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New drug offers hope for rheumatoid arthritis

Orencia reduced pain and swelling among patients in Stanford study

Reuters

Updated: 7:47 a.m. ET Sept. 15, 2005

NEW YORK - For rheumatoid arthritis 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, made by Bristol-Myers Squibb, is the first of a new class of

drugs for the condition. On Sept. 6, an advisory panel to the Food

and Drug Administration unanimously agreed that the benefits of

Orencia outweigh the risks and recommended that it be approved for

marketing.

Dr. Mark Genovese of Stanford University Medical Center and

associates in the United States and France randomly assigned 258

patients with acute rheumatoid arthritis who had failed anti-TNF

therapy to Orencia and 133 similar patients to a 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 rheumatoid arthritis

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.

Copyright 2005 Reuters Limited. All rights reserved. Republication or

redistribution of Reuters content is expressly prohibited without the

prior written consent of Reuters.



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