ROCKVILLE, MD. — Follow-up study of two biologics approved to treat juvenile idiopathic arthritis has not identified any new safety signals in pediatric patients that have not been previously identified in adults, a Food and Drug Administration official reported at a Dec. 8 committee meeting.
The FDA's Pediatric Advisory Committee heard updates from the agency on postmarketing safety data on abatacept, a selective T-cell costimulation modulator approved to treat JIA in children aged 6 years and older, and adalimumab, a tumor necrosis factor (TNF) blocker approved for treating JIA in children aged 4-17 years.
Abatacept, administered intravenously, is marketed as Orencia by Bristol-Myers Squibb Co. The company is conducting a 10-year pediatric safety study and is required by the FDA to establish a registry of 500 JIA patients who are treated with abatacept. The patients will be monitored for malignancies, other autoimmune diseases, and serious infections for 3 years. Between December 2005 and July 2009, there were seven reports of adverse events in children aged 7-16 years who were treated with abatacept, including one case of multiple sclerosis in a 14-year-old and lymphoma in a 16-year-old, which are listed in the label.
Adalimumab, administered subcutaneously, is marketed as Humira by Abbott Laboratories. Postmarketing requirements include conducting a 10-year safety study of the drug in 800 JIA patients aged 4-17 years.
In pediatric patients treated for at least 3 years, adverse events were similar in frequency and type to those reported in adults. But rates of hypersensitivity reactions and development of antibodies to adalimumab were higher among pediatric patients.
In August, the FDA reported an ongoing safety review, which suggested that pediatric patients who were treated with TNF blockers were at increased risk for lymphomas and other malignancies, including types rarely seen in children. A statement on this risk was added to the labels of all TNF blockers.
Since approval, 109 serious adverse events were reported in pediatric patients who were treated with adalimumab, of which 37 were cases of exposure in utero. There were two malignancies (lymphomas reported in a 16-year-old and a 10-year-old). Both patients had been on long-term treatment with other immunosuppressants, including other products associated with an increased malignancy risk.