Schoels M, Alasti F, Smolen J S, Aletaha D
Second Department of Internal Medicine, Hietzing Hospital, Vienna, Austria.
Division of Rheumatology, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Arthritis Res Ther. 2017 Jul 4;19(1):155. doi: 10.1186/s13075-017-1346-5.
Stringent remission criteria are crucial in rheumatoid arthritis (RA) assessment. Disease activity score in 28 joints (DAS28)-remission has not been included among American College of Rheumatology/European League Against Rheumatism definitions, because of its association with significant residual disease activity, partly due to high weighting of acute-phase reactants (APR). New, more stringent cut-points for DAS28-remission have recently been proposed that are suggested to reflect remission by clinical and simplified disease activity indices (clinical disease activity index (CDAI), simple disease activity index (SDAI)). However, their stringency in therapies directly influencing APR, like IL-6-blockers, has not been tested. We tested the new cut-points in patients with RA receiving tocilizumab.
We used data from randomised controlled trials of tocilizumab and evaluated patients in remission according to new DAS28-C-reactive protein (DAS-CRP) and DAS-erythrocyte sedimentation rate (DAS-ESR) cut-points (1.9 and 2.2). We assessed their disease activity state using the CDAI, SDAI and Boolean criteria and analysed their individual residual core set variables, like swollen joint counts (SJC28).
About 50% of patients in DAS28-CRP-remission (<1.9) fell into higher disease activity states when assessed with CDAI, SDAI or Boolean criteria. Also, 15% had three or more (up to eight) SJC. Even higher disease activity was seen in patients classified as being in DAS28-ESR-remission (<2.2).
Even with new, more stringent cut-points, DAS28-remission is frequently associated with considerable residual clinical disease activity, indicating that this limitation of the DAS28 is related to score construction rather than the choice of cut-points.
严格的缓解标准在类风湿关节炎(RA)评估中至关重要。28个关节疾病活动评分(DAS28)缓解未被纳入美国风湿病学会/欧洲抗风湿病联盟的定义中,因为它与显著的残余疾病活动相关,部分原因是急性期反应物(APR)权重较高。最近提出了更严格的DAS28缓解切点,建议通过临床和简化疾病活动指数(临床疾病活动指数(CDAI)、简化疾病活动指数(SDAI))来反映缓解情况。然而,它们在直接影响APR的疗法(如IL-6阻滞剂)中的严格性尚未得到检验。我们在接受托珠单抗治疗的RA患者中测试了新的切点。
我们使用了托珠单抗随机对照试验的数据,并根据新的DAS-28C反应蛋白(DAS-CRP)和DAS-红细胞沉降率(DAS-ESR)切点(1.9和2.2)评估缓解患者。我们使用CDAI、SDAI和布尔标准评估他们的疾病活动状态,并分析他们的个体残余核心集变量,如肿胀关节计数(SJC28)。
当用CDAI、SDAI或布尔标准评估时,DAS28-CRP缓解(<1.9)的患者中约50%处于更高的疾病活动状态。此外,15%的患者有三个或更多(最多八个)SJC。在被分类为DAS28-ESR缓解(<2.2)的患者中观察到更高的疾病活动。
即使采用新的、更严格的切点,DAS28缓解仍经常与相当程度的残余临床疾病活动相关,这表明DAS28的这一局限性与评分构建有关,而非切点的选择。