The analysis showed the reporting rate for U.S. cases of malignancy in children for infliximab was 66 per 100,000 patient years, 4 times the estimated background rate for the general U.S. pediatric population. For lymphomas in children, the reporting rate was 44 per 100,000 patient years, 18 times the background rate. If cases of hepatosplenic T cell lymphoma are excluded from the calculation, the reporting rate for lymphomas with infliximab drops to 22 per 100,000 patient years but still exceeds the background rate by 9 times. For etanercept, the reporting rate for U.S. cases of malignancy in children was 22 per 100,000 patient years and approximated the background rate. However, for lymphomas, the reporting rate with etanercept was 11 per 100,000 patient years, 5 times the background rate for lymphomas in children.
The team concludes that the risk of malignancy should be considered prior to initiating TNF blockers in children, particularly as some of the reported cases involved types of cancers not commonly seen in children and that are usually associated with immunosuppression. Further, they suggest that the true incidence rate for these events in the pediatric population may be even higher due to substantial under-reporting to FDA's MedWatch program. Another concern is that the latency period of malignancy indicates there may be an extensive interval between the onset of TNF blocker treatment and the
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