Division of Rheumatology, Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden
Division of Rheumatology, Department of Internal Medicine 3, Medical University of Vienna, Vienna, Austria.
Ann Rheum Dis. 2023 Jan;82(1):74-80. doi: 10.1136/ard-2022-223413. Epub 2022 Oct 24.
In 2011, the American College of Rheumatology (ACR) and EULAR endorsed provisional criteria for remission in rheumatoid arthritis (RA), both Boolean-based and index-based. Based on recent studies indicating that a higher threshold for the patient global assessment (PtGA) may improve agreement between the two sets of criteria, our goals were to externally validate a revision of the Boolean remission criteria using a higher PtGA threshold and to validate the provisionally endorsed index-based criteria.
We used data from four randomised trials comparing biological disease-modifying antirheumatic drugs to methotrexate or placebo. We tested the higher proposed PtGA threshold of 2 cm (Boolean2.0) (range 0-10 cm) compared with the original threshold of 1 cm (Boolean1.0). We analysed agreement between the Boolean-based and index-based criteria (Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI)) for remission and examined how well each remission definition predicted later good physical function (Health Assessment Questionnaire (HAQ) score≤0.5) and radiographic non-progression.
Data from 2048 trial participants, 1101 with early RA and 947 with established RA, were included. The proportion of patients with disease in remission at 6 months after treatment initiation increased when using Boolean2.0 compared with Boolean1.0, from 14.8% to 20.6% in early RA and 4.2% to 6.0% in established RA. Agreement between Boolean2.0 and the SDAI or CDAI remission criteria was better than for Boolean1.0, particularly in early disease. Boolean2.0, SDAI, and CDAI remission criteria had similar positive likelihood ratios (LRs) to predict radiographic nonprogression and a HAQ score of ≤0.5 (positive LR 3.8-4.3). The omission of PtGA (BooleanX) worsened the prediction of good functional outcomes.
Using the Boolean 2.0 criteria classifies, more patients as achieving remission and increases the agreement with index-based remission criteria without jeopardising predictive value for radiographic or functional outcomes. This revised Boolean definition and the previously provisionally endorsed index-based criteria were endorsed by ACR and EULAR.
2011 年,美国风湿病学会(ACR)和欧洲抗风湿病联盟(EULAR)认可了类风湿关节炎(RA)缓解的暂定标准,包括基于布尔逻辑和指数的标准。基于最近的研究表明,提高患者整体评估(PtGA)的阈值可能会提高这两套标准之间的一致性,我们的目标是使用更高的 PtGA 阈值来验证布尔缓解标准的修订版本,并验证临时认可的基于指数的标准。
我们使用了四项比较生物疾病修饰抗风湿药物与甲氨蝶呤或安慰剂的随机试验数据。我们测试了更高的提议的 PtGA 阈值 2cm(Boolean2.0)(范围 0-10cm)与原始阈值 1cm(Boolean1.0)相比。我们分析了基于布尔的和基于指数的标准(简化疾病活动指数(SDAI)和临床疾病活动指数(CDAI))之间的缓解一致性,并检查了每种缓解定义如何更好地预测后来的良好身体功能(健康评估问卷(HAQ)评分≤0.5)和放射学进展。
纳入了 2048 名试验参与者的数据,其中 1101 名患有早期 RA,947 名患有确诊 RA。与 Boolean1.0 相比,在治疗开始后 6 个月时,使用 Boolean2.0 的患者疾病缓解比例增加,从早期 RA 的 14.8%增加到 20.6%,从确诊 RA 的 4.2%增加到 6.0%。与布尔 2.0 相比,布尔 2.0 与 SDAI 或 CDAI 缓解标准之间的一致性更好,尤其是在早期疾病中。Boolean2.0、SDAI 和 CDAI 缓解标准对预测放射学进展和 HAQ 评分≤0.5(阳性似然比 3.8-4.3)具有相似的阳性预测值。省略 PtGA(BooleanX)会降低良好功能结果的预测准确性。
使用布尔 2.0 标准可以将更多的患者分类为缓解,并增加与基于指数的缓解标准的一致性,而不会影响放射学或功能结果的预测值。这个修订的布尔定义和之前临时认可的基于指数的标准得到了 ACR 和 EULAR 的认可。