Orencia Approved for RA Treatment

The FDA has approved abatacept(Orencia), manufactured by Bristol-MyersSquibb Co, for the treatment of rheumatoidarthritis (RA). The phase 3 trial included3 major double-blind, randomized,placebo-controlled comparison studies:AIM,ATTAIN, and ASSURE. AIM comparedabatacept plus methotrexate (MTX) versusMTX alone. ATTAIN compared abataceptplus disease-modifying antirheumaticdrugs (DMARDs) versusDMARDs alone.ASSURE compared abataceptplus DMARDs versus placebo. In AIMand ATTAIN, abatacept showed qualityimprovement in RA signs and symptomsas measured by the American College ofRheumatology criteria. Patients takingabatacept plus MTX achieved a majorclinical response, maintaining sustainedimprovement for 6 months, comparedwith patients treated with MTX alone.Abatacept is the first approved agent thatis safe and effective for RA patients whohave not responded well to MTX or tumornecrosis factor (TNF) antagonists. Itreduces the signs and symptoms of RA,prompting a major clinical response,slowing structural damage, and improvingfunctioning in adults with moderateto-severe RA who have not respondedwell to other treatments, such as MTX orTNF antagonists. Abatacept can be usedalone or in combination with DMARDs. Itshould not, however, be used with TNFantagonists, and its use with anakinra isnot recommended.

Ms. Farley is a freelance medicalwriter based in Wakefield, RI.