Recently, the Janssen Pharmaceutical Companies of Johnson & Johnson (“Janssen”) announced the FDA approval of Simponi Aria (golimumab). The therapy is designed to treat pediatric patients (ages 2 or older) with forms of juvenile arthritis: polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA). Prior to Simponi Aria, there were few treatments designed for patients with these subtypes.
Currently, Simponi Aria is indicated for the treatment of adult patients with psoriatic arthritis, ankylosing spondylitis (AS), and moderate to severe rheumatoid arthritis. However, it now presents a more accessible treatment option for patients with pJIA and jPsA. The therapy is an intravenously administered anti-TNF-alpha antibody. Tumor necrosis factor alpha (TNF-alpha) is a pro-inflammatory cytokine. By blocking or inhibiting TNF-alpha, Simponi Aria reduces joint pain and inflammation. At first, patients are dosed every month. However, in time, this will progress to every 2 months.
The FDA approved Simponi Aria using data from the Phase 3 GO-VIVA clinical trial. 127 children (2-17) with jPsA or pJIA enrolled. Despite using methotrexate, all 127 children still had active disease states. The drug was found to be safe, effective, and well-tolerated. Admittedly, the study did not have a large number of patients with pJIA. As a result, researchers compared findings to adult patients with rheumatoid arthritis (RA).
Interested in learning more about Simponi Aria? Check out Janssen’s CarePath for information on out-of-pocket costs, treatment support, and insurance.
Juvenile Arthritis (pJIA & jPsA)
At its core, juvenile idiopathic arthritis (JIA) is a form of juvenile arthritis of unknown origin. It causes joint inflammation and stiffness. There are multiple forms of JIA, including oligoarticular, systemic, undifferentiated, psoriatic, enthesitis-related, and polyarticular. JIA is usually considered an autoimmune disorder, meaning the body mistakenly attacks its own joints.
Although there are many forms of JIA, many share symptoms. Symptoms often appear in the morning, but can occur any time. Patients may go through symptomatic periods, followed by remission. Symptoms include:
- Joint inflammation and pain
- Swollen lymph nodes
- Finger and toe swelling
- Skin rashes
- Uveitis and iritis (ocular inflammation)
As discussed, Simponi Aria is designed to treat polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis. In the first form (polyarticular), four or more joints are affected within the first six months. The second, juvenile psoriatic arthritis (jPsA), may go hand-in-hand with psoriasis, a type of skin disorder. In addition to the symptoms listed, children with jPsA will develop red, scaly patches of skin. The scales may be silver or white in color.