Intravenous cyclosporine versus intravenous corticosteroids as single therapy for severe attacks of ulcerative colitis.
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.
D'Haens
G
G
Department of Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium. geert.dhaens@uz.kuleuven.ac.be
Lemmens
L
L
Geboes
K
K
Vandeputte
L
L
Van Acker
F
F
Mortelmans
L
L
Peeters
M
M
Vermeire
S
S
Penninckx
F
F
Nevens
F
F
Hiele
M
M
Rutgeerts
P
P
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
D007166:Immunosuppressive Agents; D016572:Cyclosporine; D008775:Methylprednisolone