Proft Fabian, Schally Julia, Brandt Henning Christian, Brandt-Juergens Jan, Rüdiger Burmester Gerd, Haibel Hildrun, Käding Henriette, Karberg Kirsten, Lüders Susanne, Muche Burkhard, Protopopov Mikhail, Rademacher Judith, Rios Rodriguez Valeria, Torgutalp Murat, Verba Maryna, Zinke Silke, Poddubnyy Denis
Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Hindenburgdamm 30, Berlin 12203, Germany.
Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Ther Adv Musculoskelet Dis. 2022 Mar 30;14:1759720X221085951. doi: 10.1177/1759720X221085951. eCollection 2022.
The objective of the study was to validate the Ankylosing Spondylitis Disease Activity Score (ASDAS) based on a quick quantitative C-reactive protein (qCRP) assay (ASDAS-Q) in a multicentre, prospective, cross-sectional study in patients with axial spondyloarthritis (axial SpA).
Disease activity assessment was performed in prospectively recruited patients with axial SpA. Routine laboratory CRP was determined in the central laboratory of each study centre, while quick qCRP and erythrocyte sedimentation rate (ESR) were measured locally. Consequently, ASDAS-CRP, ASDAS-Q using the qCRP and ASDAS-ESR were calculated. The absolute agreement on the disease activity category ascertainment was analysed with cross-tabulations and weighted Cohen's kappa. Bland-Altman plots and intraclass correlation coefficients (ICCs) were used to analyse the criterion validity.
Overall, 251 axial SpA patients were included in the analysis. The mean qCRP value (6.34 ± 11.13 mg/l) was higher than that of routine laboratory CRP (5.26 ± 9.35 mg/l). The ICC for routine laboratory CRP qCRP was 0.985 [95% confidence interval (CI): 0.972-0.991]. Comparing ASDAS-Q with ASDAS-CRP, 242 of 251 (96.4%) patients were assigned to the same disease activity categories with a weighted Cohen's kappa of 0.966 (95% CI: 0.943-0.988) and ICC of 0.997 (95% CI: 0.994-0.999).
ASDAS-Q showed an almost perfect agreement with ASDAS-CRP in the assignment to specific disease activity categories. Consequently, ASDAS-Q using the qCRP value can be applied as an accurate and quickly available alternative to ASDAS-CRP, thus facilitating the implementation of the treat-to-target concept in clinical trials and clinical routine.
本研究的目的是在一项针对中轴型脊柱关节炎（axial SpA）患者的多中心、前瞻性、横断面研究中，基于快速定量C反应蛋白（qCRP）检测方法验证强直性脊柱炎疾病活动评分（ASDAS）（ASDAS-Q）。
对前瞻性招募的中轴型SpA患者进行疾病活动评估。每个研究中心的中央实验室测定常规实验室CRP，同时在当地测量快速qCRP和红细胞沉降率（ESR）。因此，计算了ASDAS-CRP、使用qCRP的ASDAS-Q和ASDAS-ESR。通过交叉表和加权Cohen's kappa分析疾病活动类别确定的绝对一致性。使用Bland-Altman图和组内相关系数（ICC）分析标准效度。
总体而言，251例中轴型SpA患者纳入分析。qCRP的平均数值（6.34±11.13mg/l）高于常规实验室CRP（5.26±9.35mg/l）。常规实验室CRP与qCRP的ICC为0.985[95%置信区间（CI）：0.972-0.991]。将ASDAS-Q与ASDAS-CRP进行比较，251例患者中有242例（96.4%）被归为相同的疾病活动类别，加权Cohen's kappa为0.966（95%CI：0.943-0.988），ICC为0.997（95%CI：0.994-0.999）。
在特定疾病活动类别划分方面，ASDAS-Q与ASDAS-CRP显示出几乎完美的一致性。因此，使用qCRP值的ASDAS-Q可作为ASDAS-CRP的一种准确且快速可用的替代方法，从而有助于在临床试验和临床常规中实施达标治疗理念。
