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ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies
Date:6/13/2008

- Phase III monotherapy study shows ACTEMRA is first and only biologic to demonstrate statistical superiority over methotrexate after 24 weeks of

treatment -

PARIS, June 13 /PRNewswire/ -- Patients who suffer the chronic and debilitating effects of rheumatoid arthritis (RA) -- despite treatment with current therapies -- achieved significant improvements in signs and symptoms when treated with Roche's ACTEMRA(R) (tocilizumab) alone or in combination with methotrexate compared with methotrexate alone, according to two international Phase III studies presented by researchers at the European Congress of Rheumatology (ECR) held by the European League Against Rheumatism (EULAR) in Paris.

Data from two new Phase III studies -- RADIATE and AMBITION trials -- will be highlighted as oral presentations at the congress, along with 21 additional abstracts involving ACTEMRA, a novel interleukin-6 (IL-6) receptor inhibitor being studied for the treatment of moderate to severe RA. Importantly, findings from the RADIATE study were also published online this week in the Annals of the Rheumatic Diseases.

In the RADIATE study, which evaluated difficult-to-treat patients who failed to respond to prior anti-TNF therapies, 50 percent of ACTEMRA-treated patients achieved a 20 percent (ACR20(1)) reduction in signs and symptoms. The AMBITION study showed that significantly more patients receiving ACTEMRA achieved a 20 percent improvement in their signs and symptoms [ACR20: 70%]. No previous biologic therapy has demonstrated statistically significant superiority compared to methotrexate in this important clinical parameter at week 24. In addition, nearly one-third of all ACTEMRA patients from both studies reached disease remission (as defined by DAS28 <2.6(2)).

"We are very encouraged by the results of the AMBITION study that shows for the first time that treatment with a single biologic agent is superior to methotrexate at s
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SOURCE Roche
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