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New Study Demonstrates ACTEMRA(R) (tocilizumab) Inhibits Progression of Joint Damage in Rheumatoid Arthritis Patients
Date:5/9/2008

- Fifth International Phase III Study Shows Positive Results with X-ray

Data -

NUTLEY, N.J., May 9 /PRNewswire/ -- Roche today announced one-year results from a new two-year Phase III study showing that ACTEMRA(TM) (tocilizumab) can significantly inhibit progression of structural damage to joints in patients with rheumatoid arthritis (RA), a critical measure of effectiveness of an RA treatment. The study also demonstrated that ACTEMRA reduces disease signs and symptoms at one year. The LITHE study is the fifth international Phase III ACTEMRA trial to successfully meet its primary endpoints in patients with moderate to severe RA.

The one-year data from LITHE (TociLIzumab Safety and THE Prevention of Structural Joint Damage) trial showed that a greater proportion of patients treated with ACTEMRA (4 mg/kg or 8 mg/kg) plus methotrexate versus placebo plus methotrexate over 52 weeks achieved a significant reduction in the progression of structural joint damage, which is critical to RA patients because joint damage leads to disability. The study analysis included 1,196 patients from 137 trial sites in 15 countries. Twenty-eight percent of the patients were from the United States.

ACTEMRA was generally well tolerated; the most common adverse events reported more frequently in the ACTEMRA arm of the LITHE trial were upper respiratory tract infections, nasopharyngitis, hypertension, headache and an increase in transaminases.

"At one year, the results from the LITHE trial clearly demonstrate that ACTEMRA could be an effective component in the battle against the long-term debilitating effects of RA, including joint damage and loss of physical function," said Lars Birgerson, M.D., Ph.D., Global Head Medical Affairs, Roche. "The ACTEMRA clinical development program was designed to establish ACTEMRA as a first-line biologic in the treatment of RA. When you consider that this is the fifth consecutive successful
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