在活动性中轴型脊柱关节炎患者中，探究性分析培塞丽珠单抗治疗后客观炎症反应与临床反应之间潜在的脱钩现象。
Exploratory analysis of the potential disconnect between objective inflammatory response and clinical response following certolizumab pegol treatment in patients with active axial spondyloarthritis.
机构信息
University of Bielefeld, Klinikum Bielefeld, Bielefeld, Germany
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
出版信息
RMD Open. 2024 Aug 28;10(3):e004369. doi: 10.1136/rmdopen-2024-004369.
INTRODUCTION
This post hoc analysis evaluated the relationship between objective measures of inflammation and clinical outcomes following 12 weeks of certolizumab pegol (CZP) treatment in patients with active axial spondyloarthritis (axSpA).
METHODS
We report the proportion of patients achieving ≥50% and ≥75% improvements in clinical composite outcome measures of disease activity (Axial Spondyloarthritis Disease Activity Score [ASDAS], Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]) and objective measures of inflammation (C reactive protein [CRP], Ankylosing Spondylitis spine MRI score [ASspiMRI-a] Berlin score and Spondyloarthritis Research Consortium of Canada [SPARCC] MRI Sacroiliac Joints [SIJ] score) following 12 weeks of CZP treatment. Data from two independent readers over four MRI reading campaigns were pooled using a mixed model with repeated measures for each variable.
RESULTS
136 patients (radiographic axSpA [r-axSpA]: 76; non-radiographic axSpA [nr-axSpA]: 60) were included. Following CZP treatment, CRP, ASspiMRI-a Berlin score and SPARCC SIJ score were reduced by ≥50% in most patients (CRP: 136/136 [100.0%]; Berlin: 73/136 [53.7%]; SPARCC SIJ: 71/136 [52.2%]), and often by ≥75%. Less than half of patients with r-axSpA and nr-axSpA showed ≥50% reduction in clinical responses (BASDAI: 64/136 [47.1%]; ASDAS: 66/136 [48.5%]). These results were also observed at the individual patient level; ≥50% improvements in MRI/CRP inflammatory measures did not translate into similar improvements in clinical responses for most patients.
CONCLUSION
There is a potential disconnect between objective measures of inflammation and clinical outcome responses in patients with axSpA. The use of only clinical response measures as trial endpoints may underestimate anti-inflammatory treatment effects.
TRIAL REGISTRATION NUMBER
NCT01087762.
介绍
本事后分析评估了在活动性中轴型脊柱关节炎（axSpA）患者接受 12 周培塞利珠单抗（CZP）治疗后，客观炎症指标与临床结局之间的关系。
方法
我们报告了在接受 12 周 CZP 治疗后，疾病活动的临床综合结局指标（Axial Spondyloarthritis Disease Activity Score [ASDAS]、Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]）和客观炎症指标（C 反应蛋白 [CRP]、Ankylosing Spondylitis spine MRI score [ASspiMRI-a]Berlin 评分和 Spondyloarthritis Research Consortium of Canada [SPARCC] MRI Sacroiliac Joints [SIJ] 评分）改善≥50%和≥75%的患者比例。使用混合模型，对每个变量进行重复测量，汇总了两个独立阅读活动中的 136 名患者（影像学中轴型 SpA [r-axSpA]：76 名；非影像学中轴型 SpA [nr-axSpA]：60 名）的数据。
结果
在接受 CZP 治疗后，大多数患者的 CRP、ASspiMRI-a Berlin 评分和 SPARCC SIJ 评分降低了≥50%（CRP：136/136 [100.0%]；Berlin：73/136 [53.7%]；SPARCC SIJ：71/136 [52.2%]），且经常降低≥75%。只有不到一半的 r-axSpA 和 nr-axSpA 患者的临床反应显示≥50%的降低（BASDAI：64/136 [47.1%]；ASDAS：66/136 [48.5%]）。这些结果在个体患者水平上也观察到；对于大多数患者来说，MRI/CRP 炎症指标的≥50%改善并没有转化为类似的临床反应改善。
结论
在 axSpA 患者中，客观炎症指标与临床结局反应之间可能存在脱节。仅将临床反应指标作为试验终点可能会低估抗炎治疗效果。
试验注册号
NCT01087762。
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