Department of Rheumatology, Centre Hospitalier Universitaire de Brest, Brest, France
Public Agency for Clinical Research and Innovation (DRCI), Brest University Hospital, Centre Hospitalier Universitaire de Brest, Brest, France.
RMD Open. 2024 Mar 15;10(1):e003741. doi: 10.1136/rmdopen-2023-003741.
The C reactive protein polymyalgia rheumatica activity score (CRP-PMR-AS) is a composite index that includes CRP levels and was developed specifically for PMR. As treatments such as interleukin-6 antagonists can normalise CRP levels, the erythrocyte sedimentation rate (ESR) of PMR-AS, the clinical (clin)-PMR-AS and the imputed-CRP (imp-CRP)-PMR-AS have been developed to avoid such bias. Our primary objective was to measure the correlation of these activity scores. Our secondary objective was to evaluate the concordance between different cutoffs of the PMR-ASs.
Data from the Safety and Efficacy of tocilizumab versus Placebo in Polymyalgia rHeumatica With glucocORticoid dEpendence (SEMAPHORE) trial, a superiority randomised double-blind placebo-controlled trial, were subjected to post hoc analysis to compare the efficacy of tocilizumab versus placebo in patients with active PMR. The CRP-PMR-AS, ESR-PMR-AS, clin-PMR-AS and imp-CRP-PMR-AS were measured at every visit. The concordance and correlation between these scores were evaluated using kappa correlation coefficients, Bland-Altman correlations, intraclass correlation coefficients (ICCs) and scatter plots.
A total of 101 patients were included in the SEMAPHORE trial, and 100 were analysed in this study. The correlation between the PMR-ASs was excellent, as the ICC and kappa were >0.85 from week 4 until week 24 (CRP-PMR-AS ≤10 or >10). Bland-Altman plots revealed that the differences between the CRP-PMR-AS and the other threescores were low. The cut-off values for the clin-PMR-AS were similar to those for the CRP-PMR-AS 86% of the time.
The correlation between all the PMR-ASs was excellent, reflecting the low weight of CRP. In clinical trials using drugs that have an impact on CRP, the derived activity scores can be used.
NTC02908217.
C 反应蛋白巨细胞动脉炎活动评分(CRP-PMR-AS)是一个包含 CRP 水平的综合指标,专门为 PMR 开发。由于白细胞介素-6 拮抗剂等治疗方法可以使 CRP 水平正常化,因此开发了红细胞沉降率(ESR)PMR-AS、临床(clin)-PMR-AS 和推断 CRP(imp-CRP)-PMR-AS,以避免这种偏差。我们的主要目标是测量这些活动评分之间的相关性。我们的次要目标是评估不同 PMR-AS 截止值之间的一致性。
对来自托珠单抗与安慰剂治疗巨细胞动脉炎伴糖皮质激素依赖性(SEMAPHORE)试验的安全性和疗效的事后分析数据进行分析,这是一项优效性随机双盲安慰剂对照试验,以比较托珠单抗与安慰剂在活动性 PMR 患者中的疗效。在每次就诊时测量 CRP-PMR-AS、ESR-PMR-AS、clin-PMR-AS 和 imp-CRP-PMR-AS。使用kappa 相关系数、Bland-Altman 相关性、组内相关系数(ICC)和散点图评估这些评分之间的一致性和相关性。
SEMAPHORE 试验共纳入 101 例患者,本研究分析了 100 例患者。从第 4 周直到第 24 周,PMR-AS 之间的相关性非常好,ICC 和 kappa 均>0.85(CRP-PMR-AS≤10 或>10)。Bland-Altman 图显示 CRP-PMR-AS 与其他三种评分之间的差异较小。clin-PMR-AS 的截止值与 CRP-PMR-AS 的截止值相似,约 86%的时间都如此。
所有 PMR-AS 之间的相关性都非常好,反映了 CRP 的权重较低。在使用对 CRP 有影响的药物进行临床试验时,可以使用这些衍生的活动评分。
NTC02908217。