Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis

Background & Aims: Cyclosporine has been effective in patients with steroid -refractory attacks of ulcerative colitis (UC). We investigated the effects of intravenous (IV) cyclosporine as single IV therapy (without glucocortic osteroids) for severe UC and compared these with the response to glucocorti costeroids. Methods: Patients with a severe attach of UC were randomized to treatment with IV cyclosporine, 4 mg hg(-1) day(-1), or with methylprednis olone, 40 mg/day, in a randomized, doubleblind, controlled trial. After 8 d ays, patients who had a response received the same medication orally in com bination with azathioprine. Patients were followed up clinically, endoscopi cally, and by scintigraphy. Renal function was assessed using urinary inuli n clearances. Endpoints were clinical improvement, discharge from the hospi tal, and remission up to 12 months after intravenous therapy. Results: Thir ty patients were included. After 8 days, 8 of 15 patients (53%) who receive d methylprednisolone had a response to therapy vs, 9 of 14 (64%) receiving cyclosporine. In nonresponders, 3 of 7 methylprednisolone patients and 1 of 3 cyclosporine patients improved when both treatments were combined. No se rious drug-related toxicity was observed with either treatment. At 12 month s, 7 of 9 patients (78%) initially controlled with cyclosporine maintained their remission vs. 3 of 8 (37%) initially treated with methylprednisolone. No clinically significant decrease of renal function was observed. Conclus ions: Cyclosporine monotherapy is an effective and safe alternative to gluc ocorticosteroids in patients with severe attacks of UC.