New York University School of Medicine and New York University Hospital for Joint Diseases, 301 East 17th Street, New York, NY 10003, USA.
Arthritis Care Res (Hoboken). 2011 Aug;63(8):1142-9. doi: 10.1002/acr.20481.
To compare categories for activity/severity according to the Disease Activity Score 28-joint count (DAS28), the Clinical Disease Activity Index (CDAI), and the Routine Assessment of Patient Index Data 3 (RAPID3), an index without formal joint counts calculated in 5 versus >100 seconds, as well as the European League Against Rheumatism (EULAR)- DAS28 and the RAPID3 response criteria, in the Rheumatoid Arthritis Prevention of Structural Damage (RAPID 1) clinical trial of certolizumab pegol (CZP).
Post hoc analyses were performed using correlations, cross-tabulations, and kappa statistics. Patients (treated with CZP plus methotrexate [MTX] or placebo plus MTX) were classified at baseline and at 52 weeks as high, moderate, low activity/severity or remission, according to the DAS28 (>5.1, >3.2 to ≤5.1, 2.6 to ≤3.2, <2.6 [total range 0-10]), the CDAI (>22, >10 to ≤22, >2.8 to ≤10, ≤2.8 [total range 0-76]), and RAPID3 (>12, >6 to ≤12, >3 to ≤6, ≤3 [total range 0-30]), as well as for good, moderate, and poor EULAR-DAS28 and proposed RAPID3 response criteria.
All measures were correlated significantly: RAPID3 with DAS28 and CDAI (rho > 0.7), higher than erythrocyte sedimentation rate with C-reactive protein level (rho = 0.47). At 52 weeks, DAS28, CDAI, and RAPID3 low activity/remission was seen in 30%, 44%, and 42% of CZP-treated patients versus 3%, 7%, and 10% of control patients. Good, moderate, and poor EULAR-DAS28 responses were seen in 30%, 51%, and 19% of CZP-treated patients versus 3%, 28%, and 70% of control patients, and for RAPID3 in 39%, 30%, and 32% of CZP-treated patients versus 8%, 16%, and 76% of control patients. Kappa and weighted kappa values ranged from 0.36-0.53, indicating fair to moderate agreement.
RAPID3, DAS28, and CDAI give similar results to distinguish CZP patients from controls in the RAPID 1 clinical trial. DAS28 is specific for clinical trials; RAPID3 appears pragmatically useful for usual care.
比较疾病活动评分 28 关节计数（DAS28）、临床疾病活动指数（CDAI）和常规评估患者指数数据 3（RAPID3）的活动/严重程度分类，RAPID3 是一个不包含正式关节计数的指数，计算时间为 5 秒或>100 秒，以及欧洲抗风湿病联盟（EULAR）-DAS28 和 RAPID3 反应标准，在 certolizumab pegol（CZP）的类风湿关节炎预防结构损伤（RAPID 1）临床试验中。
采用相关性、交叉表和kappa 统计进行事后分析。根据 DAS28（>5.1、>3.2 至≤5.1、2.6 至≤3.2、<2.6[总范围 0-10]）、CDAI（>22、>10 至≤22、>2.8 至≤10、≤2.8[总范围 0-76]）和 RAPID3（>12、>6 至≤12、>3 至≤6、≤3[总范围 0-30]），将接受 CZP 加甲氨蝶呤（MTX）或安慰剂加 MTX 治疗的患者（基线和 52 周）分为高、中、低活动/严重程度或缓解，以及良好、中度和不良 EULAR-DAS28 和拟议的 RAPID3 反应标准。
所有指标均呈显著相关性：RAPID3 与 DAS28 和 CDAI（rho>0.7），高于红细胞沉降率与 C 反应蛋白水平（rho=0.47）。在 52 周时，30%、44%和 42%的 CZP 治疗患者达到 DAS28、CDAI 和 RAPID3 低活动/缓解，而对照组患者为 3%、7%和 10%。30%、51%和 19%的 CZP 治疗患者达到良好、中度和不良 EULAR-DAS28 反应，而对照组患者为 3%、28%和 70%，RAPID3 治疗患者为 39%、30%和 32%，对照组患者为 8%、16%和 76%。kappa 和加权 kappa 值范围为 0.36-0.53，表明一致性为中等至良好。
RAPID3、DAS28 和 CDAI 可提供类似的结果，以区分 RAPID 1 临床试验中 CZP 患者与对照组患者。DAS28 适用于临床试验；RAPID3 似乎在常规护理中具有实际用途。
