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首页> 外文期刊>Modern rheumatology >Safety and efficacy profiles of tocilizumab monotherapy in Japanese patients with rheumatoid arthritis: meta-analysis of six initial trials and five long-term extensions.
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Safety and efficacy profiles of tocilizumab monotherapy in Japanese patients with rheumatoid arthritis: meta-analysis of six initial trials and five long-term extensions.

机译：在日本类风湿关节炎患者中使用Tocilizumab单药治疗的安全性和有效性概况：六项初步试验和五项长期扩展的荟萃分析。

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摘要

We present safety and efficacy data from Japanese clinical studies on monotherapy with tocilizumab (TCZ), a humanized anti-interleukin 6 receptor monoclonal antibody, in which 601 patients with moderate to severe rheumatoid arthritis, with a total of 2188 patient-years (pt-yr) exposure, were enrolled. The median treatment duration was 3.8 years. The incidence of adverse events (AEs), including abnormal laboratory test results, was calculated as 465.1 per 100 pt-yr. The most common serious adverse events (SAEs) were infections (6.22 per 100 pt-yr). There was no increase in the frequency of AEs or SAEs with long-term treatment. Abnormalities in the laboratory test results, such as increases in lipid parameters or abnormal liver function parameters, were common, but most were mild and there were no SAEs related to them. At baseline, 546 patients (90.8%) were taking corticosteroids; of these, 77.8% were able to decrease their corticosteroid dose during the study period, while 35.2% discontinued corticosteroids altogether. In the patients treated longer than 5 years, 91.3, 73.0, and 51.3% met the ACR20, ACR50, and ACR70 response criteria, respectively, and 59.7% met the DAS remission criterion (DAS28 <2.6) at 5 years. In conclusion, based on these results, TCZ has shown good tolerability and high efficacy during long-term treatment.
机译：我们提供了来自日本临床研究有关托西珠单抗（TCZ）（一种人源化抗白介素6受体单克隆抗体）的单一疗法的安全性和有效性数据，其中601例中度至重度类风湿性关节炎患者共2188病人年（pt- yr）暴露，被纳入。中位治疗时间为3.8年。不良事件（AEs）的发生率，包括异常的实验室测试结果，经计算为每100 pt-yr为465.1。最常见的严重不良事件（SAE）是感染（6.22 / 100 pt-yr）。长期治疗后，AE或SAE的发生率没有增加。实验室检查结果异常，如血脂参数增加或肝功能参数异常，是常见的，但大多数是轻度的，没有与之相关的SAE。基线时，有546名患者（占90.8％）正在服用皮质类固醇。其中，有77.8％的人能够在研究期间减少皮质类固醇的剂量，而35.2％的人完全停用了皮质类固醇。在治疗时间超过5年的患者中，分别满足ACR20，ACR50和ACR70响应标准的91.3、73.0和51.3％，以及满足5年DAS缓解标准（DAS28 <2.6）的59.7％。总之，基于这些结果，TCZ在长期治疗中显示出良好的耐受性和高疗效。

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