medwireNews: The US FDA has expanded the indications for the tumor necrosis factor inhibitor golimumab to include psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
Intravenous golimumab was granted marketing authorization in 2009 for the treatment of moderate-to-severe rheumatoid arthritis in adult patients, and may now also be used for the treatment of adults with active PsA or AS.
These approvals are based on the results of the GO-VIBRANT trial, which found that a significantly greater proportion of PsA patients who were treated with golimumab achieved at least a 20% improvement in ACR criteria (ACR20) compared with those receiving placebo, and the GO-ALIVE trial, in which golimumab-treated AS patients were significantly more likely to experience at least a 20% improvement in Assessment in Ankylosing Spondylitis (ASAS) scores at week 16 than placebo-treated patients.
The FDA recommends that intravenous golimumab should be given as a 30-minute minute infusion at a dose of 2 mg/kg at weeks 0 and 4, then every 8 weeks, and the label carries a boxed warning highlighting the risk for serious infection and malignancy.
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