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P293. Risk of malignancies in a single center cohort of IBD-patients treated with immunosuppressives and anti-TNF-antibodies

A. Steinborn1, F. Beigel1, S. Breiteneicher1, K. Van Steen2, B. Göke1, F. Schnitzler1, S. Brand1, M. Weidinger1, T. Ochsenkühn1, J. Seiderer1

1IBD center, Munich, Germany; 2System and Modeling Unit, Montefiore Institute, Liège, Belgium

Aim: In clinical practice, maintenance therapy of patients with inflammatory bowel disease (IBD) with immunosuppressive agents (IS) or Anti-TNF-antibodies still faces concerns regarding the risk of neoplasia. We therefore initiated a retrospective safety analysis of German IBD patients treated at our IBD-center during an observation period of 8 years.

Methods: Safety data from so far 570 IBD patients including 71% of patients with Crohn's disease (CD) and 29% of patients with ulcerative colitis (UC) treated with immunosuppressive agents or Anti-TNF-antibodies between 2002 and 2010 were included into the study. Overall, 260 patients were treated with immunosuppressive agents (azathioprine, 6-mercaptopurine, thio-guanine) only and were never exposed to Anti-TNF-antibodies (study group 1); n = 310 patients were exposed to Anti-TNF-antibodies (infliximab, adalimumab) with no, previous or ongoing history of immunosuppressive treatment (study group 2). Data were analyzed for the incidence of solid neoplasias and lymphomas.

Results: Overall, we observed 12 neoplasias in 11 of 260 patients (4.6%) in study group 1 (IS only) as compared to 6 neoplasias in 6 of 310 patients (1.9%) in study group 2 (TNF±IS), p = 0.09. Five of these 6 patients had previously or ongoing been exposed to immunosuppressive drugs. Analyzing the duration of IS in both groups, we found no difference: The median duration of IS use was 15 months (0–205 months) in group 1 and 11 months (0–240 months) in group 2. Patients with malignomas had a median duration of IS of 43.5 months (2–205 months) in group 1 and 50 months (38–78 months) in group 2. Interestingly, 13 of 18 patients with neoplasias were over the age of 50.

Conclusion: Our data raises serious concerns about the long-term safety of immunosuppressive treatment in IBD patients. Further analysis of our cohort will identify possible risk factors for the development of malignancies.