探索性分析活动性轴性脊柱关节炎患者接受赛妥珠单抗 pegol 治疗后客观炎症反应与临床反应之间可能存在的脱节。

IF 5.1 2区医学 Q1 RHEUMATOLOGY RMD Open Pub Date : 2024-08-28 DOI:10.1136/rmdopen-2024-004369

Martin Rudwaleit, Helena Marzo-Ortega, Victoria Navarro-Compán, Rachel Tham, Thomas Kumke, Lars Bauer, Natasha de Peyrecave, Mindy Kim, Filip Van den Bosch

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引用次数: 0

摘要

简介这项事后分析评估了活动性轴性脊柱关节炎（axSpA）患者接受12周certolizumab pegol（CZP）治疗后炎症的客观指标与临床结果之间的关系：我们报告了在疾病活动性（轴性脊柱关节炎疾病活动性评分[ASDAS]、巴斯强直性脊柱炎疾病活动性指数[BASDAI]）和炎症客观指标（C反应蛋白[CRP]）的临床综合结果测量中改善≥50%和≥75%的患者比例、CZP治疗12周后的强直性脊柱炎脊柱MRI评分[ASspiMRI-a]柏林评分和加拿大脊柱关节炎研究协会[SPARCC]MRI骶髂关节[SIJ]评分）。采用混合模型对每个变量进行重复测量，将两个独立读片者在四次磁共振成像读片活动中获得的数据进行汇总：结果：共纳入136名患者（放射学axSpA [r-axSpA]：76人；非放射学axSpA [nr-axSpA]：60人）。接受CZP治疗后，大多数患者的CRP、ASspiMRI-a柏林评分和SPARCC SIJ评分降低了≥50%（CRP：136/136 [100.0%]；柏林：73/136 [53.7%]；SPARCC SIJ：71/136 [52.2%]），通常降低了≥75%。不到一半的 r-axSpA 和 nr-axSpA 患者的临床反应减少了≥50%（BASDAI：64/136 [47.1%]；ASDAS：66/136 [48.5%]）。在单个患者层面也观察到了这些结果；MRI/CRP炎症指标≥50%的改善并没有转化为大多数患者临床反应的类似改善：结论：axSpA 患者的客观炎症指标与临床结果反应之间可能存在脱节。试验注册号：NCT01087762：NCT01087762.

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Exploratory analysis of the potential disconnect between objective inflammatory response and clinical response following certolizumab pegol treatment in patients with active axial spondyloarthritis.

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.

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来源期刊

RMD Open RHEUMATOLOGY-

CiteScore

7.30

自引率

6.50%

发文量

205

审稿时长

14 weeks

期刊介绍： RMD Open publishes high quality peer-reviewed original research covering the full spectrum of musculoskeletal disorders, rheumatism and connective tissue diseases, including osteoporosis, spine and rehabilitation. Clinical and epidemiological research, basic and translational medicine, interesting clinical cases, and smaller studies that add to the literature are all considered.