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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

groups and one percent in the group receiving placebo plus methotrexate experienced serious infections. Rates of injection site reactions were five percent in the combined SIMPONI plus methotrexate groups and three percent in the group receiving placebo plus methotrexate.

At week 52, 11 percent of patients receiving placebo plus methotrexate reported serious adverse events compared with 17 percent of patients receiving SIMPONI 100 mg plus placebo, 14 percent of patients receiving SIMPONI 50 mg plus methotrexate and 18 percent of patients receiving SIMPONI 100 mg plus methotrexate. Two percent of patients receiving placebo plus methotrexate reported serious infections at week 52 compared with 17 percent of patients receiving SIMPONI 100 mg plus placebo, 14 percent of patients receiving SIMPONI 50 mg plus methotrexate and 18 percent of patients receiving SIMPONI 100 mg plus methotrexate. Four patients participating in the study, two receiving SIMPONI 50 mg plus methotrexate and two receiving SIMPONI 100 mg plus methotrexate, developed malignancies at week 52; two patients developed breast cancer, one patient developed squamous cell and basal cell skin cancer and one patient was diagnosed with basal cell cancer. One patient receiving SIMPONI 100 mg plus placebo died from diarrhea, colitis and sepsis.

About the GO-REVEAL Trial

The GO-REVEAL trial involved 405 adults with PsA. Patients with at least three swollen and tender joints and active psoriatic skin lesions of at least two cm in diameter were randomly assigned to receive subcutaneous injections of placebo or SIMPONI (50 or 100 mg) every four weeks for two years. The primary endpoint was ACR 20 response at week 14 for combined SIMPONI groups and individual SIMPONI dose groups vs. placebo. At week 16, patients with inadequate arthritis response were switched to SIMPONI 50 mg (patients originally receiving placebo) or SIMPONI 100 mg (patients originally receivi
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SOURCE Centocor Ortho Biotech Inc.
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