Study Supports Use of Intravenous Golimumab in Treating Psoriatic Arthritis

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:

• At week 14, 75.1% of patients in the golimumab arm achieved a response ACR20 compared with 21.8% of patients in the placebo arm (P < 0.001).
• At week 14, 24.5% of patients in the golimumab arm achieved a response of ACR70 (70% improvement), compared with 2.1% of patients in the placebo arm (P < 0.001).
• At week 14, 59.2% of patients in the golimumab arm achieved a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI75) compared with 13.6% of patients in the placebo arm (P < 0.001).
• At week 24, 53.5% of patients in the golimumab arm achieved a response of ACR50 (50% improvement) compared with 6.3% of the placebo arm (P < 0.001).
• Separation between the treatment groups was observed at week 2 for ACR50 and 70 responses, and this separation was maintained through week 24. There was no difference in ACR20, 50, and 70 response rates among patients who received concomitant methotrexate and those who did not.
• Adverse events (AE) were reported in 46.3% of patients in the golimumab arm and in 40.6% of patients in the placebo arm; infections were the most commonly reported AE.

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.