Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study).
Efficacy and tolerability of tocilizumab in rheumatoid arthritis patients seen in daily clinical practice in Japan: results from a retrospective study (REACTION study).
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DOI：
10.1007/s10165-010-0366-7
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发表时间：
2011-04
影响因子：
2.2
通讯作者：
Takeuchi, Tsutomu
中科院分区：
文献类型：
--
作者：
Yamanaka, Hisashi;Tanaka, Yoshiya;Inoue, Eisuke;Hoshi, Daisuke;Momohara, Shigeki;Hanami, Kentaro;Yunoue, Naoki;Saito, Kazuyoshi;Amano, Kouichi;Kameda, Hideto;Takeuchi, Tsutomu
Tocilizumab是一种针对白细胞介素6 （IL-6）受体的人源化单克隆抗体，于2008年在日本被批准用于类风湿性关节炎（RA）的治疗，但其在日常实践中的疗效和耐受性尚未报道。我们报告了一项多中心回顾性研究tocilizumab疗效和安全性的结果，该研究涉及2008年4月至2009年3月在日本三家风湿病研究所开始接受tocilizumab治疗的所有患者（n = 229）。Tocilizumab根据药物标签以8mg /kg的剂量每4周输注一次。在229例患者中，55%的患者同时接受了甲氨蝶呤（MTX）治疗，63%的患者先前接受过抗肿瘤坏死因子（TNF）治疗。治疗24周后，229例患者的平均疾病活动评分（DAS） 28从5.70降至3.25。24周时，欧洲抗风湿病联盟（EULAR）的良好反应和DAS28缓解分别为57.4%和40.7%。白细胞计数显著降低，肝酶和总胆固醇略有升高，但显著升高；然而，没有服用甲氨蝶呤的患者肝酶水平没有升高。47例（20.5%）Tocilizumab因缺乏疗效（5.2%）、不良事件（11.4%）和其他原因（3.9%）而停药。24周的总保留率为79.5%。基于这些结果，我们得出结论，tocilizumab治疗在日常风湿病实践中似乎对活动性RA患者（包括抗tnf治疗难治性人群）非常有效且耐受性良好。因此，Tocilizumab输注不仅可作为抗tnf治疗耐药患者的替代方法，也可作为活动期RA患者的主要生物治疗方法。
Tocilizumab, a humanized monoclonal antibody to the interleukin 6 (IL-6) receptor, was approved for use as rheumatoid arthritis (RA) therapy in Japan in 2008, but its efficacy and tolerability in daily practice has not yet been reported. We report the results of a multicenter retrospective study on the efficacy and safety of tocilizumab involving all patients (n = 229) who were started on tocilizumab therapy at three rheumatology institutes in Japan from April 2008 through to March 2009. Tocilizumab was infused every 4 weeks at a dose of 8 mg/kg according to the drug labeling. Among the 229 patients, 55% concomitantly received methotrexate (MTX) and 63% had previously received anti-tumor necrosis factor (TNF) therapy. Average disease activity score (DAS) 28 of all 229 patients significantly decreased from 5.70 to 3.25 after 24 weeks of therapy. A European League Against Rheumatism (EULAR) good response and DAS28 remission was achieved in 57.4 and 40.7% of the patients, respectively, at 24 weeks. White blood cell counts significantly decreased and liver enzymes and total cholesterol slightly but significantly increased; however, liver enzyme levels did not increase in patients without MTX. Tocilizumab was discontinued in 47 cases (20.5%) due to lack of efficacy (5.2%), adverse events (11.4%), and other reasons (3.9%). The overall retention rate at 24 weeks was 79.5%. Based on these results, we conclude that tocilizumab therapy in daily rheumatology practice appears to be highly efficacious and well tolerated among active RA patients, including the anti-TNF therapy-refractory population. Tocilizumab infusion is therefore applicable not only as an alternative approach for anti-TNF therapy-resistant patients, but also as primary biologic therapy for active RA patients.
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