The researchers investigated the effects of intravenous (IV) cyclosporine as single IV therapy for severe ulcerative colitis and compared these with the response to glucocorticosteroids.
They reported their findings in the May issue of Gastroenterology.
30 patients with a severe attack of ulcerative colitis were randomized to treatment with IV cyclosporine, 4-mg/kg/dayor with methylprednisolone, 40 mg/day, in the 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.
The endpoints measured were clinical improvement, discharge from the hospital, and remission up to 12 months after intravenous therapy.
The group found that after 8 days, 8 of 15 patients (53%) who received methylprednisolone had a response to therapy.
|UC remission at 12 months after treatment:|
9 out of 14 (64%) who received cyclosporine demonstrated a response.
In non-responders, 3 out of 7 methylprednisolone patients and 1 out of 3 cyclosporine patients improved when both treatments were combined.
No serious drug-related toxicity was observed with either treatment.
At 12 months, 7 out of 9 patients (78%) initially controlled with cyclosporine maintained their remission versus 3 out of 8 (37%) initially treated with methylprednisolone. No clinically significant decrease of renal function was observed.
Researcher Geert D'Haens, of the University Hospital Gasthuisberg, concluded on behalf of the team, "Cyclosporine monotherapy is an effective and safe alternative to glucocorticosteroids in patients with severe attacks of ulcerative colitis."