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Actemra monotherapy significantly slows down damage to joints in patients with early aggressive RA

San Diego, U.S.A.: Roche today announced the results of the first Phase III study in rheumatoid arthritis (RA) conducted by Chugai in Japan which are being presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Diego, USA. These data conclude for the first time that Actemra in monotherapy shows superiority to conventional disease modifying anti-rheumatic drugs (DMARDs) in inhibiting radiographic progression of joint destruction. The data also show Actemra dramatically improves the painful and disabling symptoms of patients with rheumatoid arthritis.

Actemra (tocilizumab) is a humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody that offers a novel mechanism of action and may become a new therapeutic option for the treatment of RA.

Rheumatoid arthritis is a debilitating autoimmune disease in which the lining of the joints becomes inflamed causing irreversible joint damage and destruction. Patients experience pain, stiffness, swelling and ultimately loss of mobility.

"These data show the progression of patients' joint damage is substantially reduced over the one year period. Furthermore, the important role of IL-6 blockade is highlighted by the clinical benefits experienced in this Actemra monotherapy study. Following these impressive results, we look forward to the outcome of the large phase III programmes currently being run in Europe and the US with Actemra in combination with other anti-rheumatic drugs," commented Dr. Eduard Holdener, Head of Global Pharma Development, Roche.

Impressive results achieved with Actemra in patients with early, aggressive disease
Of the 302 patients evaluated in this monotherapy study, patients in the Actemra arm showed significantly less radiographic joint destruction compared to patients in the DMARDs control group as measured by change in total Sharp score (2.3 5.6 vs 6.1 11.4; p=0.001). Furthermore, Actemra was superior to DMARDs in
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Contact: Rebecca Hibble
rebecca_hibble@uk.cohnwolfe.com
44-207-331-5336
Cohn & Wolfe, London
17-Nov-2005


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