Review of Biologics in Children With Rheumatic Diseases

Shabina Habibi; Athimalaipet V Ramanan


Int J Clin Rheumatol. 2012;7(1):81-93. 

In This Article

Safety of Anti-TNF-α Agents in JIA

Reported adverse effects with anti-TNF-α blockers are generally mild and transient. Local skin reactions/infusion reactions are generally mild and transient. Minor infections are common, usually upper respiratory tract infections, but there is also a higher risk of developing tuberculosis. This risk is higher with the monoclonal antibodies infliximab and adalimumab, as compared with etanercept.[25,26] Autoimmune phenomena such as drug-induced lupus, demyelinating disease, uveitis, psoriasis and inflammatory bowel disease are rare. The risk of malignancies has been reported to be increased in children treated with anti-TNF-α agents. The postmarketing surveillance data on anti-TNF-α agents collected by the FDA reported 48 malignancies developing in children, of which 20 occurred in children with rheumatic conditions.[27] However 88% of these children were also receiving other immunosuppressive drugs, including corticosteroids, azathioprine and methotrexate. Approximately half of the malignancies reported were lymphomas, leukemias, melanoma and other solid tumors were also reported. The FDA has added a boxed warning with regard to the possible increased risk of malignancy, especially lymphomas, in children treated with anti-TNF-α agents. Despite this, a recent summary of worldwide pediatric malignancies in children treated with etanercept did not find an overall increased risk. However the authors acknowledge that it is difficult to assess the actual risk due to the rarity of malignant events, the underlying higher risk of lymphomas and leukemias in children with JIA and the confounding use of other immunosuppressants.[28]


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