Mycophenolate mofetil versus azathioprine in patients with chronic active ulcerative colitis: A 12-month pilot study

OBJECTIVE: Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) o f unknown etiology frequently requiring long-term therapy for control of sy mptoms and prevention of relapse. Azathioprine (AZA) has been shown to be e ffective and safe in the treatment of chronic active UC. However, the alter natives to treatment with AZA are limited. Our aim was to compare the effic acy and safety of treatment with mycophenolate mofetil (MMF)/prednisolone v ersus standard immunosuppressive treatment with azathioprine (AZA)/predniso lone in patients with chronic active UC. METHODS: The study was designed as an open comparison of MMF versus AZA. Tw enty-four patients with active UC (Rachmilewitz score greater than or equal to 6 points) were randomly assigned to the MMF (20 mg/kg)/prednisolone or AZA (2 mg/kg)/prednisolone group. The initial prednisolone dosage was 50 mg and was tapered according to a standard protocol. Treatment was scheduled for 1 yr. RESULTS: The rates of remission were higher in the AZA/prednisolone group ( n = 12) than in the MMF/prednisolone group (n = 12) throughout the study. R emission rates were 92% versus 67% after 4 wk, 92% versus 67% after 3 month s, 92% versus 67% after 6 months, 83% vel-sus 78% after 9 months, and 100% versus 88% after 1 yr. The number of patients not requiring steroids was hi gher in the AZA/prednisolone group than in the MMF/prednisolone group. More over, in the AZA/prednisolone group no severe adverse events were recorded, whereas in the MMF/prednisolone group two severe adverse events were obser ved: one patient discontinued MMF after 6 months because of recurrent upper airway infections, and one patient exhibited a bacterial meningitis after 9 months. CONCLUSIONS: Treatment with AZA/prednisolone appears to be more effective a nd safe compared to MMF/prednisolone in patients with chronic active UC. MM F might be an alternative treatment for patients with contraindications to AZA. To further evaluate the effects of MMF in active UC, a placebo-control led double-blinded study appears warranted. (C) 2000 by Am. Cell. of Gastro enterology.