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Two-Year Data Reinforce Effect of ACTEMRA(R) (tocilizumab) in Inhibiting Progression of Joint Damage and Improving Physical Function in Rheumatoid Arthritis Patients
Date:5/24/2009

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In the study, ACTEMRA was generally well-tolerated and the overall safety profile after two years of treatment with ACTEMRA was consistent with previously reported data. Full data from this two-year study will be submitted to the U.S. Food and Drug Administration (FDA) and for presentation at a future international scientific meeting.

One-year LITHE data have been accepted for presentation at the 10th Annual Congress of the European League Against Rheumatism (EULAR), which will take place June 10-13, 2009, in Copenhagen, Denmark.

About the LITHE Study

The LITHE study was a three-arm, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of ACTEMRA (8 mg/kg and 4 mg/kg) plus methotrexate compared with placebo plus methotrexate in RA patients. Patients in the LITHE study received either ACTEMRA intravenously every four weeks plus methotrexate weekly or placebo infusions every four weeks plus methotrexate weekly. The LITHE study included nearly 1,200 patients from 137 sites in 15 countries, including the United States. The study aimed to show the inhibition of structural damage at the joints, as demonstrated by changes in validated radiographic parameters. The study also examined the improvement in physical function and disease signs and symptoms.

One-year data from the study showed the mean change in the combined Genant-modified Sharp score(3), which assesses progression of both joint erosion and joint space narrowing, was lower among ACTEMRA (8 mg/kg and 4 mg/kg) plus methotrexate-treated patients versus methotrexate plus placebo-treated patients (0.3, 0.3 versus 1.1, respectively; p<0.001). In addition, the one-year study results showed that 85 percent and 81 percent of patients treated with ACTEMRA (8 mg/kg or 4 mg/kg, respectively) experienced no progression of either joint erosion or joint space narrowing, as measured by the Genan
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SOURCE Roche
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