Z Gastroenterol 2010; 48 - P253
DOI: 10.1055/s-0030-1263693

Tacrolimus in ulcerative colitis – extended three center experience

KJ Schmidt 1, K Fellermann 1, J Emmrich 2, D Barthel 3, D Thomas 1, H Koc 3, H Lehnert 1, J Büning 1, EF Stange 3, KR Herrlinger 3
  • 1UKSH, Campus Lübeck, MK I, Gastroenterologie, Lübeck, Germany
  • 2Universität Rostock, Klinik für Innere Medizin II, Rostock, Germany
  • 3Robert Bosch-Krankenhaus, Gastroenterologie, Hepatologie und Endokrinologie, Stuttgart, Germany

Aims: In steroid-refractory or dependent attacks of ulcerative colitis (UC) tacrolimus has been shown to be beneficial although its long term efficacy remains unclear. Furthermore, the need of concomitant immunosuppression is ill defined.

Objectives: Aim of this three center retrospective analysis was 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 patiens with steroid-dependent or -refractory UC were reviewed. Tacrolimus was administered po at 0.1mg/kg/d, in some instances iv at 0.01mg/kg. 104 out of 161 patients 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 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 patients (14%). Median tacrolimus dose was 8mg/d (range 0.56–21). At baseline 118 patients (74%) experienced severe and 31 (19%) moderate activitiy. Early proctocolectomy was nessessary in 7 patients after 4 and additional 12 after 12 weeks. Disease activity dropped to mild activity in 83 and 78 patients at weeks 4 and 12, respectively. Overall colectomy was performed in 36, 11 and 4 patients within the first, second and third year. Kaplan Meier analysis revealed a colectomy free survival in the complete cohort of 65% and 28% at one and two years, respectively. Purine analogues delayed the necessarity of proctocolectomy although the overall colectomy rate did not differ beyond 3 years. Adverse events were recorded and will be presented.

Conclusions: Experience with tacrolimus in UC on this three center basis confirms previous findings. It may serve as treatment choice to achieve an operable state or as a 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.