Short and long term clinical outcome of infliximab in fulminant ulcerative colitis

Aim: To characterize short and long term clinical outcome of infliximab in fulminant ulcerative colitis. Material and Methods: Patients with severe ulcerative colitis meeting the criteria of fulminant colitis after 3 days ofi.v. glucocorticosteroid treatment were randomized to control or additional induction therapy of i.v. infliximab (5 mg/kg) (0, 2 and 6 weeks), and later on demand therapy. Results: Twenty-six patients with fulminant colitis were equally randomized. At Day 7 ten patients in the control group and none in the infliximab group were in the need of colectomy (p < 0.001). Three of the 7 patients with the need of colectomi at Day 7 in the control group performed surgery. Due to superior effect of infliximab the remaining 10 patients in the control group with and without need of colectomi at Day 7 were of ethical reasons offered to be transformed to infliximab, and 7 of the 10 patients were transformed to infliximab treatment. Thus, 20 patients (13 in the original infliximab group and 7 in the original control group) performed an induction treatment, and thereafter got additional treatment of infliximab on demand. The concomitant treatment was azathioprine (12/20) and 5ASA (13/20). The effect of infliximab at Day 42 was 9 in remission, 8 with response and 3 without response. Additional treatments of infliximab given on demand were 1. 7 doses/year (median) (range 0 5.4). The probability to avoid colectomy was 0.66 with a median observation time of 52 months and a maximal of 91 months. Concomitant use of azathioprine reduced the risk of late colectomy (p < 0.0005) (see figure). Conclusion: We conclude that infliximab and especially in combination with azathioprine is effective in preventing early and late colectomy in fulminant colitis. (Figure presented).