Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study.
Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study.
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DOI：
10.1136/ard.2008.092866
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发表时间：
2009-10
影响因子：
27.4
通讯作者：
Azuma J
中科院分区：
文献类型：
--
作者：
Nishimoto N;Miyasaka N;Yamamoto K;Kawai S;Takeuchi T;Azuma J
评估5年长期托珠单抗单药治疗类风湿关节炎患者的安全性和有效性。在一项为期3个月的初始随机II期试验之后的开放标签长期扩展试验中，163名参加初始盲法研究的患者中有143名每4周接受tocilizumab单药治疗（8mg /kg）。允许同时使用非甾体抗炎药和/或口服强的松龙（每日最大10mg）。所有患者均采用美国风湿病学会（ACR）改善标准、28个关节的疾病活动度评分（DAS）、欧洲抗风湿病联盟反应以及安全性问题进行评估。143名患者参加了开放标签的长期扩展试验，截至2007年3月，94名（66%）患者完成了5年的治疗。32例（22%）患者因不良事件退出研究，1例（0.7%）患者因反应不理想退出研究。14例因患者要求或其他原因退出。根据tocilizumab总暴露量612患者年计算，严重不良事件发生率为每100患者年27.5次，每100患者年5.7次严重感染。在基线接受皮质类固醇治疗的88例患者中，78例（88.6%）能够减少皮质类固醇剂量，28例（31.8%）停止使用皮质类固醇。5年时，分别有79/94（84.0%）、65/94（69.1%）和41/94（43.6%）的患者达到了ACR20、ACR50和ACR70的改善标准。52/94（55.3%）的患者达到DAS28小于2.6的缓解。在这项为期5年的扩展研究中，托珠单抗显示出持续的长期疗效和总体良好的安全性。
To evaluate the safety and efficacy of 5-year, long-term tocilizumab monotherapy for patients with rheumatoid arthritis. In an open-label, long-term extension trial following an initial 3-month randomised phase II trial, 143 of the 163 patients who participated in the initial blinded study received tocilizumab monotherapy (8 mg/kg) every 4 weeks. Concomitant therapy with non-steroidal anti-inflammatory drugs and/or oral prednisolone (10 mg daily maximum) was permitted. All patients were evaluated with American College of Rheumatology (ACR) improvement criteria, disease activity score (DAS) in 28 joints, and the European League Against Rheumatism response, as well as for safety issues. 143 patients were enrolled in the open-label, long-term extension trial and 94 (66%) patients had completed 5 years as of March 2007. 32 patients (22%) withdrew from the study due to adverse events and one patient (0.7%) due to unsatisfactory response. 14 patients withdrew because of the patient’s request or other reasons. The serious adverse event rate was 27.5 events per 100 patient-years, with 5.7 serious infections per 100 patient-years, based on a total tocilizumab exposure of 612 patient-years. Of the 88 patients receiving corticosteroids at baseline, 78 (88.6%) were able to decrease their corticosteroid dose and 28 (31.8%) discontinued corticosteroids. At 5 years, 79/94 (84.0%), 65/94 (69.1%) and 41/94 (43.6%) of the patients achieved ACR20, ACR50, and ACR70 improvement criteria, respectively. Remission defined as DAS28 less than 2.6 was achieved in 52/94 (55.3%) of the patients. In this 5-year extension study, tocilizumab demonstrated sustained long-term efficacy and a generally good safety profile.
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影响因子：
27.4
作者：
Nishimoto, N;Kishimoto, T;Yoshizaki, K
通讯作者：
Yoshizaki, K
影响因子：
27.4
作者：
Weinblatt, M. E.;Keystone, E. C.;Segurado, O. G.
通讯作者：
Segurado, O. G.
影响因子：
168.9
作者：
Klareskog, L;van der Heijde, D;Sanda, M
通讯作者：
Sanda, M
影响因子：
--
作者：
Breedveld, FC;Weisman, MH;Spencer-Green, GT
通讯作者：
Spencer-Green, GT
影响因子：
--
作者：
Choy, EHS;Isenberg, DA;Panayi, GS
通讯作者：
Panayi, GS