Simponi Aria® Approved for Psoriatic Arthritis In Children 2 Years of Age and Older
The U.S. Food and Drug Administration (FDA) has approved Simponi Aria® (golimumab) for the treatment of active polyarticular juvenile idiopathic arthritis in people 2 years of age and older. The drug approval has also been extended for the treatment of psoriatic arthritis in the same age group.1
About 300,000 children in the United States have a form of juvenile idiopathic arthritis (JIA). The polyarticular form is the most common (pJIA). Children with this form of JIA have inflammation in more than 4 joints. Psoriatic arthritis (PsA) in children is rare. It can cause joint inflammation and skin lesions.1
Simponi Aria® is a biologic drug that contains the ingredient golimumab. It is a monoclonal antibody. Simponi Aria is known as a TNF (tumor necrosis factor) blocker. High levels of TNF can cause inflammation. By blocking TNF, drugs like Simponi Aria help certain conditions that cause inflammation, like rheumatoid arthritis and psoriatic arthritis.2
Simponi Aria was previously only approved for adults. A new study expands some of the approvals of Simponi Aria to children. Simponi Aria is now approved for:1
- Moderate to severe rheumatoid arthritis in adults (in combination with methotrexate)
- Active psoriatic arthritis in people 2 years and older
- Active ankylosing spondylitis in adults
- Active polyarticular juvenile idiopathic arthritis in people 2 years and older
Evidence for Simponi Aria in treating children
The new approval was based on results from a study called GO-VIVA. GO-VIVA is a Phase 3 study conducted across 9 countries. The study included 127 children with active pJIA who were also taking methotrexate. The study was designed to evaluate the dose of Simponi Aria in children that would lead to the same drug levels and exposure in adults.1
In the trial, children with pJIA took Simponi Aria. The results showed that the exposure to the medicine was consistent with that of adults (from previous adult trials). The drug was also as effective in children as it was in adults, and side effects were also consistent.1
Why is this an important approval?
About 33 percent of children with psoriasis will get psoriatic arthritis. Children with psoriatic arthritis have chronic joint inflammation and swelling. They are also at risk for inflammation of the eyes.3
Psoriatic arthritis symptoms can range anywhere from mild to severe. Symptoms may include a psoriasis skin rash, swelling, inflammation, stiffness, and nail peeling.3
Polyarticular juvenile idiopathic arthritis (pJIA) affects more than 4 joints, causing more challenges in treatment. Children with pJIA are at higher risk for joint damage. They have poorer outcomes and a lower quality of life.4
More treatment options are needed for both of these conditions, and this approval provides a new choice for children and their families.1
Things to think about
Simponi Aria can increase the risk of serious infections. These infections can lead to hospitalization or death. Infections can include tuberculosis and other bacterial, viral, or fungal infections.2 Simponi Aria can increase the chance of malignancies, such as lymphoma.2
There are other serious risks associated with Simponi Aria treatment. Simponi Aria is not right for everyone. Talk to your doctor about the risks and benefits of Simponi Aria, and whether it might be a good choice for you. Before taking Simponi Aria, tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
For more information, read the full prescribing information for Simponi Aria.
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