FDA Approves Abatacept for Pediatric Patients With Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved an expanded indication for abatacept (Orencia) for treatment of psoriatic arthritis (PsA) in pediatric patients 2 years of age and older.

Juvenile psoriatic arthritis (JPsA) is a form of juvenile idiopathic arthritis (JIA). It is a rare condition, and it is estimated that as many as 5% of children with JIA have JPsA.

"The FDA's approval of expanding Orencia's indication adds a much-needed treatment option for children with JPsA, a rare, potentially serious condition characterized by chronic inflammation and joint damage," said Carlos Dortrait, senior vice president of US immunology at Bristol-Myers Squibb (BMS) in a statement. BMS is the manufacturer of abatacept.

Abatacept was first approved in 2005 for the treatment of moderate to severe rheumatoid arthritis and was approved for treating active PsA in adults in 2017. In 2008, the drug was the first intravenous biologic approved for patients 6 years old and older to treat moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). In 2017, a subcutaneous administration option was approved for children 2 years old and older with pJIA, according to a BMS press release.

This expanded approval was based on controlled studies of abatacept in adults with PsA; pharmacokinetic data from adults with rheumatoid arthritis, adults with PsA, and children with pJIA; and safety data from clinical studies in patients aged 2 years to 17 years with pJIA.

"Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints," Steven Taylor, president and CEO of the Arthritis Foundation, said in a BMS statement.

"The FDA's approval of Orencia for JPsA in patients 2 years of age and older means another treatment option is available to manage this rare chronic disease, which is exciting news for the arthritis community of young patients, their caregivers, and healthcare professionals."

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Lead image: Bristol Myers Squibb

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Cite this: Lucy Hicks. FDA Approves Abatacept for Pediatric Patients With Psoriatic Arthritis - Medscape - Oct 31, 2023.

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