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The FDA has approved Simponi Aria, Janssen Pharmaceuticals' intravenous formulation of the TNF-alpha inhibitor golimumab, for moderate to severe rheumatoid arthritis. This adds a new, quick-delivery option to the subcutaneous form already available.
The Food and Drug Administration has approved Janssen's Simponi Aria, an intravenous formulation of the tumor necrosis factor (TNF) inhibitor golimumab, to treat moderate to severe rheumatoid arthritis.
The only infusible fully human TNF-alpha inhibitor, Simponi Aria has been shown to achieve significant mprovement in RA symptoms and physical function and to inhibit progression. According to Janssen, the approval is based on phase III resutls of the placebo-controlled GO-FURTHER trial, which involved 592 RA patients with RA who had at least six tender and six swollen joints, elevated CRP at screening, and who had been taking methotrexate for at least three months.
Among patients who received the drug plus methotrexate, 59% achieved symptom improvements in the ACR20 measure within as little as two weeks, while only 25% of those given placebo plus methotrexate showed this degree of improvement.
The treatment also inhibited progression. The change from baseline in radiographic joint scores was 0.03 in the treatment arm and and 1.09 in the placebo group.
Simponi Aria is infused intravenously at a dose of 2 mg/kg at weeks 0 and 4, then every 8 weeks thereafter. Golimumab was approved in 2009 as a once-monthly subcutaneous treatment for moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.