title: Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis.
abstract: OBJECTIVE
  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 glucocorticosteroids) for severe UC and compared these with the response to glucocorticosteroids.
  
  
  METHODS
  Patients with a severe attack of UC were randomized to treatment with IV cyclosporine, 4 mg x kg(-1) x day(-1), or with methylprednisolone, 40 mg/day, in a randomized, double-blind, controlled trial. After 8 days, patients who had a response received the same medication orally in combination with azathioprine. Patients were followed up clinically, endoscopically, and by scintigraphy. Renal function was assessed using urinary inulin clearances. Endpoints were clinical improvement, discharge from the hospital, and remission up to 12 months after intravenous therapy.
  
  
  RESULTS
  Thirty patients were included. After 8 days, 8 of 15 patients (53%) who received 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 serious drug-related toxicity was observed with either treatment. At 12 months, 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.
  
  
  CONCLUSIONS
  Cyclosporine monotherapy is an effective and safe alternative to glucocorticosteroids in patients with severe attacks of UC.
authors: Department of Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium. geert.dhaens@uz.kuleuven.ac.be
authors: G
authors: G
authors: D'Haens
authors: L
authors: L
authors: Lemmens
authors: K
authors: K
authors: Geboes
authors: L
authors: L
authors: Vandeputte
authors: F
authors: F
authors: Van Acker
authors: L
authors: L
authors: Mortelmans
authors: M
authors: M
authors: Peeters
authors: S
authors: S
authors: Vermeire
authors: F
authors: F
authors: Penninckx
authors: F
authors: F
authors: Nevens
authors: M
authors: M
authors: Hiele
authors: P
authors: P
authors: Rutgeerts
mesh_terms: D000328:Adult; D000368:Aged; D003082:Colectomy; D003093:Colitis, Ulcerative / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D016099:Endoscopy, Gastrointestinal; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007275:Injections, Intravenous; D007668:Kidney / Q000187:drug effects; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D011877:Radionuclide Imaging
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D008775:Methylprednisolone