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P179. Long-term efficacy and safety of cyclosporine as a rescue therapy in acute, steroid-refractory severe ulcerative colitis: Switching to infliximab is more effective than treating with concomitant immunomodulators

T. Molnar1, K. Farkas1, T. Nyari2, Z. Szepes1, F. Nagy1, T. Wittmann1

1First Department of Medicine, University of Szeged, Szeged, Hungary; 2Department of Medical Informatics, University of Szeged, Szeged, Hungary

Introduction: Cyclosporine is highly effective in the first few weeks of rescue therapy; however, most of the responders subsequently undergo colectomy.

Our aim was to assess the short and long-term efficacy and the safety of cyclosporine treatment in our patients with steroid-refractory severe ulcerative colitis (UC) and to evaluate which concomitant immunosuppressive therapy influences the late colectomy rate.

Patients and Methods: 72 (39 females, 33 males; mean age at the diagnosis 31.8 years) steroid-refractory UC patients underwent intravenous cyclosporine treatment for 5 days following oral therapy in case of good initial response. 43.3% of the patients received 5-aminosalycilates (5-ASAs) and the same proportion was on immunomodulators (azathioprine [AZA]/6-mercaptopurine [6-MP]) before the initiation of rescue therapy. The mean follow up after the initiation of cyclosporine therapy was 2.9 years. For evaluating prognostic factors of efficacy, categorical data analyses were conducted on age, gender, smoking status, disease duration, disease extent, 5-ASA used before and AZA/6-MP used after cyclosporine treatment and dose of cyclosporine. P < 0.05 was considered statistically significant.

Results: 79.2% (57/72) of the patients initially responded to intravenous cyclosporine, whereas the other 22.2% underwent early colectomy. Cyclosporine therapy had to be discontinued due to intolerable or severe side effects in 26.4% (19/72) of the patients. Colectomy was performed in 63.2% (12/19) of them. The mortality rate was 0%. Cyclosporine failed and colectomy was performed in 45.5% (26/57) of the responders during the long-term follow up. 17 of the 57 patients, who have lost their response to cyclosporine after 3-month treatment period, received infliximab. Of these, 76.5% (13/17) remained colectomy-free. In AZA/6-MP treated patients colectomy-free rate was 67.6%. Patients who were on 5-ASAs before the initiation of cyclosporine had a lower risk not only for early but for the overall colectomy (p = 0.045, OR: 0.23, 95% CI 0.05–0.97 and p = 0.046, OR: 0.33, 95% CI 0.11–0.98). Neither age, nor gender, nor smoking, nor concurrent use of immunomodulators was associated with lower colectomy risk. However, patients with left sided colitis vs. pancolitis (38.9% vs. 61.1%, p = 0.03) were found to be in association with reduced risk of colectomy. Despite the large number of patients who received AZA/6-MP after the initiation of cyclosporine and avoided colectomy, no statistical difference was shown confirming that concomitant treatment with AZA or 6-MP could reduce the colectomy rate on the follow up.

Discussion: The facts that concurrent immunomodulator use did not decrease colectomy rate and 76.5% of the patients treated with infliximab after the good initial but poor late response to cyclosporine avoided colectomy indicate that the switch from cyclosporine to infliximab after the successful initial response to cyclosporine therapy may be more effective than treatment with concomitant immunomodulator therapy.