We compared the frequency of malignancies in 207 multiple sclerosis pa
tients (mean age 35.75 years, SD 10.60) who took 2.0 mg/kg azathioprin
e daily (mean duration 4.16 years; SD 2.38) and in 247 nontreated pati
ents (mean age 35.44 years; SD 11.94). Five malignancies were diagnose
d 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 d
eveloping a tumor was 0.85.