Study Raises Questions about TNF Blockers and the Risk of Malignancy in Children

ScienceDaily—July 29, 2010

The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor a (TNF) blockers, raising concerns of an associated risk and prompting an investigation. Researchers from the FDA set out to identify all reports of malignancy in children using infliximab, etanercept, and adalimumab and their report is published in the August issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.

The FDA has approved 3 TNF blockers for use in children: Etanercept to treat juvenile idiopathic arthritis (JIA); infliximab to treat Crohn's disease; and adalimumab to treat JIA. Data suggest that certain adult populations may be at an increased risk of malignancy with TNF blocker therapy. The immunosuppressive properties of TNF blockers may also increase the risk of malignancy in children, but to what extent is unclear.

The report in Arthritis & Rheumatism is accompanied by an editorial, written by Thomas Lehman, M.D., chief of Pediatric Rheumatology at Hospital for Special Surgery in New York, which points out that while the study raises a key concern, it is important to recognize that 25 of the 48 cases of malignancies occurred in children with inflammatory bowel disease who were also receiving immunosuppressants and thus the study findings are not directly relevant to children with JIA. The editorial also highlights that there is no convincing evidence that the use of TNF blockers in children with JIA is associated with an increased risk of malignancy beyond that due to the disease alone or the disease when treated with methotrexate.

Read the full article at sciencedaily.com.