20 October 2017 - Simponi Aria is the only fully-human anti-TNF-alpha infused therapy now approved for psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis.

Janssen Biotech announced today that the U.S. FDA has approved Simponi Aria (golimumab), the only fully-human anti-tumour necrosis factor (TNF)-alpha therapy administered via a 30-minute infusion, for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS). Today’s approvals follow the first FDA approval of Simponi Aria in 2013 for the treatment of moderately to severely active rheumatoid arthritis.

The approvals of Simponi Aria for PsA and AS are based on two large-scale, pivotal Phase 3 studies involving more than 600 patients. In both studies, the primary endpoints were met, with a higher proportion of patients demonstrating significant improvement in the signs and symptoms of PsA and AS in the groups receiving treatment with Simponi Aria compared with those receiving placebo. In the GO-VIBRANT (PsA) study, 755 of patients receiving Simponi Aria, compared with 22% of patients receiving placebo (P < 0.001), achieved at least a 20% improvement in the American College of Rheumatology (ACR20) response at week 14. Treatment with Simponi Aria resulted in the inhibition of the progression of structural joint damage and improvement in physical function associated with PsA at week 24. In the GO-ALIVE (AS) study, 73% of patients receiving Simponi Aria, compared with 26 percent of patients receiving placebo (P < 0.001), achieved at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16.

Read Janssen press release