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Drugs. 2017 Apr;77(6):705-712. doi: 10.1007/s40265-017-0724-2.
Sarilumab (Kevzara™) is a fully human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound interleukin (IL)-6 receptors (sIL-6Rα and mIL-6Rα) and thereby inhibits IL-6-mediated signalling through these receptors. Subcutaneous sarilumab is approved in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more biological or non-biological disease-modifying anti-rheumatic drugs. It is under regulatory review for use in rheumatoid arthritis in other countries, including in the EU, USA and Japan. Sarilumab is also under phase II investigation for the treatment of juvenile idiopathic arthritis. This article summarizes the milestones in the development of sarilumab leading to its first global approval for the treatment of rheumatoid arthritis.
瑟利珠单抗（Kevzara™）是一种全人源 IgG1 单克隆抗体，可特异性结合可溶性和膜结合白细胞介素 (IL)-6 受体（sIL-6Rα 和 mIL-6Rα），从而抑制这些受体介导的 IL-6 信号转导。皮下注射用瑟利珠单抗在加拿大获批用于治疗对一种或多种生物或非生物疾病修饰抗风湿药物反应不足的中重度活跃性类风湿关节炎成年患者。该药正在其他国家（包括欧盟、美国和日本）监管审查中，以用于治疗类风湿关节炎。瑟利珠单抗也正在进行 II 期临床试验，以治疗幼年特发性关节炎。本文总结了瑟利珠单抗的开发里程碑，最终该药在全球范围内获批用于治疗类风湿关节炎。
