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Gut. May 1999; 44(5): 625–628.
PMCID: PMC1727513
Randomised trial of mycophenolate mofetil versus azathioprine for treatment of chronic active Crohn's disease
M Neurath, R Wanitschke, M Peters, F Krummenauer, B zum, and J Schlaak
I. Department of Medicine, University of Mainz, Langenbeckstrasse 1, 55101 Mainz, Germany.
BACKGROUND—Crohn's disease is a chronic inflammatory disease of the alimentary tract. Azathioprine is an effective agent in the management of chronic active Crohn's disease leading to long term remission of disease activity. Such treatment leads to limited efficacy or side effects in a small subset of patients.
AIMS—To compare efficacy and side effects of treatment with azathioprine plus corticosteroids versus mycophenolate mofetil (MMF) plus corticosteroids in patients with chronic active Crohn's disease.
METHODS—Seventy patients with chronic active Crohn's disease (Crohn's disease activity index (CDAI) greater than 150) were randomised for treatment with azathioprine/cortisone or MMF/cortisone. Corticosteroid dosage was tapered according to a standard protocol. Disease activity was monitored by clinical scores after one, two, three, and six months.
RESULTS—Treatment of patients with moderately active (CDAI 150-300) Crohn's disease with MMF/cortisone led to a significant reduction in clinical activity scores comparable to treatment with azathioprine/cortisone. Treatment of patients with highly active Crohn's disease (CDAI greater than 300) with MMF/cortisone caused significant suppression of clinical activity earlier than azathioprine/cortisone treatment. Treatment with MMF/cortisone was associated with few adverse effects.
CONCLUSION—Treatment of chronic active Crohn's disease with MMF plus cortisone appears to be effective and well tolerated and should be considered in patients allergic to azathioprine or in whom azathioprine has failed.

Keywords: mycophenolate mofetil; azathioprine; Crohn's disease
Figure 1
Figure 1
Progress of patients during the randomised trial.27
Figure 2
Figure 2
CDAI scores of all Crohn's patients before and after treatment with MMF or azathioprine. CDAI scores were determined at indicated time points and are shown in Box/Whisker plots. Points (circles and asterisks) outside the plots represent values outside (more ...)
Figure 3
Figure 3
CDAI scores of Crohn's patients with initially moderate activity (CDAI 150-300). CDAI scores were determined at indicated time points and are shown in Box/Whisker plots. Points (circles) outside the plots represent values outside the 2 (3) SD interval.
(more ...)
Figure 4
Figure 4
CDAI scores of Crohn's patients with initially high activity (CDAI >300). CDAI scores were determined at indicated time points and are shown in Box/Whisker plots. Points (asterisks and circles) outside the plots represent values outside the 2 (more ...)
Figure 5
Figure 5
Cumulative percentage of patients entering remission at indicated time points during the six month observation period.
Articles from Gut are provided here courtesy of
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