Abstract
malignancies was similar among all 3 exposure cohorts each with an event rate of 0.09 per 100 PY. All patients had prior exposure to IM (1 azathioprine [AZA], 6 6-mercaptopurine [6-MP], and 2 methotrexate [MTX]). Comparisons between DEVELOP and SEER data yielded a SIR of 4.96 (95%CI 1.35, 12.69) for IFX exposed patients, 4.77 (95%CI 1.30, 12.20) for anti-TNF exposed patients and 5.09 (95%CI: 1.05, 14.86) for non-biologic therapies. Among those who were also exposed to immunomodulators, an increase SIR was observed: IFX (n = 1973) (SIR 5.98; 95%CI (1.63, 15.31), anti-TNF (n = 2042) (SIR 5.73; 95%CI: 1.56, 14.67) non-biologics (n = 1171) (SIR 7.12; 95%CI: 1.47, 20.79). Among patients who were not exposed to immunomodulators (n = 1130), no malignant events were reported. Conclusions: Compared to children with IBD treated with other therapies, IFX did not significantly increase the risk of malignancies. Patients who were exposed to immunomodulators had a higher incidence of malignancy and higher SIR rates than those not exposed to immunomodulators.
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