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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

- Fifth International Phase III ACTEMRA Study Meets its Primary Endpoints -

NUTLEY, N.J., May 25 /PRNewswire/ -- Roche today announced that two-year data from the LITHE (TociLIzumab Safety and THE Prevention of Structural Joint Damage) study demonstrated that ACTEMRA(R) (tocilizumab) continued to inhibit the progression of structural damage to joints in patients with rheumatoid arthritis (RA). The study also showed that patients receiving ACTEMRA experienced improved physical function, as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) scores(1). The LITHE study is the fifth international Phase III study in the extensive ACTEMRA clinical development program to successfully meet its primary endpoints in patients with moderately to severely active RA.

"The one-year LITHE results demonstrated that ACTEMRA significantly inhibited the progression of structural joint damage, which is a major cause of disability and loss of physical function for RA patients," said Kenneth Bahrt, M.D., Global Medical Director, Autoimmunity, Roche. "We are extremely pleased by these two-year LITHE data as they confirm the previous study findings, and also suggest that the effect of ACTEMRA actually improves over time."

The two-year data from the LITHE study showed that patients treated with ACTEMRA maintained consistently high disease remission rates according to DAS28 criteria, which measures disease activity in RA patients(2). The study also showed that a greater proportion of patients treated with ACTEMRA (8 mg/kg and 4 mg/kg) plus methotrexate achieved a significant reduction in the progression of structural joint damage during 24 months of treatment compared with patients receiving placebo plus methotrexate. The outcome was determined by X-ray evidence of the progression of bone erosion and narrowing of joint spaces, as measured by the Genant-modified Sharp score(3).'/>"/>

SOURCE Roche
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