FDA Approves sBLA for Abatacept in the Treatment of Juvenile Psoriatic Arthritis

The FDA has approved the supplemental Biologics Licensing Application (sBLA) for abatacept (Orencia; Bristol Myers Squibb) for the treatment of juvenile psoriatic arthritis (JPsA) in patients aged 2 to 17 years. The approval is supported by safety data from clinical studies assessing abatacept in pediatric patients aged 2 to 17 years with polyarticular juvenile idiopathic arthritis (pJIA) and safety data from clinical studies using the subcutaneous formulation for pediatric patients with pJIA aged 2 to 17 years.

Abatacept was initially approved by the FDA in 2005 for moderate to severe rheumatoid arthritis (RA) and in 2017 for adults with active psoriatic arthritis (PsA). It is currently indicated for the treatment of adult patients with moderate to severe active RA, patients aged 2 to 17 years with moderate to severe active pJIA, and active PsA. Further, abatacept can be used in combination with a calcineurin inhibitor and methotrexate to treat acute graft versus host disease in both adult 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 concentrations of abatacept in the blood immediately before the administration of the next dose—or trough concentrations—were comparable between adults with PsA and pediatric patients with JIA with active polyarthritis. In addition, pharmacokinetic exposure is anticipated to be comparable between adults and children with PsA. The safety and efficacy of abatacept has not yet been established in children under 2 years of age with PsA.

“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.

In clinical studies evaluating abatacept in adult patients with RA and pediatric patients with pJIA, the adverse events (AEs) reported were similar in frequency and type. The most frequent AEs reported by adult patients were headache, upper respiratory tract infection, nasopharyngitis, and nausea. In pediatric patients, the most common 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. “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.