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Tocilizumab for the treatment of rheumatoid arthritis

机译:托珠单抗治疗类风湿关节炎

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摘要

Tocilizumab (TCZ) is a humanized monoclonal antibody against the IL-6 receptor, approved in Japan, Europe and the USA for the treatment of severe rheumatoid arthritis. Several Phase III trials have shown a clinical efficacy of TCZ, such as in treatment of rheumatoid arthritis patients with no previous methotrexate failures both in combination with methotrexate and in monotherapy (the AMBITION trial); and rheumatoid arthritis patients who are resistant to disease-modifying antirheumatic drugs (the TOWARD, OPTION and LITHE trials) and anti-TNF-α agents (the RADIATE trial). Some of these Phase III trials have also demonstrated the radiologic efficacy of TCZ (the LITHE and SAMURAI trials) as well as its good safety profile, similar to other biologic agents. The effectiveness and safety of TCZ in a setting closer to clinical practice than that typically described in Phase III studies have recently been revealed by some Phase IIIb studies (the TAMARA, ROSE, ACT-SURE, ACT-RAY and ACT STAR studies) and the nationwide Danish registry.
机译:托珠单抗(TCZ)是针对IL-6受体的人源化单克隆抗体,已在日本,欧洲和美国批准用于治疗严重的类风湿关节炎。几项III期试验显示了TCZ的临床疗效,例如在既往没有甲氨蝶呤治疗失败的类风湿性关节炎患者中,结合甲氨蝶呤和单一疗法(AMBITION试验);对类风湿性关节炎和风湿性关节炎患者具有抗病药(TOWARD,OPTION和LITHE试验)和抗TNF-α药物(RADIATE试验)。这些III期试验中的某些试验还证明了TCZ的放射线有效性(LITHE和SAMURAI试验)以及与其他生物制剂相似的良好安全性。最近,一些IIIb期研究(TAMARA,ROSE,ACT-SURE,ACT-RAY和ACT STAR研究)揭示了TCZ在比III期研究通常更接近临床实践的环境中的有效性和安全性。丹麦全国注册。

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