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Subcutaneous formulation of tocilizumab for treatment of rheumatoid arthritis

机译:托珠单抗皮下制剂治疗类风湿关节炎

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摘要

Tocilizumab (TCZ) is a humanized monoclonal antibody against the IL-6 receptor that is indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis and Castleman's disease. TCZ was developed as an intravenous (IV) formulation and approved for RA treatment in Japan (2008), the EU (2009) and the USA (2010). Recently, a subcutaneous (SC) formulation of TCZ was developed and approved for RA treatment. Efficacy and safety of TCZ-SC were reported through three randomized trials: MUSASHI, SUMMACTA and BREVACTA. Clinical efficacy and overall safety of TCZ-SC was comparable to that of TCZ-IV. However TCZ-SC, which is provided in a fixed dose, the efficacy was affected by patient weight. The frequencies of injection site reactions and anti-TCZ antibodies were increased with TCZ-SC compared with TCZ-IV, although differences were minimal and at a negligible level for daily clinical practice. This review highlights the potential of TCZ-SC in RA treatment.
机译:Tocilizumab(TCZ)是针对IL-6受体的人源化单克隆抗体,被指定用于治疗类风湿关节炎(RA),青少年特发性关节炎和Castleman病。 TCZ是作为静脉(IV)制剂开发的,并已在日本(2008),欧盟(2009)和美国(2010)批准用于RA治疗。最近,开发了TCZ的皮下(SC)制剂并批准用于RA治疗。 TCZ-SC的疗效和安全性通过三项随机试验报告:MUSASHI,SUMMACTA和BREVACTA。 TCZ-SC的临床疗效和总体安全性与TCZ-IV相当。但是,以固定剂量提供的TCZ-SC,疗效受患者体重的影响。与TCZ-IV相比,TCZ-SC可以增加注射部位反应和抗TCZ抗体的频率,尽管差异很小并且在日常临床实践中可以忽略不计。这篇综述强调了TCZ-SC在RA治疗中的潜力。

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