The U.S. Food and Drug Administration (FDA) has approved Janssen‘s Simponi Aria (golimumab) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA) in individuals ages 2 or older.
“This latest FDA approval of SIMPONI ARIA for pediatric use in active pJIA and active PsA 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,” Mathai Mammen, MD, PhD, global head of Janssen Research & Development, Johnson & Johnson, said in a press release.
Simponi Aria is an antibody that works by blocking tumor necrosis factor alpha (TNF-alpha), a signaling molecule that increases inflammation. By blocking TNF-alpha, the medication is designed to reduce inflammation and, in doing so, decrease pain and damage in the joints.
The therapy is administered by an intravenous (into-the-vein) infusion, which takes about a half-hour. Starter doses are given four weeks apart, after which infusions are done every eight weeks.
According to Janssen, Simponi Aria is the first and only fully human anti-TNF-alpha biologic agent administered by intravenous infusion to be approved for pediatric use in both active pJIA and jPsA. The medication has previously been approved by the FDA for psoriatic arthritis in adults, ankylosing spondylitis, and rheumatoid arthritis (in combination with methotrexate).
“For more than 20 years, we at Janssen have been committed to researching anti-TNF biologic agents for immune-mediated diseases and are encouraged to expand treatment options for these patients,” Mammen said.
The new approval was based on data from the Phase 3 clinical trial GO-VIVA (NCT02277444), sponsored by Janssen. This trial evaluated 127 children ages 2 to 17 with pJIA or jPsA who had active disease despite at least two months of treatment with methotrexate. Participants were treated with Simponi Aria for one year.
Because of the limited number of available JIA patients, data from this study were compared with findings from trials of Simponi Aria in adults with similar conditions: pJIA data were compared with results in adults with rheumatoid arthritis from the Phase 3 trial GO-FURTHER (NCT00973479), while jPsA data were compared with data from the Phase 3 study GO-VIBRANT (NCT02181673), which evaluated the medication in adults with psoriatic arthritis.
Results indicated that the safety and effectiveness of Simponi Aria were similar between children and adults.
“Due to the limited availability of pediatric patients for inclusion in clinical trials, it can be challenging to build clinical studies for this young patient population. Given these challenges, I am pleased to see Janssen advance the approval of a new treatment option for pediatric patients with pJIA and PsA — an important milestone in the treatment of these complex, heterogeneous diseases,” said Daniel J. Lovell, MD, a professor at Cincinnati Children’s Hospital Medical Center.
Janssen is offering a support program called CarePath, which provides information on insurance coverage, potential out-of-pocket costs, and treatment support, to identify options that can make the newly approved medication more affordable.
“For far too long, children with pJIA or PsA have had limited treatment options,” said Seth D. Ginsberg, co-founder and president of the Global Healthy Living Foundation and CreakyJoints. “This approval represents an important step forward for these children and their families.”
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