Mycophenolate mofetil: lack of efficacy in chronic active inflammatory bowel disease

Background: Mycophenolate mofetil (MMF) is a new immunosuppressant with pha rmacodynamic properties comparable to azathioprine. Recent reports found MM F to be effective in inflammatory bowel disease (IBD). Methods: An open-label prospective and uncontrolled multicentre 6 month tri al of MMF in combination with steroids was conducted in 24 chronic active I BD patients. A daily steroid demand of greater than or equal to 10 mg predn isone in the preceding 2 months and a Crohn's disease activity index (CDAI) > 150, or moderate to severe activity according to Truelove, served as cri teria for chronic activity. The treatment consisted of a steroid pulse and tapering protocol in combination with MMF 2 g/day. A prednisone dose of 5 m g/day was maintained during months 4-6. The primary end-point was induction and maintenance of remission. Results: Only 10 of 24 patients had achieved remission after 3 months. All but one Crohn's disease patient had relapsed by the end of the study at 6 m onths. Depression and migraine necessitated drug withdrawal in two patients . Conclusion: In conclusion, MMF 2 g/day was unable to induce and maintain re mission for a period of 6 months in 23 of 24 chronic active IBD patients. F urther controlled investigations are required in view of recent conflicting reports.