medwireNews: The US FDA has expanded the label for the tumor necrosis factor (TNF) inhibitor golimumab to include two pediatric indications.
Previously approved for the treatment of adult rheumatoid arthritis (RA) and ankylosing spondylitis, golimumab may now be given to patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis (pJIA) or active psoriatic arthritis (PsA).
The approval for pJIA was based on the results of the GO-VIVA trial, which demonstrated similar efficacy to that shown previously in RA patients, while the efficacy of golimumab in children with PsA was extrapolated from pharmacokinetic studies and the established efficacy in adults with PsA.
In pediatric patients, golimumab is given intravenously at a dose of 80 mg/m2 every 8 weeks, following initial loading doses at weeks 0 and 4. The label carries a boxed warning for lymphoma and other malignancies in children and adolescents treated with TNF inhibitors, as well as for serious infection risk.
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