FDA Approves Expanded Indication for Abatacept to Treat Juvenile Psoriatic Arthritis

The FDA has approved a supplemental Biologics Licensing Application (sBLA) to expand the indication of abatacept (Orencia; Bristol Myers Squibb) for the treatment of juvenile psoriatic arthritis (JPsA) in patients aged 2 to 17 years.

Image credit: Vitalii Vodolazskyi | stock.adobe.com

The expanded indication approval was based on safety data from clinical studies that evaluated abatacept in pediatric patients 2 to 17 years of age with polyarticular juvenile idiopathic arthritis (pJIA), as well as safety data from clinical studies analyzing the subcutaneous formulation of the drug for patients with pJIA aged 2 to 17 years.

The FDA initially approved abatacept in 2005 for the treatment of moderate to severe rheumatoid arthritis (RA). The drug was also approved in 2017 for adult patients with active psoriatic arthritis (PsA).

Abatacept is now indicated for the treatment of adult patients with moderately to severely active RA, patients aged 2 to 17 years with moderately to severely active pJIA, and active PsA. Abatacept can also be used in combination with a calcineurin inhibitor and methotrexate for the treatment of acute graft-versus-host disease in adults and pediatric patients aged 2 years and older who are undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated-donor.

The observed concentration of abatacept in the blood immediately prior to administration of the next subsequent dose was similar between adults with PsA and pediatric patients with JIA with active polyarthritis. Further, pharmacokinetic exposure is expected to be comparable between adults and children with PsA, according to the investigators.

“The FDA’s approval of expanding [abatacept] 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, United States Immunology, Bristol Myers Squibb.

The safety and efficacy of abatacept yet to be established in children under 2 years of age with PsA. Clinical studies of abatacept in adults with RA and pediatric patients with pJIA showed that observed adverse events (AEs) were similar in frequency and type.

The most frequently reported AEs among adults were headache, upper respiratory tract infection, nasopharyngitis, and nausea. Among pediatric patients, the most commonly reported AEs were diarrhea, cough, pyrexia, and abdominal pain. Although less common, the most frequent serious AEs were anemia, reduction in CD4 lymphocytes, hypertension, pyrexia, CMV reactivation or infection, pneumonia, epistaxis, acute kidney injury, and hypermagnesemia.

“Children living with psoriatic arthritis can experience a number of challenging symptoms, including swollen and painful joints,” said Steven Taylor, president and CEO of the Arthritis Foundation, in a press release. “The FDA’s approval of [abatacept] 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 health care professionals.”

Reference

Bristol Myers Squibb. FDA Expands Approval of BMS' Medicine to Include Pediatric Patients with Psoriatic Arthritis. News release. October 31, 2023. Accessed October 31, 2023. Email.