Golimumab Approved for Pediatric Forms of Juvenile Arthritis and Psoriatic Arthritis

(©Sebastian, AdobeStock.com)

Golimumab (Simponi Aria, Janssen/J&J) has been approved by the U.S. Food and Drug Administration for two pediatric conditions:active pediatric juvenile idiopathic arthritis (JIA) and active pediatric psoriatic arthritis.

The approval, which was announced by Janssen Pharmaceutical Companies of Johnson & Johnson on Wednesday, was based on results from the GO-VIVA phase 3 clinical trial, an open-label clinical trial in children between two and 17 years old with juvenile arthritis with active polyarthritis. The study participants had to have had arthritis in five or more joints and had previously been treated with methotrexate for at least two months.

The findings demonstrated that golimumab was consistent with that of two pivotal phase 3 clinical trials of golimumab in adult patients with moderately to severely active rheumatoid arthritis and active psoriatic arthritis. The efficacy and adverse reactions were consistent with the safety profiles adults with rheumatoid arthritis and psoriatic arthritis. ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​

GO-VIVA is a phase 3, open-label, single arm, multicenter study conducted across nine countries with treatment received by 127 patients with JIA with active polyarthritis, despite current treatment with methotrexate. GO-VIVA was conducted as a post-marketing requirement under the Pediatric Research Equity Act (PREA) following the initial approval of golimumab for adults with moderately to severely active rheumatoid arthritis in 2013.

GO-VIVA was designed to evaluate the dosing of golimumab in children that is required to achieve drug levels and exposures that are similar to those that were shown to be safe and effective in adults with moderately to severely active rheumatoid arthritis, since active pJIA, active psoriatic arthritis in pediatric patients, and adult rheumatoid arthritis show similarities in disease.

Golimumab, a fully human anti-TNF-alpha monoclonal antibody, is also approved to treat adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.