New Study Demonstrates ACTEMRA(R) (tocilizumab) Inhibits Progression of Joint Damage in Rheumatoid Arthriti...(eir primary endpoints. The LITHE trial e...),Health

Date:5/9/2008

eir primary endpoints. The LITHE trial evaluating ACTEMRA in RA is an ongoing two-year study and is expected to report complete data evaluating the effects of ACTEMRA on the inhibition of structural joint damage in 2009. ACTEMRA is awaiting approval in the United States and Europe.

ACTEMRA is part of a co-development agreement with Chugai, a Japanese company. In April 2005, ACTEMRA was launched by Chugai in Japan as a therapy for Castleman's disease; in April 2008, ACTEMRA was approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis in Japan.

The serious adverse events reported in ACTEMRA clinical trials were serious infections and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache and hypertension. Increases in liver function tests (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no hepatic injuries or any observed impact on liver function.

About IL-6

IL-6 is a common protein found in all joints in the body and is a natural substance that can raise inflammation. Everyone has IL-6 in their body, but people with RA may have too much. If approved, ACTEMRA will be the first and only medication to specifically target IL-6 inhibition in patients with RA.

About Rheumatoid Arthritis

Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain and movement limitation around joints of the hands, feet, elbows, knees and neck that leads to loss of function. In addition, the systemic symptoms of R
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