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Golimumab Significantly Improves Active Psoriatic Arthritis, Nail Psoriasis HOBOKEN, NJ -- April 7, 2009 -- Golimumab significantly improves active psoriatic arthritis and associated skin and nail psoriasis, according to a study published in the April issue of the journal of Arthritis & Rheumatism. The phase 2, multicentre, randomised, placebo-controlled, double-blind, study evaluating the effect of a anti-tumor necrosis factor alpha (anti-TNFalpha) agent inhibitor on nail psoriasis, was led by Arthur Kavanaugh, MD, University of California San Diego, La Jolla, California. The study involved 405 patients with active psoriatic arthritis even after having taken disease-modifying antirheumatic drugs or nonsteroidal anti-inflammatory drugs (NAIDs). Patients were randomised to receive subcutaneous injections of placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks for 24 weeks. Patients with less than 10% improvement in swollen and tender joints at week 16 were switched from placebo to 50 mg golimumab or from 50 mg to 100 mg. The primary end point of the study was the proportion of patients who met the American College of Rheumatology 20% improvement criteria (ACR20 response) at week 14. This response included at least a 20% improvement in swollen and tender joint counts and other measures such as pain, disease activity, physical function, and C-reactive protein. ACR50 and ACR70 responses were defined by at least 50% and at least 70% improvement. Golimumab was efficacious and generally well tolerated. An ACR20 response was achieved at week 14 by 51% of patients receiving golimumab 50mg and 45% of those receiving golimumab 100mg, compared with 9% of placebo-treated patients. In addition, significantly more golimumab-treated patients than placebo-treated patients achieved ACR50 and ACR70 responses and those who initially showed little improvement and switched from placebo to golimumab or increased their dosage also showed improvement. Patients treated with the drug had significant improvement in physical function and health-related quality of life, as well as significant improvement in enthesitis. In addition to improving arthritic symptoms, golimumab also improved psoriasis symptoms with 40% of the 50 mg group and 58% of the 100 mg group having at least a 75% improvement in psoriasis symptoms, compared with 3% in the placebo group. "The safety profile of golimumab in psoriatic arthritis was similar to other anti-TNF agents that have been studied in this disease," the authors wrote. "Subcutaneous administrations were well tolerated. Only a small number of patients had injection site reactions, which were mostly mild." "This was also the first placebo-controlled study evaluating the effect of an anti-TNFalpha on nail psoriasis, which affected about 70% of the patients involved in the study," the continued. "Significant improvements in nail symptoms were seen in those treated with golimumab as early as week 14 and were maintained or improved through the end of the study period." SOURCE: Wiley-Blackwell E-mail this page to a friend or colleague! To print, use this version