Orencia Approved for RA Treatment

MARCH 01, 2006
Susan Farley

The FDA has approved abatacept (Orencia), manufactured by Bristol-Myers Squibb Co, for the treatment of rheumatoid arthritis (RA). The phase 3 trial included 3 major double-blind, randomized, placebo-controlled comparison studies: AIM,ATTAIN, and ASSURE. AIM compared abatacept plus methotrexate (MTX) versus MTX alone. ATTAIN compared abatacept plus disease-modifying antirheumatic drugs (DMARDs) versus DMARDs alone.ASSURE compared abatacept plus DMARDs versus placebo. In AIM and ATTAIN, abatacept showed quality improvement in RA signs and symptoms as measured by the American College of Rheumatology criteria. Patients taking abatacept plus MTX achieved a major clinical response, maintaining sustained improvement for 6 months, compared with patients treated with MTX alone. Abatacept is the first approved agent that is safe and effective for RA patients who have not responded well to MTX or tumor necrosis factor (TNF) antagonists. It reduces the signs and symptoms of RA, prompting a major clinical response, slowing structural damage, and improving functioning in adults with moderateto- severe RA who have not responded well to other treatments, such as MTX or TNF antagonists. Abatacept can be used alone or in combination with DMARDs. It should not, however, be used with TNF antagonists, and its use with anakinra is not recommended.

Ms. Farley is a freelance medical writer based in Wakefield, RI.