More than 70 percent of patients on Simponi Aria (golimumab) meet primary endpoint in phase III ankylosing spondylitis study- Janssen

Janssen announced new findings from a pivotal Phase III study showing the efficacy and safety profile of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy Simponi Aria (golimumab) in the treatment of active ankylosing spondylitis (AS). Data from the GO-ALIVE study showed that 73.3 percent of patients with active ankylosing spondylitis receiving Simponi Aria 2 mg/kg achieved the study's primary endpoint of at least a 20 percent improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20) at week 16, compared with 26.2 percent of patients receiving placebo. In addition to meeting the primary endpoint of ASAS20 at week 16, all statistically-controlled secondary endpoints in the GO-ALIVE study were also met with statistical significance in comparisons of Simponi Aria versus placebo at week 16. Results show 47.6 percent of patients receiving Simponi Aria achieved an ASAS40 response compared with 8.7 percent of patients receiving placebo. Additionally 41.0 percent of Simponi Aria patients achieved a BASDAI 50 response compared with 14.6 percent of placebo patients. Mean change from baseline in BASFI was -2.4 for the Simponi Aria group compared with -0.5 for the placebo group.

Additional assessments demonstrated statistically significant superiority of Simponi Aria compared with placebo. Through week 16, 32.4 percent of patients receiving Simponi Aria and 23.3 percent of patients receiving placebo had one or more adverse events (AEs). The most common type of AE was infection, 11.4 percent reported in the Simponi Aria group and 7.8 percent reported in the placebo group. Through week 28, 34.8 percent of Simponi Aria-treated patients experienced one or more AEs, and nasopharyngitis was the most common AE reported (5.4 percent) and serious AEs reported in the Simponi Aria group included one case of pancreatitis and one case of pneumonia. Data from GO-ALIVE, which will be part of an upcoming submission to the U.S. FDA seeking approval of Simponi Aria for the treatment of active ankylosing spondylitis, are being presented for the first time at the 2016 ACR/ARHP Annual Meeting.