Department of Clinical Research, Matsubara Mayflower Hospital, 944-25 Fujita, Kato, Hyogo, 673-1462, Japan.
Mod Rheumatol. 2009;19(5):507-12. doi: 10.1007/s10165-009-0203-z. Epub 2009 Jul 17.
Tocilizumab, a biological agent developed in Japan, is a human anti-interleukin-6 (anti-IL-6) receptor antibody. Rheumatoid arthritis improves with its use. A remission rate of 59% is attainable, as measured by disease activity score 28 (DAS28) in the SAMURAI study. However, in tocilizumab treatment, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) levels drop to negative values; therefore we sought to utilize a different index for measuring its efficacy. In order to evaluate the effects of tocilizumab we carried out this study using clinical disease activity index (CDAI), as it is not reliant on blood data and would also allow us to determine which markers are present in remission. Twenty-two patients under treatment with tocilizumab participated in this study. Effects of treatment as well as the remission rate were measured by CDAI and DAS28 3 months after initiation of treatment. IL-6 and matrix metalloproteinase-3 (MMP-3) levels were measured at the same time. We studied the clinical efficacy of tocilizumab using DAS28 after treatment; remission as measured by DAS28 was 57.1% at 1 year. However, the remission rate as measured by CDAI was only 19.1% at 1 year. CDAI was not only correlated with DAS28, but also other clinical variables, MMP-3, and IL-6. We conclude that CDAI is effective in measuring clinical response to tocilizumab treatment, and that MMP-3 level is as useful as IL-6 level as an indicator.
托珠单抗是一种在日本开发的生物制剂，是一种人抗白细胞介素-6（抗-IL-6）受体抗体。其使用可改善类风湿关节炎。SAMURAI 研究表明，使用托珠单抗的缓解率可达 59%，用疾病活动评分 28（DAS28）测量。然而，在托珠单抗治疗中，C 反应蛋白（CRP）和红细胞沉降率（ESR）水平降至负值；因此，我们试图使用不同的指标来衡量其疗效。为了评估托珠单抗的疗效，我们进行了这项研究，使用临床疾病活动指数（CDAI），因为它不依赖于血液数据，也可以确定哪些标志物处于缓解状态。22 名正在接受托珠单抗治疗的患者参与了这项研究。在开始治疗后 3 个月，通过 CDAI 和 DAS28 测量治疗效果和缓解率。同时测量 IL-6 和基质金属蛋白酶-3（MMP-3）水平。我们使用 DAS28 研究治疗后托珠单抗的临床疗效；1 年后 DAS28 测量的缓解率为 57.1%。然而，1 年后 CDAI 测量的缓解率仅为 19.1%。CDAI 不仅与 DAS28 相关，还与其他临床变量、MMP-3 和 IL-6 相关。我们得出结论，CDAI 可有效测量托珠单抗治疗的临床反应，MMP-3 水平与 IL-6 水平一样可作为指标。
