Osaka University Graduate School of Medicine, Osaka, Japan.
Mod Rheumatol. 2011 Feb;21(1):10-5. doi: 10.1007/s10165-010-0325-3. Epub 2010 Jun 24.
Our aim was to assess the ability of tocilizumab monotherapy to reduce progressive structural joint damage in rheumatoid arthritis patients at high risk of progression. This study was a subanalysis from a prospective 1-year, multicenter, X-ray-reader-blinded, randomized controlled trial of tocilizumab [Study of Active Controlled Monotherapy Used for Rheumatoid Arthritis, an IL-6 Inhibitor (SAMURAI) trial]. All patients were categorized into two or three groups according to four independent predictive markers for progressive joint damage [urinary C-terminal crosslinking telopeptide (uCTX-II), urinary pyridinoline/deoxypyridinoline (uPYD/DPD) ratio, body mass index (BMI), and joint-space narrowing (JSN) score at baseline]. One-year progression of joint destruction was assessed in high-risk versus low-risk groups receiving tocilizumab monotherapy and compared with patients receiving conventional disease-modifying antirheumatic drugs (DMARDs) (n = 157 and 145, respectively). In patients at high risk of progression of erosion as estimated by high uCTX-II, uPYD/DPD, or low BMI, and at high risk of progression of JSN as estimated by low BMI or high JSN score, the 52-week changes in radiological erosion and JSN, respectively, were significantly less in patients treated with tocilizumab monotherapy compared with those receiving DMARDs for each type of risk factor. In patients at low risk, those receiving tocilizumab also progressed less than those on DMARDs, although the difference did not reach statistical significance. Tocilizumab monotherapy is more effective in reducing radiological progression in patients presenting with risk factors for rapid progression than in low-risk patients. Patients at high risk for progression may benefit more from tocilizumab treatment.
我们的目的是评估托珠单抗单药治疗能否降低类风湿关节炎患者发生结构性关节损伤进展的风险。本研究是托珠单抗前瞻性 1 年、多中心、X 线阅片盲法、随机对照试验的亚分析(白细胞介素 6 抑制剂托珠单抗用于类风湿关节炎的主动对照单药治疗研究,即 SAMURAI 试验)。所有患者均根据 4 个独立的关节损伤进展预测标志物(尿 C 端交联肽/脱氧吡啶啉比,尿吡啶啉/脱氧吡啶啉比,体重指数和基线时关节间隙狭窄评分)分为 2 或 3 组。在高风险和低风险组中评估托珠单抗单药治疗和常规改善病情抗风湿药物(DMARDs)治疗的患者 1 年关节破坏进展情况(分别为 157 例和 145 例)。在估计存在高 uCTX-II、uPYD/DPD 或低 BMI 导致侵蚀进展风险高,或估计存在低 BMI 或高 JSN 评分导致 JSN 进展风险高的患者中,托珠单抗单药治疗患者的放射学侵蚀和 JSN 52 周变化分别显著低于 DMARDs 治疗的患者。在低风险患者中,托珠单抗治疗组的进展也低于 DMARDs 治疗组,但差异无统计学意义。托珠单抗单药治疗对存在快速进展风险因素的患者的放射学进展的疗效优于低风险患者。存在进展高风险的患者可能从托珠单抗治疗中获益更多。