FDA Expands Abatacept Indication to Patients Aged ≥2 Years with Psoriatic Arthritis

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved a supplemental Biologics Licensing Application (sBLA) of abatacept (Orencia) for the treatment of patients aged ≥2 years with active psoriatic arthritis (PsA).

Juvenile PsA (JPsA) is estimated to affect as many as 5% of pediatric patients with juvenile idiopathic arthritis (JIA) and can cause permanent joint damage, disability, and issues with both growth and chronic arthritis. The condition presents similarly to adult PsA regarding its clinical features, such as the presence of psoriasis and inflammation in the joints.

“Children living with psoriatic arthritis can experience a number of challenging symptoms including swollen and painful joints,” said Steven Taylor, president and CEO, Arthritis Foundation, in a 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 health care professionals.”

The drug, which was originally approved in 2005 for moderate to severe rheumatoid arthritis (RA), obtained approval for adult patients with active PsA in 2017. The expanded approval was based on studies demonstrating efficacy in pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA), adults with PsA, pharmacokinetic data from adults with RA, and safety data from studies in pediatric patients using the subcutaneous formulation of abatacept.

Results revealed drug concentrations in the blood prior to administration of the next dose were similar between adults with PsA and pediatric patients with JIA with active polyarthritis. Therefore, pharmacokinetic exposure is likely comparable between adults and pediatric patients with PsA.

The most common adverse events reported in adult patients with RA receiving abatacept were headache, nausea, nasopharyngitis, and upper respiratory tract infection. Events observed in ≥5% of patients with pJIA were abdominal pain, diarrhea, cough, and pyrexia. Adverse events were generally comparable regarding type and frequency among pediatric patients with pJIA and adult patients with PsA or RA.

“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, US Immunology, Bristol Myers Squibb, in a statement. “This important milestone represents the latest advance in Orencia’s 18-year legacy in arthritis, reinforcing BMS’ commitment to combatting immune-mediated diseases and helping to improve the lives of patients with chronic diseases.”