Oldfield Vicki, Dhillon Sohita, Plosker Greg L
Wolters Kluwer Health, Auckland, New Zealand.
Drugs. 2009;69(5):609-32. doi: 10.2165/00003495-200969050-00007.
Tocilizumab (RoActemra or Actemra) is a recombinant humanized monoclonal antibody that acts as an interleukin (IL)-6 receptor antagonist. Intravenous tocilizumab 8 mg/kg (and no less than 4.8 mg), in combination with methotrexate, is approved in the EU for the treatment of moderate to severe active rheumatoid arthritis in adult patients with inadequate response to, or who are intolerant of, prior disease-modifying anti-rheumatic drug (DMARD) or tumour necrosis factor (TNF) antagonist therapy. It may also be administered as monotherapy in patients intolerant of methotrexate or in whom methotrexate therapy is inappropriate. Tocilizumab is also approved in Japan for the treatment of polyarticular-course juvenile idiopathic arthritis, systemic-onset juvenile idiopathic arthritis and Castleman's disease. Intravenous tocilizumab was effective and generally well tolerated when administered either as monotherapy or in combination with conventional DMARDs in several well designed clinical studies in adult patients with moderate to severe rheumatoid arthritis. Tocilizumab-based therapy was consistently more effective than placebo, methotrexate or other DMARDs in reducing disease activity, and some trials also showed significant benefits with tocilizumab in terms of reducing structural joint damage and improving health-related quality of life (HR-QOL). Notably, tocilizumab-based therapy was effective in patients with long-standing disease in whom anti-TNF therapy had previously failed. More data are required to determine the comparative efficacy and safety of tocilizumab versus other biological agents and to establish their relative cost effectiveness. However, the present data suggest that tocilizumab is an important emerging treatment option in adult patients with moderate to severe rheumatoid arthritis.
托珠单抗(RoActemra或Actemra)是一种重组人源化单克隆抗体,作为一种白细胞介素(IL)-6受体拮抗剂发挥作用。在欧盟,静脉注射8mg/kg(不少于4.8mg)托珠单抗联合甲氨蝶呤,被批准用于治疗对先前疾病修饰抗风湿药物(DMARD)或肿瘤坏死因子(TNF)拮抗剂治疗反应不足或不耐受的成年中重度活动性类风湿关节炎患者。对于不耐受甲氨蝶呤或甲氨蝶呤治疗不适用的患者,也可将其作为单一疗法给药。托珠单抗在日本也被批准用于治疗多关节型幼年特发性关节炎、全身型幼年特发性关节炎和Castleman病。在多项针对成年中重度类风湿关节炎患者的精心设计的临床研究中,静脉注射托珠单抗作为单一疗法或与传统DMARD联合使用时均有效且总体耐受性良好。在降低疾病活动度方面,基于托珠单抗的治疗始终比安慰剂、甲氨蝶呤或其他DMARD更有效,一些试验还显示托珠单抗在减少关节结构损伤和改善健康相关生活质量(HR-QOL)方面有显著益处。值得注意的是,基于托珠单抗的治疗在抗TNF治疗先前失败的长期患病患者中有效。需要更多数据来确定托珠单抗与其他生物制剂相比的疗效和安全性,并确定它们的相对成本效益。然而,目前的数据表明,托珠单抗是成年中重度类风湿关节炎患者中一种重要的新兴治疗选择。