McLaughlin Maeve, Östör Andrew
Addenbrooke's Hospital, Rheumatology Research Unit , Box 204, Cambridge Biomedical Campus, Hills Road, Cambridge , UK.
Expert Opin Drug Saf. 2015 Mar;14(3):429-37. doi: 10.1517/14740338.2015.998198. Epub 2015 Jan 2.
Tocilizumab (TCZ), a humanized anti-IL-6 receptor (IL-6R) monoclonal antibody, has demonstrated efficacy and tolerability in several large randomized, controlled trials for the treatment of rheumatoid arthritis (RA).
This article compares the safety profile of the newer, subcutaneous (SC) formulation of TCZ with the original intravenous (IV) formulation, in combination with traditional disease-modifying antirheumatic drugs (DMARDs) in patients with RA. Several pivotal clinical trials are included, highlighting data from: i) trials of TCZ-IV; ii) trials of TCZ-SC; and iii) trials comparing IV to SC TCZ. TCZ use in pediatric populations is beyond the scope of this review.
The efficacy and safety of TCZ-IV in the treatment of RA has been demonstrated in multiple clinical trials, both as monotherapy and in combination with traditional DMARDs. The data for TCZ-SC is similar, albeit with a higher frequency of injection site reactions (ISRs). With careful patient selection, the benefit: risk ratio is favorable, offering patients a rapid and sustained reduction in disease activity, improved function and reduced structural damage. Given that most patients prefer SC to IV medication, TCZ-SC will likely become a mainstay, along with other biologic agents, for the treatment of RA patients who have failed traditional non-biologic DMARDs.
托珠单抗(TCZ)是一种人源化抗白细胞介素6受体(IL-6R)单克隆抗体,在多项治疗类风湿关节炎(RA)的大型随机对照试验中已证明其有效性和耐受性。
本文比较了TCZ新型皮下(SC)制剂与原始静脉注射(IV)制剂在RA患者中与传统改善病情抗风湿药物(DMARDs)联合使用时的安全性。纳入了多项关键临床试验,突出了以下数据:i)TCZ-IV试验;ii)TCZ-SC试验;iii)比较IV与SC TCZ的试验。TCZ在儿科人群中的应用不在本综述范围内。
TCZ-IV在治疗RA方面的有效性和安全性已在多项临床试验中得到证实,无论是作为单药治疗还是与传统DMARDs联合使用。TCZ-SC的数据与之相似,尽管注射部位反应(ISR)的发生率较高。通过仔细选择患者,其获益:风险比是有利的,能使患者的疾病活动迅速且持续降低,功能改善,结构损伤减少。鉴于大多数患者更喜欢皮下注射而非静脉注射药物,TCZ-SC可能会与其他生物制剂一起,成为治疗传统非生物DMARDs治疗失败的RA患者的主要药物。