Real-world clinical utility of a multi-protein, blood-based biomarker assay for disease activity assessments in multiple sclerosis.

IF 2.5 Q2 CLINICAL NEUROLOGY

Multiple Sclerosis Journal - Experimental, Translational and Clinical Pub Date : 2025-04-16 eCollection Date: 2025-04-01 DOI:10.1177/20552173251331030

Angela Sanchez, Elisa Sheng, Sarah Eagleman, James L Eubanks, Patricia Izbicki, Shannon McCurdy, Matt Burril, Ferhan Qureshi, Ati Ghoreyshi, Mitzi Joi Williams, Megan Weigel, William Kilgo, Jacqueline Nicholas, Annette Okai, Martin Belkin, Julie Burnham, Yasir Jassam, Michael Sy, Taylor Gonyou

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Abstract

Background: Blood-based biomarkers have emerged as promising tools to optimize treatment decisions in multiple sclerosis (MS) including initiation, switch, or cessation of disease modifying therapies.

Objectives: The clinically validated MS disease activity (MSDA) test measures 18 proteins to derive a disease activity score. This study tests the clinical utility of MSDA in real-world practice.

Methods: Twenty clinicians from 14 clinics conducted a chart review utilizing a retrospective, longitudinal design, with a pre-post component. Chart reviews captured clinician decision-making before and after receipt of each MSDA result, while separate clinician assessments also captured the perceived impact of MSDA on MS management.

Results: A total of 352 charts were reviewed. The overall rate of clinical decision changes after MSDA testing (19.4%) exceeded predefined benchmarks. The proportion of patient time points where clinicians "strongly agreed" or "agreed" that MSDA results influenced their decision-making was greater when multiple longitudinal MSDA results were available compared to a single result: 69.2% (95%CI: [60.2%, 78.3%) vs. 59.8% (95%CI: [43.7%, 76.0%]), respectively.

Conclusion: When used in addition to standard of care, MSDA demonstrates clinical utility for real-world decision-making in MS management, based on objective changes in treatment plan and clinician-reported impact, which increases with longitudinal use.

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多发性硬化症疾病活动性评估中基于血液的多蛋白生物标志物测定的临床应用

背景：基于血液的生物标志物已成为优化多发性硬化症（MS）治疗决策的有希望的工具，包括开始、切换或停止疾病修饰治疗。目的：临床验证的MS疾病活动性（MSDA）测试测量18种蛋白质来得出疾病活动性评分。本研究在实际实践中检验MSDA的临床应用。方法：来自14家诊所的20名临床医生采用回顾性、纵向设计、前后成分进行了图表回顾。图表回顾记录了临床医生在收到每个MSDA结果之前和之后的决策，而单独的临床医生评估也记录了MSDA对MS管理的感知影响。结果：共审查352张图表。MSDA检测后临床决策改变的总体比率（19.4%）超过了预先设定的基准。与单一结果相比，当多个纵向MSDA结果可用时，临床医生“强烈同意”或“同意”MSDA结果影响其决策的患者时间点比例更大：分别为69.2% （95%CI:[60.2%, 78.3%）和59.8% （95%CI:[43.7%, 76.0%]）。结论：在标准治疗之外使用MSDA，基于治疗计划的客观变化和临床报告的影响，MSDA在MS管理的现实决策中显示出临床效用，这种效用随着纵向使用而增加。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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