BETHESDA, Maryland—The US Food and Drug Administration (FDA) approved the costimulation blocker Orencia® (abatacept) for treating moderate-to-severe active polyarticular juvenile idiopathic arthritis (JIA) in pediatric patients aged ≥6 years. Abatacept is manufactured by Bristol-Myers Squibb Co, Princeton, NJ.1

"I am very pleased that [abatacept] was approved for JIA," said Kathleen A. Haines, MD, section chief of pediatric immunology at Hackensack University Medical Center, NJ. "Although the current approved armamentarium has an excellent overall success rate, there are always patients for whom these do not work," she told MSKreport.com. "As abatacept has been successful in both biologic naïve as well as those who have failed our other biologic agents, I think it will be of great help in some patients. And, as always, the level of comfort is greater in using a drug that has been studied in children with regard to appropriate dosing and understanding toxicities."
"As abatacept has been successful in both biologic naïve as well as those who have failed our other biologic agents, I think it will be of great help in some patients. And, as always, the level of comfort is greater in using a drug that has been studied in children with regard to appropriate dosing and understanding toxicities."—Kathleen A. Haines, MD.

Abatacept can be used as monotherapy or with methotrexate (MTX) in JIA, but should not be used concomitantly with other biologics.

The AWAKEN (Abatacept Withdrawal study to Assess efficacy and safety in Key Endpoints in juvenile idiopathic arthritis Not responding to current treatment) trial, which led to the FDA approval, involved children who previously had an inadequate response to ≥1 disease-modifying antirheumatic drugs (DMARDs), such as MTX or tumor necrosis factor-α antagonists, and who took abatacept and experienced "meaningful and sustained improvements" through 1 year.

Translating research into practice

For pediatric and adolescent JIA patients who weigh <75 kg, abatacept should be administered as a 30-minute intravenous infusion at a dose of 10 mg/kg specifically calculated based on the patient's body weight at each administration. The dose should not exceed a maximum dose of 1000 mg. Pediatric patients weighing ≥75 kg should be administered abatacept following the adult dosing regimen. Following initial administration, the drug should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter.


Revised adult indication for abatacept

The FDA also has revised the adult indication to remove the requirement that patients must first fail at least 1 DMARD before initiating therapy with abatacept.

Reference

1. US Food and Drug Administration approves Orencia® (abatacept) for the treatment of moderate-to-severe polyarticular juvenile idiopathic arthritis (JIA) in patients six years and older [press release April 8, 2008]. BMS Website. http://newsroom.bms.com/index.php?s=press_releases&item=355.