Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
Drugs. 2017 Nov;77(17):1865-1879. doi: 10.1007/s40265-017-0829-7.
Intravenous (IV) and subcutaneous (SC) tocilizumab (RoActemra), an IL-6 receptor antagonist, are approved (± methotrexate) in numerous countries throughout the world, for the treatment of adults with moderate to severe active rheumatoid arthritis (RA). Extensive clinical experience has firmly established the short- and long-term efficacy and safety of tocilizumab [monotherapy or in combination with conventional synthetic DMARDs (csDMARDs)] in adults with early-stage and longer-duration established RA. In the clinical trial and real-world settings, tocilizumab monotherapy or combination therapy provided rapid and sustained improvements in clinical and radiographic outcomes and health-related quality of life. The safety profile of tocilizumab is consistent over time and, in general, is consistent with that of other immunomodulatory agents. This narrative review, written from an EU perspective, summarizes the clinical use of IV and SC tocilizumab in RA. Given its low risk of immunogenicity, the flexibility of IV and SC administration and the convenience of the once-weekly, self-administered, SC regimen, tocilizumab provides an effective treatment for severe, active and progressive RA in adults not previously treated with methotrexate and an effective biologic first- or subsequent-line treatment for moderate to severe active RA in adults who have either responded inadequately to or were intolerant of previous therapy with ≥ 1 csDMARD or TNF inhibitor.
静脉注射(IV)和皮下注射(SC)托珠单抗(罗美昔单抗),一种白细胞介素 6 受体拮抗剂,在全球许多国家已被批准(联合或不联合甲氨蝶呤)用于治疗成人中重度活动性类风湿关节炎(RA)。大量的临床经验证实了托珠单抗在治疗早期和病程较长的中重度 RA 成人患者中的短期和长期疗效和安全性[单药或联合传统合成改善病情抗风湿药(csDMARDs)]。在临床试验和真实世界环境中,托珠单抗单药或联合治疗可迅速且持续改善临床和影像学结局以及健康相关生活质量。托珠单抗的安全性特征在时间上保持一致,并且通常与其他免疫调节剂一致。这篇从欧盟角度撰写的叙述性综述总结了 RA 中 IV 和 SC 托珠单抗的临床应用。鉴于其低免疫原性风险、IV 和 SC 给药的灵活性以及每周一次、自我给药的 SC 方案的便利性,托珠单抗为未接受过甲氨蝶呤治疗的重度、活动期和进展性 RA 成人提供了一种有效的治疗选择,并且为那些对先前的 ≥1 种 csDMARD 或 TNF 抑制剂治疗反应不足或不耐受的中重度活动性 RA 成人提供了一种有效的生物制剂一线或二线治疗选择。