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Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis
Date:6/9/2009

Long-Term Data in Patients Receiving Every-Four-Week Subcutaneous SIMPONI Presented at 2009 EULAR Annual Congress

COPENHAGEN, June 9 /PRNewswire/ -- Findings from open-labeled, uncontrolled extensions of two randomized, placebo-controlled Phase 3 studies showed that subcutaneous (SC) injections of SIMPONI(TM) (golimumab) 50 mg or 100 mg every four weeks provided persistent improvements in the signs and symptoms in patients with psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Investigators reported these new data from the long term treatment extensions of the GO-REVEAL and GO-RAISE trials at the 2009 European League Against Rheumatism (EULAR) Annual Congress.

In the Golimumab - A Randomized EValuation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF MonocLonal Antibody (GO-REVEAL) study, patients with active PsA were randomized to placebo (n=113), SIMPONI 50 mg (n=146) or SIMPONI 100 mg (n=146). Of the 405 patients originally randomized in the Phase 3 study, a two-year observational analysis of 276 patients remaining in the study and evaluated at two years was performed. Sixty-four of 70 patients who received SIMPONI 50 mg and 95 of 130 patients who received SIMPONI 100 mg achieved ACR 20, respectively. Forty-three of 76 patients receiving SIMPONI 50 mg who switched to SIMPONI 100 mg in early escape also achieved ACR 20. At least 50 percent improvement in arthritis signs and symptoms (ACR 50) was seen in 47 of 70 patients receiving SIMPONI 50 mg and 70 of 130 patients receiving SIMPONI 100 mg, respectively, while 70 percent improvement (ACR 70) was seen in 31 of 70 patients and 48 of 130 patients in the SIMPONI 50 mg and 100 mg dose groups, respectively.

In a similar analysis, SIMPONI-treated patients also experienced sustained improvements in skin manifestations of PsA through two years. Patients with great
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SOURCE Centocor Ortho Biotech Inc.
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