Pivotal phase III GO-VIBRANT study of Simponi Aria (golimumab) shows efficacy in psoriatic arthritis- Janssen R&D

Janssen Research & Development announced results from the pivotal Phase III GO-VIBRANT study that showed the significant efficacy of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy Simponi Aria (golimumab) in the treatment of active psoriatic arthritis. In GO-VIBRANT, 75.1 percent of patients with active psoriatic arthritis receiving Simponi Aria 2 mg/kg achieved at least a 20 percent improvement in arthritis signs and symptoms as measured by the American College of Rheumatology (ACR20) at week 14, the study's primary endpoint, compared with 21.8 percent of patients receiving placebo (P < 0.001). Simponi Aria also showed significant improvement across all secondary endpoints evaluating improvements in skin symptoms, joint damage and health-related quality of life measures.

Treatment at weeks 0 and 4 and every eight weeks thereafter resulted in statistically significant improvements in all secondary endpoints: at week 14, among patients receiving Simponi Aria, 43.6 percent and 24.5 percent achieved a 50 and 70 percent improvement in signs and symptoms (ACR50 and ACR70), respectively, compared with 6.3 percent and 2.1 percent of patients receiving placebo, respectively. A greater proportion of Simponi Aria-treated patients achieved a 75 percent improvement in psoriasis as measured by the Psoriasis Area Severity Index (PASI 75) compared with patients receiving placebo (59.2 percent versus 13.6 percent, respectively).

At week 24, among patients receiving Simponi Aria, 53.5 percent achieved ACR50 compared with 6.3 percent of patients receiving placebo. Analyses of X-rays at week 24 showed significant inhibition of the progression of structural damage in patients receiving Simponi Aria compared with patients receiving placebo, with a mean change from baseline in total modified van der Heijde Sharp scores (vdH-S) of -0.36 vs. 1.95, respectively. The vdH-S score is an X-ray measure of joint destruction and damage, including joint erosion and joint space narrowing, with higher mean change in scores indicating greater structural damage and lower mean change in scores indicating less structural damage.

Data from GO-VIBRANT are being presented for the first time at the Annual European Congress of Rheumatology (EULAR) 2017. Simponi Aria is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis and the treatment of adults with ankylosing spondylitis.