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首页> 外文期刊>Modern rheumatology >Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibit
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Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibit

机译：对甲氨蝶呤（SATORI）反应不足的类风湿关节炎患者的主动控制性tocilizumab单一疗法的研究：IL-6受体抑制显着降低疾病活动性和血清血管内皮生长因子

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摘要

We investigated the clinical efficacy and safety of tocilizumab (a humanized anti-IL-6 receptor antibody) monotherapy in active rheumatoid arthritis (RA) patients with an inadequate response to low dose methotrexate (MTX). In a multicenter, double-blind, randomized, controlled trial, 125 patients were allocated to receive either tocilizumab 8 mg/kg every 4 weeks plus MTX placebo (tocilizumab group) or tocilizumab placebo plus MTX 8 mg/week (control group) for 24 weeks. The clinical responses were measured using the American College of Rheumatology (ACR) criteria and the Disease Activity Score in 28 joints. Serum vascular endothelial growth factor (VEGF) levels were also monitored. At week 24, 25.0% in the control group and 80.3% in the tocilizumab group achieved ACR20 response. The tocilizumab group showed superior ACR response criteria over control at all time points. Additionally, serum VEGF levels were significantly decreased by tocilizumab treatment. The overall incidences of adverse events (AEs) were 72 and 92% (serious AEs: 4.7 and 6.6%; serious infections: 1.6 and 3.3%) in the control and the tocilizumab groups, respectively. All serious adverse events improved by adequate treatment. Tocilizumab monotherapy was well tolerated and provided an excellent clinical benefit in active RA patients with an inadequate response to low dose MTX.
机译：我们调查了对低剂量甲氨蝶呤（MTX）反应不足的活动性类风湿关节炎（RA）患者中Tocilizumab（人源化抗IL-6受体抗体）单一疗法的临床疗效和安全性。在一项多中心，双盲，随机，对照试验中，将125例患者分配为每4周接受Tocilizumab 8 mg / kg加MTX安慰剂（tocilizumab组）或Tocilizumab安慰剂加MTX 8 mg /每周（对照组），共24天周。使用美国风湿病学会（ACR）标准和28个关节的疾病活动评分来衡量临床反应。还监测了血清血管内皮生长因子（VEGF）水平。在第24周，对照组的25.0％和托珠单抗组的80.3％达到了ACR20反应。托珠单抗组在所有时间点均显示优于对照的ACR应答标准。另外，托珠单抗治疗可显着降低血清VEGF水平。对照组和托珠单抗组的不良事件（AE）总发生率分别为72％和92％（严重AE：4.7％和6.6％;严重感染：1.6％和3.3％）。适当的治疗可以改善所有严重的不良事件。 Tocilizumab单药治疗耐受性良好，并且在对低剂量MTX反应不足的活跃RA患者中提供了出色的临床益处。

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