New drug may treat RA when others fail

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For Rheumatoid Arthritis (RA) sufferers who do not get adequate relief from so-called TNF-inhibitors such as etanercept or infliximab, a new drug called Orencia may provide significant clinical and functional benefits, according to a study published this week.

Orencia (abatacept;Bristol-Myers Squibb) is the first of a new class of drugs for RA. On September 6, an advisory panel to the US Food and Drug Administration unanimously agreed that the benefits of Orencia outweigh the risks and recommended that it be approved for marketing.

Dr. Mark C. Genovese, from Stanford University Medical Center in California, and associates in the US and France randomly assigned 258 patients with acute RA who had failed anti-TNF therapy to Orencia and 133 similar patients to placebo. All patients continued to take their existing antirheumatic medication.

According to a report in The New England Journal of Medicine, at 6 months, more patients in the Orencia (50 percent) than in the placebo group (19 percent) had achieved “ACR 20 improvement”—that is a decrease of at least 20 percent in the number of both tender and swollen joints. Marked improvement was noted from day 15 of treatment onward.

Moreover, about 47 percent of Orencia-treated patients reported improvement in physical function compared with only about 23 percent of placebo-treated patients.

Orencia was also associated with significantly greater numbers of patients achieving ACR50 and ACR70 responses (greater than 50 percent and 70 percent improvement in the number of tender and swollen joints, respectively),higher rates of remission, and more improvement in quality of life measures.

The incidence of infections was slightly higher in the Orencia group (37 percent versus 32 percent), but rates of serious infections and other adverse events were low and similar in the two groups. Moreover, Orencia did not appear to increase the incidence of autoimmune antibodies.

The investigators conclude that Orencia is clinically useful and has an acceptable safety profile in patients with RA who fail to respond adequately to anti-TNF agents.

This study was supported by Bristol-Myers Squibb and a grant from the National Institutes of Health.

SOURCE: New England Journal of Medicine, September 15, 2005. 

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