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ACTEMRA (R) (tocilizumab) Significantly Reduced Signs and Symptoms of Rheumatoid Arthritis in Patients Who Failed Prior Treatments
Date:10/25/2008

- Results of two Phase III studies affirmed the clinical benefits of ACTEMRA -

NUTLEY, N.J., Oct. 25 /PRNewswire/ -- Data from two Phase III studies showed that patients who suffer from the debilitating and painful effects of rheumatoid arthritis (RA) achieved significant improvements in signs and symptoms when treated with ACTEMRA(R) (tocilizumab) alone or in combination with methotrexate compared with methotrexate alone. The final results of both studies will be presented as oral presentations, along with 13 other abstracts which evaluate ACTEMRA in patients with moderately to severely active RA, at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Francisco, October 24-29.

Results of the RADIATE study, which evaluated difficult-to-treat patients who failed to respond to prior anti-tumor necrosis factor (TNF)-alpha therapies, demonstrated that half of patients treated with ACTEMRA (8 mg/kg) in combination with methotrexate achieved a 20 percent reduction (ACR20)(1) in RA signs and symptoms, compared with 10 percent of patients treated with methotrexate alone.

"Despite treatment with existing therapies, many patients with RA continue to experience symptoms of joint pain and stiffness," said Mark Genovese, M.D., Professor of Medicine at Stanford University School of Medicine. "The compelling results of these studies further support the efficacy and safety of ACTEMRA as a potential new treatment option for managing the chronic signs and symptoms of this debilitating disease."

The AMBITION study, which examined the effects of ACTEMRA (8 mg/kg) as monotherapy, showed that 70 percent of patients receiving ACTEMRA achieved a 20 percent improvement in their signs and symptoms (ACR20), compared with 53 percent of patients receiving methotrexate alone. The study not only successfully met its primary endpoint of non-inferiority in patients with moderate to severe RA, but also demonstrated superiority over the stand
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SOURCE Hoffmann-La Roche Inc.
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4. Roche Submits Application for FDA Approval of ACTEMRA(R) for the Treatment of Rheumatoid Arthritis
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