Made by Bristol-Myers Squibb, Orencia is the first in a new class of drugs for the condition. On Sept. 6, an advisory panel to the Food and Drug Administration unanimously agreed the benefits of Orencia outweigh the risks and recommended the drug receive marketing approval.
Dr. Mark Genovese of Stanford University Medical Center, along with associates in the United States and France, randomly assigned Orencia to 258 patients suffering acute rheumatoid arthritis who had failed anti-TNF therapy. A placebo was given to 133 similar patients. All continued to take their existing anti-rheumatic medication.
According to a report in The New England Journal of Medicine
About 47 percent of Orencia-treated patients reported improvement in physical function, when compared to about 23 percent of the group receiving the placebo.
Orencia was also associated with an increased number of patients achieving greater than 50 percent and 70 percent improvement in the number of tender and swollen joints, 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.
Investigators concluded Orencia is clinically useful and has an acceptable safety profile in patients with rheumatoid arthritis who fail to respond adequately to anti-TNF agents.
The study was supported by Bristol-Myers Squibb and a grant from the National Institutes of Health.
