FDA Approves Drug for Active Psoriatic Arthritis

The FDA has approved Bristol-Myers Squibb’s abatacept (Orencia) in both intravenous (IV) and subcutaneous (SC) injections forms for the treatment of active Psoriatic Arthritis (PsA) in adults. The approval is the third autoimmune disease indication for Orencia.

Orencia inhibits T-cell activation, which is involved in the pathogenesis of PsA and contributes to inflammation.

The FDA made its decision after Orencia demonstrated its efficacy and safety in 2 randomized, double-blind, placebo-controlled clinical trials that included 594 adult patients with disease duration of more than 7 years.

Both IV and SC formulations of Orencia reduced disease activity in TNF-naïve patients and exposed patients with high disease activity, high tender and swollen joints, and a disease duration of more than 7 years. Patients treated with Orencia 10 mg/kg IV or 125 mg SC exhibited a higher disease response compared with those taking a placebo (47.5% versus 19% and 39.4% versus 22.3%, respectively).

Concurrent therapy with a TNF antagonist is not recommended due to higher risk of infections, as demonstrated in patients treated with both Orencia and TNF antagonist therapy compared with patients treated with only TNF antagonists in the trial.

Most common adverse events reported in the trials include headache, upper respiratory tract infection, nasopharyngitis, and nausea.

Orencia is also indicated for the treatment of Adult Rheumatoid Arthritis and Juvenile Idiopathic Arthritis.

Reference

Bristol-Myers Squibb’s Orencia (abatacept) receives FDA approvals for treatment of active Psoriatic Arthritis (PsA) in adults [news release]. New Jersey. https://news.bms.com/press-release/rd-news/bristol-myers-squibbs-orencia-abatacept-receives-fda-approval-treatment-active. Accessed July 6, 2017.