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P304. Cyclosporine or infliximab as rescue therapy in severe refractory ulcerative colitis: Early and long-term data from a retrospective observational study

F. Mocciaro1, S. Renna2, A. Orlando3, G. Rizzuto2, E. Sinagra4, E. Orlando5, M. Cottone6

1V Cervello Hospital, Palermo, Italy; 2Palermo University, Villa Sofia‑V. Cervello Hospital/Department of Medicine, Palermo, Italy; 3V Cervello Hospital, Istituto di Medicina Generale e Pneumologia Reparto di Medicina Interna, Palermo, Italy; 4V Cervello Hospital, Palermo University/Department of Medicine Pneumology and Physiology of Nutrition, Palermo, Italy; 5Palermo University, Italy; 6V Cervello Hospital, Instituto di Medicina Generale e Pneumologia, Palermo, Italy

Background: Acute severe ulcerative colitis (UC) is a dangerous clinical condition that requires intensive intravenous (iv) corticosteroid treatment, nevertheless about 30–40% of patients fail to respond. Iv cyclosporine and infliximab are an effective rescue therapy in steroid-refractory UC patients but up to now it is still unclear which is the best therapeutic choice in this setting of patients.

Methods: We reviewed our series of severe (according to Trulove and Witts, and Lichtiger score) steroid-refractory colitis admitted consecutively from 1994 up to today comparing patients treated with cyclosporine (2 mg/kg daily) or infliximab (5 mg/kg). Iv steroid treatment was administered according to the “Oxford regimen”. The main outcome was the colectomy rate at 3 months, 12 months and at the end of the follow-up.

Results: A total of 65 patients were evaluated: 35 in the cyclosporine group and 30 in the infliximab one. The patients' characteristics in the two groups were comparable. After 3 months from the acute episode the colectomy rate was: 28.5% (10/35) in cyclosporine group and 17% (5/30) in infliximab group (p = 0.25). At 12 months the rate of colectomy increased to 48% in cyclosporine group versus 17% in infliximab group (p = 0.007, OR 4.7; 95% CI: 1.47–15.16). The 1–2‑3 years cumulative colectomy rates were 48%, 54%, and 57% in cyclosporine group, and 17%, 23%, and 27% in infliximab group. At the end of the follow-up the colectomy rate was: 60% in cyclosporine group and 30% in infliximab group (p = 0.04, HR 2.2; 95% CI: 1.11–4.86). No difference was observed regarding the risk of re-hospitalization at 12 months (p = 0.3, OR 0.2; 95% CI 0.532–5.805) and during the follow-up (p = 0.7, HR 1.13; 95% CI: 0.48–2.63). High level of C reactive protein (p = 0.04, OR 2.9; 95% CI: 1.18–8.28), extensive disease (p = 0.01, OR 5.5; 95% CI: 1.57–19.01) and no azathioprine treatment after the rescue therapy (p < 0.001, OR 8.7; 95% CI: 2.49–30.12) were related to the risk of colectomy. No differences in terms of side effects were observed between the two groups and no serious adverse events were recorded.

Conclusions: In our experience both cyclosporine and infliximab are effective in avoiding colectomy in severe steroid-refractory UC. During the follow-up the risk of colectomy is higher in those treated with cyclosporine than with infliximab. High level CRP, extensive disease and no azathioprine treatment were related to the risk of colectomy. Both the drugs were equally safe without severe adverse events.