Simponi Aria Granted New and Expanded Arthritis Indications

September 30, 2020 – The U.S. FDA has approved a new indication for Simponi Aria® (golimumab), manufactured by Janssen Pharmaceutical, to treat active polyarticular juvenile idiopathic arthritis in patients who are at least two years old. The FDA has also approved an expansion of Simponi Aria’s active psoriatic arthritis (PsA) indication to includes patients in the same age group. Previously, Simponi Aria was restricted to use in adult patients for the treatment of PsA.

Juvenile idiopathic arthritis (JIA) is arthritis that occurs before the age of 16 and persists for at least six weeks. Polyarticular JIA (pJIA) is the most common subtype, while PsA is one of the rarest. Patients diagnosed with pJIA have inflammation in at least five different joints. PsA is characterized by joint inflammation accompanied by psoriatic skin lesions.

In a clinical study, Simponi Aria demonstrated similar safety and efficacy in pediatric patients compared to adults. Recommended dosing for pediatric patients is 80mg/m 2 of body surface area administered via intravenous infusion over the course of 30 minutes at weeks 0 and 4, then every eight weeks thereafter.

A black box warning cautions that there is a risk of serious infection associated with the use of Simponi Aria, and that potentially fatal lymphoma and other malignancies have been reported in children and adolescent patients treated with TNF blockers like Simponi Aria.

First FDA approved in 2009, Simponi Aria is also indicated to treat adults who have active ankylosing spondylitis or moderately to severely active rheumatoid arthritis.