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

Aliment Pharmacol Ther. 2000 Feb;14(2):171-6. doi: 10.1046/j.1365-2036.2000.00695.x.

Abstract

Background: 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).

Methods: 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.

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 months. Depression and migraine necessitated drug withdrawal in two patients.

Conclusion: 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Colitis, Ulcerative / blood
  • Colitis, Ulcerative / drug therapy
  • Crohn Disease / blood
  • Crohn Disease / drug therapy
  • Female
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Inflammatory Bowel Diseases / drug therapy*
  • Male
  • Middle Aged
  • Mycophenolic Acid / adverse effects
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / therapeutic use
  • Prednisone / therapeutic use*
  • Time Factors

Substances

  • Immunosuppressive Agents
  • Mycophenolic Acid
  • Prednisone