Recently reported results of a phase 3 study found that patients with psoriatic arthritis (PsA) who received intravenous golimumab (Simponi) had significantly greater improvements in the signs and symptoms of PsA through week 24 than did patients who received placebo.
Anti—tumor necrosis factor (anti-TNF) agents have revolutionized the treatment of patients with psoriatic arthritis (PsA), and have substantially improved clinical outcomes compared to earlier, conventional therapies (such as disease-modifying anti-rheumatic drugs or non-steroidal anti-inflammatory drugs). Recently reported results of a phase 3 study found that patients with PsA who received intravenous golimumab (Simponi), an anti-TNF agent, had significantly greater improvements in the signs and symptoms of PsA through week 24 than did patients who received placebo.
The GO-VIBRANT study, conducted by Arthur Kavanaugh, MD, and colleagues, included patients (n = 480) from 90 sites in 11 countries who were aged 18 years or more, were naïve to biologic therapy, and had active PsA despite conventional therapy. Concomitant methotrexate treatment was allowed. Patients were randomized to receive either intravenous placebo (n = 239) or golimumab at 2 mg per kg (n = 241) at weeks 0, 4, 12, and 20 of the study. The study’s primary endpoint was the proportion of patients meeting the American College of Rheumatology’s 20% improvement criteria (ACR20) at week 14.
The researchers found the following:
The researchers concluded that patients with PsA who were treated with intravenous golimumab experienced significantly greater improvements in disease activity compared with patients receiving placebo, and that the AEs reported in the trial were consistent with the established safety profile of anti-TNF agents. The study will continue through 1 year, when updated results will be presented.
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