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

11/16/05

First Phase III data presented at the ACR Annual Meeting

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 preventing both erosion and joint space narrowing. Disease Activity Scores (DAS) were 6.9 and 6.8 at baseline, Actemra and DMARDs control groups respectively, indicating very active disease. Following one year of treatment, DAS in the Actemra arm fell to 2.5 and to 5.7 in the DMARDs control group. ACR2 response rates in the Actemra arm were significantly higher than those in the DMARDs control arm: percentages of Actemra patients achieving ACR20, 50 and 70 were 89%, 70% and 47% respectively compared to 35%, 14% and 6% respectively in the DMARDs group. Results of this magnitude have not been previously achieved in rheumatoid arthritis patients who have early aggressive disease.

Actemra generally well tolerated
The overall incidence of adverse events including laboratory abnormalities was 96% and 87% in the Actemra and DMARDs control arms respectively. While lipid increases were reported in the Actemra group, the mean cholesterol level stabilized around the upper limit of normal. No tuberculosis was observed and Actemra monotherapy was generally well tolerated.

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