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New SIMPONI(TM) Data Show Inhibition of Joint Damage in Patients With Rheumatoid Arthritis and Psoriatic Arthritis
Date:10/19/2009

h, Professor of Medicine at the University of California San Diego's Division of Rheumatology, Allergy and Immunology and lead study investigator. "These findings are important as they offer new information about the efficacy of golimumab in the treatment of this complex disease."

Joint erosion (when inflammation causes bones to wear away at the joint) and joint space narrowing (when the gap between bones closes), were also measured in the study. In patients reporting no erosion at baseline, 87 percent receiving SIMPONI 50 mg remained erosion free at week 24 compared with 72 percent of patients in the placebo group (P=0.003). For patients reporting no joint space narrowing at baseline, 97 percent receiving SIMPONI 50 mg remained free of joint space narrowing at week 24 compared with 88 percent in the placebo group (P=0.008).

In April 2009, the U.S. Food and Drug Administration (FDA) and Health Canada approved SIMPONI 50 mg as a once-monthly subcutaneous injection for the treatment of moderately to severely active RA, active PsA and active ankylosing spondylitis. In October 2009, the European Commission approved SIMPONI as a once-monthly, subcutaneous injection for the treatment of moderate to severe, active RA, active and progressive PsA and severe, active ankylosing spondylitis.

About GO-BEFORE

GO-BEFORE, a Phase 3, multi-center, double-blind, placebo-controlled study included 637 methotrexate-naïve adults with RA and was designed to compare ACR 50 response at week 24 in patients receiving SIMPONI plus methotrexate compared with patients receiving placebo plus methotrexate. Patients with active RA who had more than four tender and swollen joints were included in the multicenter study. Patients were randomly assigned into four groups; Group 1 included patients receiving placebo every four weeks plus methotrexate 20 mg per week; Group 2 included patients receiving golimumab 100 mg e
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SOURCE Centocor Ortho Biotech Inc.
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