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* = Presenting author

P153. Tacrolimus treatment in ulcerative colitis – A three center experience

J. Büning1, K. Schmidt1, K. Fellermann1, C. Sina1, J. Emmrich2, D. Barthel3, D. Thomas3, K. Koc3, E.F. Stange3, K.R. Herrlinger3

1University Hospital of Schleswig-Holstein, Lübeck, Germany; 2University Hospital of Rostock, Rostock, Germany; 3Robert-Bosch-Hospital, Stuttgart, Germany

Aims: In steroid-refractory or dependent attacks of ulcerative colitis (UC) tacrolimus has been shown to be beneficial. Its long-term efficacy remains unclear. Furthermore, the need of concomitant immunosuppression is poorly defined. This three center retrospective analysis was carried out to evaluate efficacy and safety of tacrolimus in moderately to severely active UC for induction and maintenance of remission. Primary endpoints were short-term response and colectomy free survival. Secondary outcome data were safety and tolerability.

Methods: Charts of 161 pts. with steroid-dependent or -refractory UC were reviewed. Tacrolimus was administered po at 0.1 mg/kg/d, in rare instances iv at 0.01 mg/kg. 104 out of 161 pts. received triple immunosuppression with purine analogues or methotrexate. Response to treatment at weeks 0, 4 and 12 was evaluated using the Truelove-Witt's index. Patients were visited in the follow-up on a regular outpatient basis.

Results: Tacrolimus treatment was started in median 4 years after disease onset (range 0–33). Distribution of disease localisation was E3 in 90 (57%), E2 in 44 (27%), E1 in 23 pts. (14%). Median tacrolimus dose was 8 mg/d (range 0.56–21). At baseline 118 pts. (74%) experienced severe and 31 pts. (19%) moderate activitiy. Early proctocolectomy was nessessary in 7 after 4 and additional 12 after 12 weeks. Disease activity dropped to mild activity in 83 and 78 pts. at weeks 4 and 12, respectively. Overall colectomy was performed in 36, 11 and 4 pts. within the first, second and third year. Kaplan Meier analysis revealed a colectomy free survival in our cohort of 65% at one year. Purine analogues delayed the necessarity of proctocolectomy although the overall colectomy rate did not differ beyond 3 years. No serious adverse events occurred.

Conclusions: Experience with tacrolimus in UC on this three center basis confirms the previous findings of its efficacy. It may serve to induce remission and bridge to immunosuppressants with a time lag of action. The role of concomitant immunosuppression additionally to tacrolimus seems to be advantageous in the midterm although the long-term role remains doubtful.