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    Home > Active Ingredient News > Drugs Articles > FDA expands indications of golimub: new treatment of PSA or as

    FDA expands indications of golimub: new treatment of PSA or as

    • Last Update: 2017-10-30
    • Source: Internet
    • Author: User
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    Ankylosing spondylitis (as) is a common inflammatory joint disease, which can significantly affect the quality of life of patients, but the effective drugs are very limited The emergence of golimub brings new hope for patients Golimumab is a tumor necrosis factor (TNF) - α inhibitor It was approved by the US FDA (http:// in 2013 for the treatment of moderate and severe active rheumatoid arthritis (RA) Recently, FDA has expanded the indications of golimub and added the treatment of active psoriatic arthritis (PSA) or active ankylosing spondylitis (as) in adults The FDA approved the use of golimub in the treatment of PSA and as mainly based on two phase 3 studies (go-vibrant and go-alive Studies), involving more than 600 patients The go-vibrant study showed that after 14 weeks of treatment, the ACR 20 response rate of PSA patients in golimub group was significantly higher than that in placebo group (75% vs 22%, P < 0.001) After 24 weeks of treatment, the progress of structural joint injury was reduced and the function of PSA related body was improved The go-alive study showed that after 16 weeks of treatment, 73% of as patients in the golimub group had improved their spine assessment standard by more than 20% in the international community, while 26% in the placebo group (P < 0.001)
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