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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

red with an increase of 1.37 (+/- 4.56) score in the group receiving placebo plus methotrexate (P<0.015). The reduction in progression of vdH-S scores seen with the 50 mg and 100 mg doses was comparable.

In a second study, the GOlimumab FOR subjects With Active RA Despite Methotrexate (GO-FORWARD) clinical trial, vdH-S changes from baseline were minimal in all groups studied (including the placebo arm) which prevented any significant effect of SIMPONI to be detected. A lack of progression in the placebo group may have been due to the short placebo-controlled period of the trial and relatively less active patient population than in previously reported RA trials.

Psoriatic Arthritis

In the Golimumab - A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody (GO-REVEAL) trial, patients with active PsA receiving SIMPONI 50 mg showed significantly less progression of structural damage at week 24 compared with patients receiving placebo plus methotrexate, and the benefit was maintained through 52 weeks. Structural damage was measured using the vdH-S score. The mean change (+/- standard deviation) from baseline in patients receiving SIMPONI was a decrease of 0.16 (+/- 1.31) score at week 24 compared with an increase of 0.27 (+/- 1.26) score in the placebo group (P=0.011). At week 24 all placebo patients began receiving SIMPONI 50 mg. At week 52, the mean change from baseline in total vdH-S score was -0.22 (+/- 1.64) in patients initially randomized to SIMPONI 50 mg at baseline while the mean score in the group who crossed over from placebo to SIMPONI at week 24 was 0.22 (+/- 1.38).

"Results from the GO-REVEAL study show that treatment with golimumab inhibited joint destruction in patients with active psoriatic arthritis," said Dr. Arthur Kavanaug
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SOURCE Centocor Ortho Biotech Inc.
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