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| |  Golimumab Significantly Improves Joint, Skin, and Nail Manifestations of Psoriatic Arthritis: Presented at ACR By Bruce Sylvester BOSTON, MA -- November 12, 2007 -- Researchers from the largest phase 3 study ever conducted with a biologic treatment report that patients with active psoriatic arthritis (PsA) treated with monthly subcutaneous injections of investigative golimumab achieved significant and sustained improvements in joint and skin manifestations of the disease. The findings were presented here in an oral session on November 10 at the 71st annual meeting of the American College of Rheumatology (ACR). "Over 30% of subjects in both golimumab-dosing groups achieved PASI90 [Psoriasis Area and Severity Index]," said Philip Mease, MD, Clinical Professor, University of Washington School of Medicine, and Chief of Clinical Research, Department of Rheumatology, Swedish Hospital Medical Center, Seattle, Washington. "We saw no drug-related deaths, tuberculosis, or opportunistic infections," he added. The investigators randomized 405 adult PsA patients with at least 3 or more swollen and tender joints to receive subcutaneous injections of placebo or golimumab 50 mg or 100 mg at weeks 0, 4, 8, 12, 16, and 20. Subjects who responded inadequately by week 16 were switched in a blinded manner to golimumab 50 mg (placebo patients) or golimumab 100 mg (all golimumab patients). For placebo and golimumab 50-mg subjects, the last observation prior to change in treatment was carried forward for week-24 efficacy analyses. The investigators used observed values at week 24 for golimumab 100-mg patients. Concomitant methotrexate use was permitted but not required. The primary endpoint of the study was ACR20 (>=20% improvement in rheumatoid arthritis signs and symptoms) at week 14. Dr. Mease reported that, at week 14, 51% of the golimumab 50-mg subjects and 45% of the 100-mg subjects had achieved at least an ACR20, which was statistically significant in both instances when compared with 9% ACR20 for placebo patients (P <.001 for both comparisons). He also reported that through week 24, golimumab subjects achieved sustained, significant improvements in skin and nail manifestations of the disease, as measured by a PASI75 in subjects who had at least 3% body-surface disease at baseline, and as measured by the Nail Psoriasis Severity Index (NAPSI). "In patients with active PsA, GLM [golimumab] 50 and 100 mg q 4 weeks [every four weeks] significantly improved active PsA and psoriatic skin and nail disease through week 24. GLM was generally well tolerated," the authors concluded. The study was sponsored by Centocor, Inc., a subsidiary of Johnson and Johnson.
[Presentation title: Golimumab, a New, Human, TNF-alpha Antibody Administered as a Monthly Subcutaneous Injection in Psoriatic Arthritis: 24-Week Efficacy and Safety Results of the Randomized, Placebo-Controlled GO-REVEAL Study. Abstract L14]
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