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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

golimumab 100 mg, respectively, achieved PASI 75 at week 14, compared with 3 percent of patients receiving placebo (P < 0.001). At week 24, PASI 75 responses improved to 56 percent (golimumab 50 mg) and 66 percent (golimumab 100 mg), compared with 1 percent of placebo patients (P < 0.001). In additional analyses, patients receiving golimumab 50 mg and golimumab 100 also experienced improvements in nail psoriasis as measured by NAPSI and these improvements were sustained over time.

"These Phase 3 data show that once monthly subcutaneous administrations of golimumab 50 mg and golimumab 100 mg significantly improved articular and psoriatic manifestations in patients with psoriatic arthritis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "We are encouraged by these results and believe golimumab holds great promise as a new anti-TNF-alpha therapy for physicians and patients in need of additional therapeutic options."

Disease Activity and Physical Function Improvements

The majority of golimumab-treated patients in the study were classified as good or moderate responders as measured by the Disease Activity Score 28 (DAS28), which measures tender and swollen joints and overall disease activity including measurement of serum C-reactive protein (CRP) levels. After 14 weeks of treatment, 66 percent of patients receiving golimumab 50 mg were DAS28 responders, as were 67 percent of patients receiving the 100 mg dose, compared with 24 percent of patients receiving placebo (P < 0.001). At week 24, 64 percent and 78 percent of patients receiving golimumab 50 mg and 100 mg, respectively, were DAS28 responders, compared with 24 percent of patients receiving placebo (P < 0.001).

Patients receiving golimumab in the study also experienced significant improvements in physical function, as measured by the Health Assessment Questionnaire (HAQ). At week 14, patients receiving golimumab 50 mg experienced a mean i
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SOURCE Centocor Inc.
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