Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Simponi Aria (golimumab) for the treatment of adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).
Simponi Aria, a fully-human anti-tumor necrosis factor (TNF)-alpha therapy, was initially approved in 2013 for the treatment of moderately to severely active rheumatoid arthritis.
The FDA’s expanded approvals were supported by data from two Phase 3 multicenter, randomized, double-blind, placebo-controlled studies (GO-VIBRANT and GO-ALIVE) that included >600 patients. Study patients were randomized to Simponi Aria 2mg/kg at Weeks 0, 4, and then every 8 weeks thereafter or placebo at Weeks 0, 4, 12, and 20 with crossover to Simponi Aria at Week 16 (AS) or 24 (PsA). For both studies, there was a higher proportion of patients showing significant improvement in the signs and symptoms of PsA and AS in the Simponi Aria arm vs. placebo.
In the GO-VIBRANT study, 75% of adults with PsA who received Simponi Aria achieved ≥20% improvement in the ACR20 response at Week 14 vs. 22% of patients who received placebo (P<0.001). Also, patients treated with Simponi Aria showed reduced progression of structural joint damage and improved physical function associated with PsA at Week 24.
In the GO-ALIVE study, 73% of patients with AS who received Simponi Aria achieved ≥20% improvement in the ASAS20 at Week 16 vs. 26% of patients who received placebo (P<0.001).
Simponi Aria is available as a 50mg/4mL strength solution for IV infusion; it is administered as a 30-minute infusion.
For more information call (800) 526-7736 or visit SimponiAria.com.