Su1402 Short and Long Term Outcomes of Severe Ulcerative Colitis Patients Treated With Tacrolimus and Infliximab

Abstract

[Background&Aim] The therapeutic strategy of severe ulcerative colitis (UC) is challenging. There are a few studies evaluating the efficacy of tacrolimus (TAC) or infliximab (IFX) in severe UC patients. In current situation, the safety and efficacy of the sequential approaches (TAC→IFX / IFX→TAC) in severe UC patients remain unknown. The aim of this study was to assess short and long term outcomes of severe UC patients treated with TAC and IFX. [Methods] From October 2001 to October 2013, consecutive 29 severe UC patients treated with TAC or IFXwere retrospectively enrolled (mean follow up 27months). Clinical remission was defined as modified Truelove Witts severity index (MTWSI) of less than 5. Clinical response was defined as a decrease of MTWSI of at least 4 points from baseline. TAC was administered orally at the initial dose of 0.1 mg/kg per day and was adjusted to produce whole-blood trough levels of 10 to 15 ng/mL. IFX was administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks as induction therapy and every 8 weeks as maintenance therapy. The primary endpoint of this study was short-term response at 8 weeks after induction of TAC or IFX. Secondary endpoints included colectomy-free survival and treatment safety. Cumulative colectomy free survival was assessed using the Kaplan-Meir method. A univariate analysis was performed to detect the predictive valuables related to colectomy. [Results] Of the 29 patients, 22 and 7 patients were firstly treated with TAC (TAC group) and with IFX (IFX group), respectively. Induction of remission ratio at 8weeks in TAC and IFX group were 64% and 57%, respectively. No significant difference of induction of remission was observed between two groups. During this observational study, in TAC group, 11 patients (50%) kept clinical remission by TAC or thiopurines and 6 patients (27%) required IFX (TAC→IFX) for maintaining clinical remission. In IFX group, 3 patients (43%) kept clinical remission by IFX and 3 patients (43%) required TAC (IFX→TAC) formaintaining clinical remission. Of the 29 patients, 6 patients (21%) required colectomy, and 5 of them did not respond to the sequential approaches. Cumulative colectomy free survival rate was 79.3 % at 118 months. The positivity of CMV-DNA in colonic mucosa was a significant predictor in colectomy. The initial treatment (TAC or IFX), gender, age, extent of disease, MTWSI and endoscopic Mayo score were not predictors in colectomy. No severe adverse event was observed during this observational study. [Conclusion] Our data suggested that treatment with TAC and IFX, and the sequential approaches (TAC→IFX or IFX→TAC) made it possible to avoid colectomy in severe UC patients, although greater consideration should be given to the serious infection.