Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved Orencia (abatacept) injection for the treatment of active psoriatic arthritis (PsA) in adults.  

The approval for the new indication was based on results from two randomized, double-blind, placebo-controlled trials (PsA-I and PsA-II; n=594) evaluating Orencia administered by intravenous (IV) and subcutaneous (SC) routes. Enrolled patients had active disease (≥3 swollen joints and ≥3 tender joints) despite prior therapy with DMARDs, and at least one qualifying psoriatic skin lesion ≥2cm in diameter. The primary endpoint was the proportion of patients achieving ACR20 response at Week 24.

Patients enrolled in the study were allowed to receive concomitant therapy of methotrexate, low-dose corticosteroids and/or NSAIDs. More patients treated with Orencia IV (10mg/kg) or SC (125mg) achieved ACR20 response at Week 24 compared to placebo (47.5% vs. 19.0% and 39.4% vs. 22.3%, respectively, P<0.05). A greater response to Orencia was observed regardless of prior anti-TNF treatment and other non-biologic DMARD therapy. At Week 24, patients also experienced improvements in enthesitis and dactylitis with Orencia IV and SC.

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The safety profile for Orencia in PsA-I and PsA-II was similar to the profile seen for rheumatoid arthritis (RA). The most common adverse reactions were headache, nasopharyngitis, upper respiratory tract infection, and nausea.

Orencia, a selective costimulation modulator, is already approved to reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in patients with moderately-to-severely active RA; it may be used alone or with DMARDS other than TNF antagonists. It is also indicated to reduce signs/symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients ≥2 years of age; it may be used alone or with methotrexate.

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