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Phase 3 Data Show New Anti-TNF, Golimumab, Significantly Improved Arthritis, Skin and Nail Manifestations in Patients with Psoriatic Arthritis
Date:11/7/2007

proach to the management of psoriatic arthritis, a potentially disabling inflammatory disease," said Arthur Kavanaugh, MD, Professor of Medicine, University of California, San Diego, School of Medicine, and lead study investigator. "These findings show golimumab to be promising in the treatment of multiple facets of the disease, namely the joints and skin, and support the utility of this anti-TNF-alpha treatment."

Joint and Psoriatic Improvements

Initial improvements as measured by ACR 20 at week 14 persisted through six months. At week 24, 52 percent and 61 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 20, compared with 12 percent of patients receiving placebo (P < 0.001). Significant improvements were observed in ACR 50 and ACR 70 measures at the same time points. At week 14, 30 percent and 28 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieved ACR 50, compared with 2 percent of patients receiving placebo (P < 0.001). At week 24, the results persisted with 32 percent and 38 percent of patients receiving golimumab 50 mg and golimumab 100 mg, respectively, achieving ACR 50 as compared with four percent of patients receiving placebo (P < 0.001). ACR 70, a more stringent response criterion, was achieved at week 14 by 12 percent of patients receiving golimumab 50 mg and 17 percent receiving golimumab 100 mg, compared with 1 percent of patients receiving placebo (P < 0.001). At week 24, 19 percent of patients receiving golimumab 50 mg and 21 percent of patients receiving golimumab 100 mg achieved ACR 70 as compared with 1 percent of patients receiving placebo (P < 0.001).

Patients receiving both doses of golimumab also experienced improvements in enthesitis and dactylitis, two common disease manifestations causing pain and swelling. Enthesitis, an inflammation of a tendon, ligament or joint capsule insertion to the bone and dactylitis, a swelling of digits in the ha
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SOURCE Centocor Inc.
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