Mycophenolate mofetil: lack of efficacy in chronic active inflammatory bowel disease
Article first published online: 24 DEC 2001
Alimentary Pharmacology & Therapeutics
Volume 14, Issue 2, pages 171–176, February 2000
How to Cite
Fellermann, Steffen, Stein, Raedler, Hämling, Ludwig, Loeschke and Stange (2000), Mycophenolate mofetil: lack of efficacy in chronic active inflammatory bowel disease. Alimentary Pharmacology & Therapeutics, 14: 171–176. doi: 10.1046/j.1365-2036.2000.00695.x
- Issue published online: 24 DEC 2001
- Article first published online: 24 DEC 2001
Mycophenolate mofetil (MMF) is a new immunosuppressant with pharmacodynamic properties comparable to azathioprine. Recent reports found MMF to be effective in inflammatory bowel disease (IBD).
An open-label prospective and uncontrolled multicentre 6 month trial of MMF in combination with steroids was conducted in 24 chronic active IBD patients. A daily steroid demand of ≥ 10 mg prednisone in the preceding 2 months and a Crohn’s disease activity index (CDAI) > 150, or moderate to severe activity according to Truelove, served as criteria 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 mg/day was maintained during months 4–6. The primary end-point was induction and maintenance of remission.
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 months. Depression and migraine necessitated drug withdrawal in two patients.
In conclusion, MMF 2 g/day was unable to induce and maintain remission for a period of 6 months in 23 of 24 chronic active IBD patients. Further controlled investigations are required in view of recent conflicting reports.