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3 in the anti-TNF-α-exposed versus 0.38/100 patient-years in nonexposed subjects (IR 3.44, P=0.002), without significant difference between anti-TNF-α and azathioprine/6-mercaptopurine/methotrexate (1.3 vs 3.03/100 patient-years, IR 0.43, P=0.1). Predictors of infections in anti-TNF-α-exposed patients were concomitant use of systemic steroids (OR 1.9, P=0.02) or azathioprine (OR 2.6, P=0.01) and a body mass index18.5 at time of infection (OR 2.2, P=0.01). The risk of developing infections during anti-TNF-α therapy remains high, alt