2 Pediatric Indications Sought for Golimumab

In late April, the U.S. Food & Drug Administration (FDA) received two supplemental Biologics License Applications for golimumab (Simponi Aria): one for treating polyarticular juvenile idiopathic arthritis (pJIA) and one for treating juvenile psoriatic arthritis (PsA). The tumor necrosis factor alpha (TNFα) inhibitor could to be used in combination with methotrexate to treat patients aged 2 years and older.

If the FDA approves both indications, golimumab will be the first intravenous TNFα antagonist available for treating children with arthritis.¹

Background
Data for both applications came from the phase 3 GO-VIVA clinical trial—a single-arm, multicenter, multi-nation study. The open-label study assessed golimumab’s pharmacokinetics, efficacy and safety in pJIA patients aged 2–17 with active arthritis in at least five joints despite methotrexate use for at least two months. The trial also included patients with juvenile PsA.

During the study, 127 patients with active pJIA despite methotrexate use were treated with golimumab. To determine golimumab’s potential efficacy and tolerability in pediatric patients, the study extrapolated data from a phase 3 clinical development program for golimumab in adults with rheumatoid arthritis (RA).

In 2013, golimumab was approved by the FDA for the treatment of adults with moderate to severe, active RA. The GO-VIVA study was conducted as a post-marketing, FDA requirement under the Pediatric Research Equity Act. 

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

Reference

1. Janssen Pharmaceutical Co. News release: Janssen announces submission of two applications to U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis. 2020 Apr 24.