Cyclosporine or infliximab as rescue therapy in severe 2 refractory ulcerative colitis: Early and long-term data 3 from a retrospective observational study

Introduction: About 30–40% of patients with acute severe ulcerative colitis (UC) fail to respond 23 to intensive intravenous (iv) corticosteroid treatment. Iv cyclosporine and infliximab are an ef- 24 fective rescue therapy in steroid-refractory UC patients but up to now it is still unclear which is Q225 the best therapeutic choice in this setting of patients. 26 Methods: We reviewed our series of severe steroid-refractory colitis admitted consecutively in 27 our referral center since 1994 comparing two historical cohort treated with cyclosporine or 28 infliximab. Iv cyclosporine was administered at the dosage of 2 mg/kg and infliximab at the dos- 29 age of 5 mg/kg. The main outcome was the colectomy rate at 3 months, 12 months and at the 30 end of the follow-up. 31 Results: A total of 65 patients were included: 35 in the cyclosporine group and 30 in the inflix- 32 imab one. After 3 months from the acute episode the colectomy rate was: 28.5% (10/35) in the 33 cyclosporine group and 17% (5/30) in the infliximab group (p=0.25). At 12 months the rate of 34 colectomy increased to 48% in the cyclosporine group versus 17% in the infliximab group 35 (p=0.007, OR 4.7; 95% CI: 1.47–15.16). The 1–2–3 year cumulative colectomy rates were 48%, 36 54%, and 57% in the cyclosporine group, and 17%, 23%, and 27% in the infliximab group. At the 37 end of the follow-up the colectomy rate was: 60% in the cyclosporine group and 30% in the inflix- 38 imab group (p=0.04, HR 2.2; 95% CI: 1.11–4.86). High level of C reactive protein (p=0.04, OR 39 2.9; 95% CI: 1.18–8.28), extensive disease (p=0.01, OR 5.5; 95% CI: 1.57–19.01) and no azathi- 40 oprine treatment after the rescue therapy (pb0.001, OR 8.7; 95% CI: 2.49–30.12) were related 41 to the risk of colectomy.