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23 April 2009

Azathioprine therapy in steroid-dependent patients with Crohn disease: results of a 10-year longitudinal follow-up study

Andre Luiz Tavares PintoABDE, Liliana Andrade ChebliABD, Mario Sergio RibeiroCE, Fabio Heleno de Lima PaceDF, Jussara Paixao MoraesBF, Flavio Jose do Amaral Jr.B, Pedro Duarte GaburriADE, Aecio Flavio Meirelles de SouzaCD, Julio Maria Fonseca ChebliACDEG

Med Sci Monit 2009; 15(5): PI19-26 :: ID: 869625


Studies assessing the efficacy of azathioprine in steroid-dependent patients with Crohn's disease are scarce. The aim of this study was to assess the long-term efficacy and safety of azathioprine, and factors associated with sustained response, in steroid-dependent patients with Crohn's disease.
Material and Method
In this prospective, observational study, adult steroid-dependent subjects with Crohn's disease receiving azathioprine therapy were assessed over a 10-year period. Azathioprine dosage was adjusted according to clinical response and occurrence of adverse events. Median treatment duration was 83 months. Steroid therapy was tapered according to protocol.
A total of 106 subjects were included. The proportion of subjects remaining in sustained steroid-free remission at 12, 24, 36, 48, and 60 months was 0.61, 0.73, 0.72, 0.70, and 0.70, respectively. Thereafter, the rate of weaning from steroids decreased gradually, reaching a nadir of 0.41 at 108 months. Median time to complete steroid withdrawal was 6 months. Demographic, azathioprine dose, and disease-related data did not correlate with remission. By multivariate analysis, only decreased mean leukocyte count during follow-up was independently associated with steroid-free remission (P=.001). Subjects who achieved an annual mean leukocyte count <6,000/mm(3) were more likely to sustain steroid-free remission (P=.01). Serious adverse events in response to azathioprine were uncommon.
Azathioprine therapy offers a meaningful option in the management of steroid-dependent Crohn's disease for up to 10 years. A persistent decrease in leukocyte count may provide a surrogate marker of sustained steroid-free response.

Keywords: Prospective Studies, Longitudinal Studies, Follow-Up Studies, Crohn Disease - drug therapy, Azathioprine - therapeutic use, Adrenal Cortex Hormones - therapeutic use

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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750