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Roche: New Data On Actemra Shows Benefits In RA May, 2008





Swiss drugmaker Roche Holding AG (RHHBY) said Friday that Actemra can significantly inhibit structural damage to joints in patients with rheumatoid arthritis, a critical measure of effectiveness of an RA treatment.

Actemra also improved the patients' physical function after one year of therapy, leading to a better quality of life.

Results from the LITHE trial showed that a greater proportion of patients treated with Actemra in combination with a commonly used RA drug called methotrexate benefited from a significant inhibition of structural damage during 12 months of therapy, compared to patients treated with MTX alone.

This is critical to patients because damage in the joints caused by the disease leads to the disability and pain associated with RA. Additionally, Actemra improved the patients ability to perform normal daily activities, as assessed by Health Assessment Questionnaire scores.

In the LITHE study, Actemra was generally well tolerated and the overall safety profile after 12 months of treatment was consistent with previously reported 6 month trial data. The outcome of this study is good news for RA patients as presently many either fail to achieve an adequate response or cannot tolerate therapies currently available. New treatment options are needed, particularly those that can target different pathways to bring relief and inhibit joint damage in patients suffering from RA.

"The LITHE data further shows the potential of Actemra as an effective and well tolerated treatment for patients suffering from the debilitating effects of RA" said William M. Burns, CEO Roche Pharmaceuticals Division. "By demonstrating an inhibition of joint damage and improving physical function, Actemra not only positively impacts the disease, but also helps patients to improve the quality of their lives."

The LITHE study is the fifth global phase III trial on Actemra to successfully meet its primary endpoints in patients with moderate to severe RA. First-year data from this two-year trial will be submitted for presentation at upcoming international scientific meetings.

Actemra is the first of a new class of drug with a novel mechanism of action that brings new hope to RA patients. It is a humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody which works by suppressing the activity of IL-6, an important trigger of the inflammatory process. This novel mode of action reduces inflammation of the joints and relieves the systemic effects of RA.

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