1125 Oral Tacrolimus Versus Cyclosporine a in Patients With Moderate to Severe Ulcerative Colitis Refractory to Corticosteroids

Abstract

BACKGROUND: There are limited treatment options for patients with corticosteroid refractory ulcerative colitis (UC). Tacrolimus belongs to a group ofmedicines known as immunosuppressive agents. Animal models of inflammatory bowel disease and uncontrolled studies in humans suggest that Tacrolimus may be an effective medication for patients with UC. Accordingly, although almost exclusively used in trial cases, Tacrolimus has shown significant efficacy in the suppression of UC relapse. This study compared the efficacy of oral Tacrolimus vs Cyclosporine (Cs)A in patients with UC, refractory to corticosteroids. METHODS: Between January 2006 and January 2011, a total of 113 patients with UC, all corticosteroid refractory were included in this study. The patients were randomly assigned to two groups, CsA (n= 80; 40 male and 40 female, average age 34.7 ± 13.9 years) and Tacrolimus (n=33, 23 male and 10 female, average age 41.4 ± 15.7 years). Lichtiger's clinical activity index (CAI) was applied to assess UC activity and treatment efficacy. Following an initial 14 days of remission induction therapy with CsA (2mg/kg body weight/day, iv) or Tacrolimus (0.05-0.15mg/kg body weight/day), patients who achieved a CAI score of 3 or better were followed for 12 months. During the 12 months follow-up time, maintenance rate of remission was monitored by using the Kaplan-Meier graphs for survival analyses. RESULTS: In the CsA group, the average CAI scores before and after the initial two weeks of treatment were 13.1 ± 2.92 and 5.6 ± 3.35, respectively (P<0.0001). The corresponding CAI scores in the Tacrolimus group were 9.75 ± 3.27 and 5.0±3.84, respectively (P<0.01). The clinical remission rates (CAI = 3 or better) after the initial two weeks of treatment were 30.0% (24 of 80 patients) in the CsA group and 45.4% (15 of 33 patients) in the Tacrolimus group, the difference was not statistically significant (P=0.11). Further, response rates (a decrease in CAI by at least 4 points) were 77.5% (62 of 80 patients) in the CsA group and 69.7% (23 of 33 patients) in the Tacrolimus group. Again, the difference did not reach significance level (P= 0.38). Likewise, the rates of remission maintenance at 12 months were 35.2% in the CsA group and 33.7% in the Tacrolimus group. The difference did not reach significance level (P= 0.26). CONCLUSIONS: In this study involving 113 patients with UC of corticosteroid refractory background, Tacrolimus and CsA showed similar efficacy both in the rate of remission induction and maintenance of remission.