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NEUROLOGY 1993;43:831
© 1993 American Academy of Neurology

Long-term safety of azathioprine therapy in multiple sclerosis

M. P. Amato, MD, G. Pracucci, MD, G. Ponziani, MD, G. Siracusa, MD, L. Fratiglioni, MD and L. Amaducci, MD

Department of Neurology, University of Florence, Italy.

We compared the frequency of malignancies in 207 multiple sclerosis patients (mean age 35.75 years, SD 10.60) who took 2.0 mg/kg azathioprine daily (mean duration 4.16 years; SD 2.38) and in 247 nontreat-ed patients (mean age 35.44 years; SD 11.94). Five malignancies were diagnosed in the azathioprine group compared with seven in the control group. The age-adjusted occurrence rate was 3.62/1,000 person-years (95% CI, 1.17 to 8.43) in the treated and 4.24/1,000 person-years (95% CI, 1.70 to 8.73) in the nontreated group; the age-adjusted relative risk of developing a tumor was 0.85.

Address correspondence and reprint requests to Dr. Maria Pia Amato, Department of Neurology, University of Florence, Viale Morgagni, 85, 50134 Florence, Italy.

Received April 24, 1992. Accepted for publication in final form August 4, 1992.




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