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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

ng SIMPONI 50 mg). All patients received SIMPONI from week 24. The trial was unblinded to investigators and patients after all patients reached week 52 and the week 52 database was locked. Investigators could choose to dose escalate patients receiving SIMPONI 50 mg to 100 mg based on clinical judgment. The primary endpoint was ACR 20 response at week 14 for combined SIMPONI groups and individual SIMPONI dose groups vs. placebo.

Through week 24, the placebo-controlled portion of the study, two percent of SIMPONI-treated patients experienced serious adverse events compared with six percent of patients in the placebo group. Injection site reactions occurred in five percent of patients receiving SIMPONI and three percent of patients receiving placebo.

At week 52, four malignancies were reported; one colon, one small-cell lung cancer and two cases of basal cell carcinoma. The small-cell lung cancer patient died; another patient died in a climbing accident. Also, one patient developed liver histoplasmosis. Through one year, an analysis comparing malignancies in the study with those in a Surveillance, Epidemiology and End Results (SEER) database suggested no difference between observed and expected cases.

About Rheumatoid Arthritis and Psoriatic 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.

Psoriatic arthritis is a chronic inflammatory disease that causes joint pain and swelling and can lead to joint destruction. PsA is frequently associated with inflamed, scaly, red patches of skin psoriasis and nail psoriasis. According to the National Psoriasis Foundation, up to 30 percent
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SOURCE Centocor Ortho Biotech Inc.
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