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Two Pivotal Phase III Studies for Roche's ACTEMRA(TM) (tocilizumab) Demonstrate Significant Improvement in Rheumatoid Arthritis Symptoms
Date:11/7/2007

- New data from TOWARD study highlight significant improvements in RA

symptoms achieved with the unique inhibiting action of ACTEMRA that

specifically targets interleukin-6 receptors -

NUTLEY, N.J., Nov. 7 /PRNewswire-FirstCall/ -- Data from two pivotal multinational Phase III clinical trials demonstrating that Roche's ACTEMRA(TM) (tocilizumab) significantly improved the signs and symptoms of rheumatoid arthritis (RA) patients who failed to adequately respond to anti-rheumatic therapies -- also known as disease modifying agents (DMARDs) -- will be highlighted at the American College of Rheumatology (ACR) Annual Scientific Meeting in Boston, November 6-11.

Late-breaking data results from the TOWARD (Tocilizumab in cOmbination With traditional DMARD therapy) trial and OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate respONders) trial will both be featured in oral presentations. Additionally, study results of the OPTION trial will be featured at an ACR press conference on Saturday, November 10 at 8:30 a.m.

"We are very encouraged by the findings of this new TOWARD data which suggest ACTEMRA plus DMARDs demonstrates significant improvement in RA symptoms compared with DMARDs alone," said Mark C. Genovese, M.D., lead study investigator of the TOWARD trial and Associate Professor of Medicine at Stanford University School of Medicine. "The data from both studies further establish the efficacy of ACTEMRA and confirm that inhibiting interleukin-6 (IL-6) receptor is a novel method of reducing RA symptoms."

In the TOWARD trial, 61% of patients in the ACTEMRA plus DMARDs arm achieved a 20% reduction in RA symptoms compared with 25% of patients in the placebo arm (p<0.0001) at 24 weeks. Within two weeks there was a measurably higher ACR20 response with ACTEMRA than the control arm. In the OPTION trial, 59% of patients in the ACTEMRA 8 mg/kg plus methotrexate arm experienced a 20% reduction in symptoms versus 27% o
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SOURCE Roche
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