FDA approves Simponi Aria for polyarticular JIA, expands PsA indication to children
The FDA has approved Simponi Aria for the treatment of polyarticular juvenile idiopathic arthritis in patients aged 2 years and older, while also expanding its psoriatic arthritis indication for this patient population, according to a press release from Janssen.
Previously approved in the United States for adult patients with moderately to severely active RA, active PsA and active ankylosing spondylitis, Simponi Aria (golimumab) is now the first TNF inhibitor approved for pediatric use in both active polyarticular juvenile idiopathic arthritis (pJIA) and active PsA.
“Polyarticular JIA and PsA are highly complex diseases that impact each patient differently, and many caregivers struggle to find the right treatment for young patients,” Andrew Greenspan, MD, vice president of United States Medical Affairs at Janssen Immunology told Healio Rheumatology. “We’re so pleased about the latest approval of Simponi Aria, as it not only brings a new option to young patients living with these diseases, but also adds to the growing body of evidence for this treatment.”
The FDA based its approval on results from the phase 3 GO-VIVA trial, a 52-week open-label study among children with JIA (n=127) with active polyarthritis aged 2 to 17 years who had active arthritis in five or more joints, despite receiving treatment with methotrexate for at least 2 months. The trial was conducted as a post-marketing requirement under the Pediatric Research Equity Act after the FDA approval of Simponi Aria for adults with moderately to severely active RA in 2013.
According to study results, pharmacokinetic exposure of golimumab in pediatric patients was consistent with that of two pivotal phase 3 clinical trials of golimumab in adult patients with moderately to severely active RA and active PsA. Additionally, researchers found that the efficacy was largely consistent with responses in adult patients with RA.
The Janssen press release also noted that the observed safety profile of golimumab in pJIA was consistent with that found in patients with RA and PsA, with common serious adverse events including upper respiratory infection, abnormal liver tests, decreased white blood cells, viral infections, bronchitis, high blood pressure and rash.
“Simponi Aria is the first and only fully human anti-TNF biologic agent administered by IV approved for this patient population,” Greenspan told Healio Rheumatology. “We at Janssen have been researching anti-TNF biologic agents for immune-mediated diseases for more than 20 years, and it’s encouraging to see this milestone come to fruition for Simponi Aria in pJIA and pediatric PsA patients.”