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SIMPONI ARIA® Receives Approval for Pediatric Indications

The FDA expands SIMPONI ARIA® use for psoriatic arthritis to the pediatric population.

On September 30, 2020, the U.S. Food and Drug Administration (FDA) approved the use of SIMPONI ARIA® (golimumab) for patients 2 years of age and older for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) and has extended the psoriatic arthritis (PsA) indication for this same patient population. This approval provides a new treatment option for patients with pediatric psoriatic arthritis (PsA), one of the rarest subtypes of juvenile idiopathic arthritis (JIA). [1]

SIMPONI ARIA®, manufactured by Janssen Pharmaceutical Companies of Johnson & Johnson, is an anti-tumor necrosis factor (TNF)-monoclonal antibody. It acts by inhibiting TNF-alpha, a protein that promotes inflammation, and thereby aims to limit inflammation in the body. [1]

“Juvenile idiopathic arthritis is the most common rheumatologic disease in children, and up to 7 percent of pediatric patients with JIA have PsA. Pediatric PsA can be particularly aggressive and cause irreversible damage. There are a limited number of treatments available, particularly for axial skeleton involvement. This option really changes things and gives providers an additional option, in a good way. It adds to what we can do, particularly with refractory disease,” says Dr. Ekemini A. Ogbu, assistant professor of pediatrics at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Pediatric Rheumatology Clinic.

This approval is based on findings from a Phase 3 clinical trial, GO-VIVA. GO-VIVA was an open-label study in children between the ages of 2 and 17 years, who had JIA with active polyarthritis despite treatment with methotrexate for at least 2 months. Findings from the clinical trial showed that pharmacokinetic exposure of SIMPONI ARIA was consistent with findings from two clinical trials in adult patients with moderate-to-severe active rheumatoid arthritis (RA) or active PsA. [1]

“Psoriatic arthritis can really impact the day-to-day activities for children, as well as their future goals. This is a chronic debilitating disease where acts such as waking up and getting out of bed or writing can become difficult. When children have refractory disease, it can be very challenging. So, it is helpful to have additional treatment options available for pediatric patients,” shares Dr. Ogbu. “The pediatric rheumatology community is very excited because we’re able to do more for our patients. Not too long ago, we were limited in therapeutic options for pediatric patients with PsA, but the availability of biologics has opened a new chapter. We are able to better control this disease, especially refractory cases. We can help children achieve their goals.”

SIMPONI ARIA® is also approved for the treatment adults with moderately to severe active RA, active PsA and active ankylosing spondylitis. [1]

 

Do you have questions about psoriatic disease treatment options? NPF’s Patient Navigation Center is available to anyone impacted by psoriatic disease to help answer questions and find solutions so you can live their healthiest life.

[1]. https://www.jnj.com/simponi-aria-golimumab-approved-by-the-u-s-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

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