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Mycophenolate mofetil: lack of efficacy in chronic active inflammatory bowel disease
Author(s) -
Klaus Fellermann,
Martín Steffen,
Jürgen M. Stein,
Andreas Raedler,
J Hämling,
D. Ludwig,
K Loeschke,
Eduard F. Stange
Publication year - 2000
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.2000.00695.x
Subject(s) - medicine , prednisone , azathioprine , inflammatory bowel disease , psoriasis , budesonide , mycophenolate , gastroenterology , corticosteroid , crohn's disease , mycophenolic acid , surgery , disease , dermatology , transplantation
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.