 years]). Median treatment duration was 10 months (range 1–75 months) and median follow-up duration was 24 months (range 2–107 months). Thirty-three patients (33/50, 66.6%) achieved clinical remission at 30 days after initiation tacrolimus. Six of 17 patients who did not respond within 30 days (6/17; 35.2%) required infliximab treatment, and 4 of 6 infliximab-treated patients avoided colectomy during follow-up periods. Colectomy rate at 6 months, 12 months, the end of follow-up were 5% (5/50), 12% (6/50), 14% (7/50), respectively. We could not determine the predictive factors for early responsiveness of tacrolimus and avoidance of colectomy.
Conclusion
Our long-term observational study demonstrated that tacrolimus could be an effective rescue therapy for patients with refractory UC in the point of avoiding colectomy.