資料來源：https://www.businesswire.com/news/home/20170706005249/en/Bristol-Myers-Squibb%E2%80%99s-ORENCIA-abatacept-Receives-FDA-Approval

Bristol-Myers Squibb Company announced yesterday the U.S. Food and Drug Administration (FDA) has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis (PsA), a chronic, inflammatory disease that can affect both the skin and musculoskeletal system. ORENCIA is approved and available in both intravenous and subcutaneous (SC) injection formulations. ORENCIA should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic Rheumatoid Arthritis (RA) therapy, such as anakinra. This approval marks the third autoimmune disease indication for ORENCIA.

“This approval underscores the efficacy of ORENCIA in adult patients with active Psoriatic Arthritis, who have been in need of new treatments,” said Brian J. Gavin, Vice President, ORENCIA Development Lead at Bristol-Myers Squibb. “Helping to advance clinical understanding of autoimmune conditions is a key focus of our immunoscience research, and we’re proud to introduce ORENCIA, a selective T-cell co-stimulation modulator, as an additional treatment option for PsA.”

The co-stimulation blockade of ORENCIA inhibits T-cell activation and the resulting cascade of events that contribute to inflammation. T-cell activation is involved in the pathogenesis of PsA.

Psoriatic Arthritis can cause joint pain, stiffness and reduced range of motion, potentially affecting the ability to do everyday activities, such as getting dressed and tying shoes. In PsA, the immune system attacks healthy joints and skin.

“Psoriatic Arthritis takes a toll on patients and families over time,” said Randy Beranek, president and CEO, National Psoriasis Foundation. “We welcome the introduction of an additional treatment option for adults with active Psoriatic Arthritis, because we believe advancements, along with further research, education and support services, are critical to helping improve the lives of those impacted.”

The approval was based on results from two randomized, double-blind, placebo-controlled trials in which ORENCIA improved (or reduced) disease activity in both TNF-naive and exposed patients with high disease activity, high tender and swollen joints, and a disease duration of more than seven years.

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic, inflammatory disease that can affect both the skin and musculoskeletal system. PsA can cause joint pain, stiffness and reduced range of motion. Most commonly affecting the distal joints (those closest to the nail) of the fingers or toes, as well as the wrists, knees, ankles and lower back, the disease usually appears between the ages of 30 to 50, but can begin as early as childhood. Men and women are equally at risk. Early recognition, diagnosis and treatment of Psoriatic Arthritis are critical to helping relieve pain and inflammation.