For Release at 5:30 PM PT, Sunday Nov. 11, 2001

For More Information, ContactTammy Cussimanio (404) 633-3777 until Nov. 7(415) 905-1005 Nov. 10 - Nov. 15[email protected]

Another treatment option for rheumatoid arthritis sufferers

People with rheumatoid arthritis who are already taking methotrexate may have further improvement in arthritis control with the addition of a new injectable treatment called adalimumab, according to research presented at the American College of Rheumatology Annual Scientific Meeting Nov. 10 - 15 in San Francisco, California.

Tumor necrosis factor (TNF), a natural protein released from immune cells, is one of the critical molecules produced in excess in the joints of patients with rheumatoid arthritis. The over production of TNF in the body can lead to joint inflammation and destruction. In order to reduce the level of TNF in joints of rheumatoid arthritis patients, an antibody (a naturally occurring protein that fights inflammation) was developed. This fully human anti-TNF antibody, adalimumab, selectively binds up the excessive circulating TNF and removes it from the body.

Adalimumab was evaluated in 271 patients who had an inadequate response to methotrexate. The study drug was given by a subcutaneous injection every second week for a period of 24 in combination with methotrexate. Several doses were examined, and a placebo injection was included to reduce bias on the part of the patient and physician.

The results demonstrated significant improvement in the majority (65.7%) of patients with 53.7% of the patients exhibiting an extremely good response according to standard RA evaluation criteria. Adalimumab was well tolerated and appeared safe in the patient population examined.

"The relatively large number of patients that substantially improved with adalimumab despite the previous use of methotrexate, suggests a viable treatment regimen for RA," said Edward Keystone, MD, Professor of Medicine, University of Toronto and an investigator in the study. "The method of administration i.e., a subcutaneous injection once every 2 weeks, makes adalimumab easier to use than current biological therapies that antagonize the activity of TNF. The fully human nature of adalimumab is expected to result in fewer side-effects and sustained benefit for the patient."

The American College of Rheumatology is the professional organization for rheumatologists and health professionals who share a dedication to healing, preventing disability and curing arthritis and related rheumatic and musculoskeletal diseases. For more information on the ACR's annual meeting, see http://www.rheumatology.org.

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