The Food and Drug Administration (FDA) has approved Simponi Aria® (golimumab; Janssen) for the treatment of patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis (pJIA), and has expanded the active psoriatic arthritis (PsA) indication to include this patient population. Previously, the treatment was indicated for active PsA in patients aged 18 years and older.
The approval was based on data from the multicenter, open-label, single-arm phase 3 GO-VIVA trial that evaluated the efficacy, safety and pharmacokinetics of golimumab, a tumor necrosis factor (TNF) blocker, in 127 patients aged 2 to 17 years with pJIA who had active polyarthritis, despite receiving methotrexate for at least 2 months. Patients with juvenile PsA were also included in the trial.
All patients received golimumab 80mg/m2 as an intravenous infusion at week 0, 4, and every 8 weeks through week 52. Findings of the study showed that efficacy was observed to be generally consistent with responses seen in patients with rheumatoid arthritis.
The efficacy of golimumab in pediatric patients with PsA was based on the pharmacokinetic exposure and extrapolation of the established efficacy of golimumab in adult PsA patients.
Simponi Aria is available as a 50mg/4mL strength solution for IV infusion; it is administered as a 30-minute infusion.
For more information visit janssen.com.
- Simponi Aria® (golimumab) approved by the US Food and Drug Administration for active polyarticular juvenile idiopathic arthritis and extension of its active psoriatic arthritis indication in patients 2 years of age and older. https://www.prnewswire.com/news-releases/simponi-aria-golimumab-approved-by-the-us-food-and-drug-administration-for-active-polyarticular-juvenile-idiopathic-arthritis-and-extension-of-its-active-psoriatic-arthritis-indication-in-patients-2-years-of-age-and-older-301141976.html. Accessed September 30, 2020.
- Simponi Aria [package insert]. Horsham, PA: Janssen Biotech, Inc.; 2020.
This article originally appeared on MPR