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New Actemra data shows significant benefit for patients suffering from rheumatoid arthritis
Date:11/8/2007

RD and OPTION studies will be part of the application to Regulatory Authorities that we intend to submit by the end of the year."

About TOWARD Study

Patients were randomized to receive either Actemra intravenously (8mg/kg) every four weeks plus DMARDs weekly or placebo infusions plus DMARDs weekly. The multicentre study treated 1,216 patients at 130 trial sites in 18 countries, including the U.S. At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus DMARDs compared to the control group. The ACR20, ACR50 and ACR70 was achieved in 61%, 38% and 21%, respectively, of Actemra plus DMARDs patients versus 25%, 9% and 3%, respectively, in the placebo plus DMARDs arm. Disease remission was demonstrated in 30% of Actemra patients (DAS28 <2.6) compared with 3% of patients treated with only DMARDs.

About OPTION Study

In the OPTION trial, 623 patients were randomized to receive Actemra intravenously (either 4mg/kg or 8mg/kg) every four weeks plus methotrexate weekly or placebo infusions plus methotrexate weekly. The study was conducted in 73 trial sites in 17 countries, outside the United States. At 24 weeks significantly more patients achieved a 20%, 50% and 70% (ACR20, ACR50 and ACR70) reduction of symptoms with Actemra plus methotrexate compared to the control arm. Fifty nine per cent, 44% and 22%, respectively, of patients treated with Actemra (8mg/kg) plus methotrexate achieved ACR20, ACR50 and ACR70 compared with 27%, 11% and 2%, respectively, in the control group. Disease remission was demonstrated in 28% of Actemra patients (DAS28 <2.6) compared with 1% of patients treated with methotrexate alone.

Other parameters measured in both studies included levels of C-reactive protein (CRP), a marker of inflammation, fatigue and haemoglobin. Patients on Actemra showed a rapid normalisation of the CPR levels within two weeks and a rapid improvem
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Contact: Nicole Moores
nicole_moores@uk.cohnwolfe.com
44-020-733-15337
Cohn & Wolfe, London
Source:Eurekalert

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