WASHINGTON — The FDA approved golimumab for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA). It also extended its indication for active psoriatic arthritis (PsA) for patients age 2 years and older.
Golimumab, a fully human anti-tumor necrosis (TNF)-alpha biologic agent that is given via intravenous infusion, is the first of its class for use in both of these indications.
The Go-VIVA phase III open label study formed the basis for the approval. In the trial, children with pJIA age 2-17 with active arthritis in five or more joints that did not abate with methotrexate were treated with golimumab, with “pharmacokinetic exposure consistent with that of two pivotal phase III clinical trials… in adult patients with moderate to severe active [rheumatoid arthritis] RA and active PsA.” The drug’s efficacy was assessed over 52 weeks, and results were comparable to those seen in adults with RA. Adverse events seen in children were also consistent with those seen in 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,” said Daniel J. Lovell, of the Joseph E. Levinson Professor of Pediatric Rheumatology at Cincinnati Children’s Hospital Medical Center, in a statement about the approval. “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.”
Golimumab does carry a safety warning about serious infections, which includes the fact that it may lower a patient’s ability to fight infections. Serious infections caused by bacteria, fungi, or systemic viruses, included tuberculosis (TB) and histoplasmosis, have been reported, with some being fatal, Janssen explained on the prescribing insert. Physicians should test patients for TB prior to initiating golimumab treatment and patients are advised to tell their physicians if they have been in contact with people with TB or have been in regions where fungal infections, such as histoplasmosis or coccidioidomycosis, are common.
Janssen will market the drug as SIMPONI ARIA.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 158
Topic ID: 90,158,10,138,725,158,68,919
