A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study).
A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study).
复制标题
一项随机、双盲、平行组研究，比较皮下注射托珠单抗与静脉注射托珠单抗联合传统缓解病情抗风湿药物治疗中重度类风湿关节炎患者的安全性和有效性（SUMMACTA 研究）。
DOI：
10.1136/annrheumdis-2013-203523
复制
发表时间：
2014-01
影响因子：
27.4
通讯作者：
Mysler EF
中科院分区：
文献类型：
--
作者：
Burmester GR;Rubbert-Roth A;Cantagrel A;Hall S;Leszczynski P;Feldman D;Rangaraj MJ;Roane G;Ludivico C;Lu P;Rowell L;Bao M;Mysler EF
本研究比较了托珠单抗皮下（SC）与静脉（IV）制剂在对病情缓解抗风湿药物（DMARD）反应不足的类风湿关节炎患者中的疗效和安全性。患者（n=1262）被随机分配接受托珠单抗-SC 162 mg每周一次+安慰剂IV每4周一次或托珠单抗-IV 8 mg/kg每4周一次+安慰剂SC每周一次联合传统DMARD治疗。 主要结局是使用12%的非劣效性界值（NIM）证明托珠单抗-SC在第24周达到美国风湿病学会（ACR）20应答的患者比例方面非劣效于托珠单抗-IV。次要结局是使用28个关节（DAS 28）的疾病活动度评分、ACR应答、健康评估问卷评分和安全性评估。第24周时，69.4%（95% CI 65.5 - 73.2）的托珠单抗SC治疗患者与73.4%（95% CI 69.6 - 77.1）的托珠单抗IV治疗患者达到了ACR 20缓解（组间加权差− 4.0%，95% CI −9.2 - 1.2）;符合12% NIM。托珠单抗-SC和托珠单抗-IV组之间的ACR 50/70应答、DAS 28和身体功能改善相当。托珠单抗-SC和托珠单抗-IV的安全性特征相似，最常见的不良事件是感染。托珠单抗-SC组注射部位反应（ISR）的发生率高于托珠单抗-IV（安慰剂-SC）组。24周内未报告速发过敏反应。 托珠单抗-SC 162 mg每周一次显示出与托珠单抗-IV 8 mg/kg相当的疗效。 托珠单抗-SC的安全性特征与托珠单抗-IV的已知且已确立的安全性特征一致，但托珠单抗-SC给药更常见的ISR发生率较高。
This study compared the efficacy and safety of subcutaneous (SC) versus intravenous (IV) formulations of tocilizumab in patients with rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs (DMARD). Patients (n=1262) were randomly assigned to receive tocilizumab-SC 162 mg weekly+placebo-IV every 4 weeks or tocilizumab-IV 8 mg/kg every 4 weeks+placebo-SC weekly in combination with traditional DMARD. The primary outcome was to demonstrate the non-inferiority of tocilizumab-SC to tocilizumab-IV with regard to the proportion of patients in each group achieving an American College of Rheumatology (ACR) 20 response at week 24 using a 12% non-inferiority margin (NIM). Secondary outcomes were disease activity score using 28 joints (DAS28), ACR responses, health assessment questionnaire scores and safety assessments. At week 24, 69.4% (95% CI 65.5 to 73.2) of tocilizumab-SC-treated patients versus 73.4% (95% CI 69.6 to 77.1) of tocilizumab-IV-treated patients achieved an ACR20 response (weighted difference between groups −4.0%, 95% CI −9.2 to 1.2); the 12% NIM was met. ACR50/70 responses, DAS28 and physical function improvements were comparable between the tocilizumab-SC and tocilizumab-IV groups. The safety profiles of tocilizumab-SC and tocilizumab-IV were similar, and the most common adverse event was infection. Injection-site reactions (ISR) occurred more frequently in the tocilizumab-SC group than in the tocilizumab-IV (placebo-SC) group. No anaphylaxis was reported over the 24 weeks. Tocilizumab-SC 162 mg weekly demonstrated comparable efficacy to tocilizumab-IV 8 mg/kg. The safety profile of tocilizumab-SC is consistent with the known and well-established safety profile of tocilizumab-IV, with the exception of a higher incidence of ISR, which were more common with tocilizumab-SC administration.
登录
查看更多内容
Golimumab是一种通过每月皮下注射给予的肿瘤坏死因子{alpha}的人类抗体，尽管甲氨蝶呤疗法是活跃的类风湿关节炎：Go-Fornward研究。
影响因子：
27.4
作者：
Keystone EC;Genovese MC;Klareskog L;Hsia EC;Hall ST;Miranda PC;Pazdur J;Bae SC;Palmer W;Zrubek J;Wiekowski M;Visvanathan S;Wu Z;Rahman MU;GO-FORWARD Study
通讯作者：
GO-FORWARD Study
影响因子：
--
作者：
Kremer, Joel M.;Blanco, Ricardo;Fleischmann, Roy
通讯作者：
Fleischmann, Roy
影响因子：
168.9
作者：
Smolen, Josef S.;Beaulieu, Andre;Alten, Rieke
通讯作者：
Alten, Rieke
影响因子：
27.4
作者：
Emery P;Keystone E;Tony HP;Cantagrel A;van Vollenhoven R;Sanchez A;Alecock E;Lee J;Kremer J
通讯作者：
Kremer J
影响因子：
--
作者：
Genovese, Mark C.;McKay, James D.;Gomez-Rein, Juan J.
通讯作者：
Gomez-Rein, Juan J.