New SIMPONI(TM) Data Show Long-Term Efficacy in Treatment of Rheumatoid...(At week 16 patients with at least a 20 p...)

Date:10/19/2009

At week 16, patients with at least a 20 percent response (ACR 20) were entered into an early escape and patients who had been receiving placebo plus methotrexate received SIMPONI 50 mg plus methotrexate; methotrexate was added to the SIMPONI 100 mg with placebo group, the group receiving SIMPONI 50 mg plus methotrexate was given SIMPONI 100 mg and the SIMPONI 100 mg plus methotrexate group was not changed. The patients continued receiving treatment through 52 weeks.

Serious adverse events were reported in 11, 17, 14 and 18 percent of patients in each group, respectively, and two, six, two and eight percent of patients, in each group respectively, experienced a serious infection. From week 24 through week 52, nine serious infections were reported; three in patients receiving SIMPONI 50 mg plus methotrexate, four in patients receiving SIMPONI 100 mg plus placebo and two in patients taking SIMPONI 100 mg plus methotrexate. There were also four malignancies reported between week 24 and week 52; two patients receiving SIMPONI 50 mg plus methotrexate were diagnosed with squamous and basal cell cancer and breast cancer, respectively, and two patients receiving SIMPONI 100 mg plus methotrexate were diagnosed with basal cell cancer and breast cancer, respectively.

About Rheumatoid Arthritis

Rheumatoid arthritis is characterized by persistent and progressive joint inflammation, causing pain, stiffness and functional disability. The Arthritis Foundation estimates that approximately 1.3 million people in the United States are affected by RA. For more information, visit the Arthritis Foundation.

About SIMPONI

SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. The
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SOURCE Centocor Ortho Biotech Inc. Copyright©2009 PR Newswire. All rights reserved

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