BioCentury
ARTICLE | Clinical News

VA researchers recommend delaying use of Enbrel for RA

June 13, 2013 12:44 AM UTC

Researchers at the Department of Veterans Affairs published a study that they said suggests a strategy of first administering a triple therapy of generics to treat adults with active rheumatoid arthritis (RA) before switching to a regimen with once-weekly Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN) and Pfizer Inc. (NYSE:PFE). The researchers said the strategy -- where patients who do not have an adequate response to triple therapy would switch to Enbrel plus methotrexate -- will allow a "substantial percentage" of patients to be treated in a more cost-effective way without adversely affecting clinical outcomes. Amgen said in a statement that based on Enbrel's safety and efficacy, the company is "confident that [the drug] will remain a key tool to treat moderately to severely active rheumatoid arthritis." The VA told BioCentury it would be unable to respond in time for publication to a request for comment regarding whether or not it will change its treatment practices based on the study.

The strategy recommended by the VA researchers is based on data from the double-blind RACAT trial, where initial therapy with once-weekly Enbrel as an add-on to methotrexate was non-inferior to initial therapy with the generics sulfasalazine and hydroxychloroquine as an add-on to methotrexate on the primary endpoint of reducing mean DAS28 score from baseline to week 48. There were also no significant differences between treatment arms on secondary endpoints, including radiographic progression, pain and health-related quality of life. Rates of adverse events were similar, though gastrointestinal disorders occurred more frequently with triple therapy, while infections and skin and subcutaneous disorders occurred more frequently with Enbrel plus methotrexate. The trial enrolled 353 RA patients with active disease despite methotrexate therapy; patients were switched in a blinded fashion at week 24 if they did not have an improvement according to a pre-specified threshold on their initial therapy. The study was published in the New England Journal of Medicine. ...