Testing different thresholds for patient global assessment in defining remission for rheumatoid arthritis: are the current ACR/EULAR Boolean criteria optimal?
Testing different thresholds for patient global assessment in defining remission for rheumatoid arthritis: are the current ACR/EULAR Boolean criteria optimal?
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DOI：
10.1136/annrheumdis-2019-216529
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发表时间：
2020-04
影响因子：
27.4
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中科院分区：
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本研究旨在评价美国风湿病学会/欧洲抗风湿联盟（ACR/EULAR）布尔缓解定义中要求的不同患者总体评估（PGA）临界值在类风湿性关节炎（RA）中的效用。我们使用了6项早期和确诊RA的随机对照试验的数据。我们将PGA的0-10分阈值以0.5（布尔1.5至布尔3.0）的步长从1逐渐增加到3，并在6个月和12个月时完全忽略PGA（布尔X）。使用kappa、递归划分（分类和回归树（CART））和受试者操作特征分析与基于指数（简化疾病活动指数（SDAI））的缓解定义的一致性。探讨了1年后达到每种定义对功能和影像学结局的影响。纳入了1680例早期RA患者和920例确诊RA患者的数据。达到布尔缓解的患者比例随着PGA阈值的升高而增加，早期为12.4%至19.7%，6个月时确诊RA为5.9%至12.3%。与SDAI缓解的最佳一致性发生在PGA临界值1.5和2.0时，而一致性随着PGA的升高而降低（CART：PGA≤1.6 cm时的最佳一致性; PGA的灵敏度≤1.5 95%）。6个月时改变PGA阈值不影响12个月时的影像学进展（布尔型、1.5、2.0、2.5、3.0，布尔型X的平均TSS：0.35±5.4、0.38±5.14、0.41±5.1、0.37±4.9、0.34±4.9、0.27±4.7）。然而，对于相应的布尔定义，达到HAQ≤0.5的比例分别为90.2%、87.9%、85.2%、81.1%、80.7%和73.1%。将PGA截止值增加到1.5 cm将提供布尔值与基于指数的缓解之间的高度一致性; 2.0 cm的整数截止值表现相似。
This study aimed to evaluate different patient global assessment (PGA) cut-offs required in the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean remission definition for their utility in rheumatoid arthritis (RA). We used data from six randomised controlled trials in early and established RA. We increased the threshold for the 0–10 score for PGA gradually from 1 to 3 in steps of 0.5 (Boolean1.5 to Boolean3.0) and omitted PGA completely (BooleanX) at 6 and 12 months. Agreement with the index-based (Simplified Disease Activity Index (SDAI)) remission definition was analysed using kappa, recursive partitioning (classification and regression tree (CART)) and receiver operating characteristics. The impact of achieving each definition on functional and radiographic outcomes after 1 year was explored. Data from 1680 patients with early RA and 920 patients with established RA were included. The proportion of patients achieving Boolean remission increased with higher thresholds for PGA from 12.4% to 19.7% in early and 5.9% to 12.3% in established RA at 6 months. Best agreement with SDAI remission occurred at PGA cut-offs of 1.5 and 2.0, while agreement decreased with higher PGA (CART: optimal agreement at PGA≤1.6 cm; sensitivity of PGA≤1.5 95%). Changing PGA thresholds at 6 months did not affect radiographic progression at 12 months (mean ∆smTSS for Boolean, 1.5, 2.0, 2.5, 3.0, BooleanX: 0.35±5.4, 0.38±5.14, 0.41±5.1, 0.37±4.9, 0.34±4.9, 0.27±4.7). However, the proportion attaining HAQ≤0.5 was 90.2%, 87.9%, 85.2%, 81.1%, 80.7% and 73.1% for the respective Boolean definitions. Increasing the PGA cut-off to 1.5 cm would provide high consistency between Boolean with the index-based remission; the integer cut-off of 2.0 cm performed similarly.
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