一种用于多发性硬化症疾病活动评估的基于血液的多蛋白生物标志物检测方法在现实世界中的临床应用。

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

作者信息

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

机构信息

Octave Bioscience Inc., Menlo Park, CA, USA.

Joi Life Wellness, Smyrna, GA, USA.

出版信息

Mult Scler J Exp Transl Clin. 2025 Apr 16;11(2):20552173251331030. doi: 10.1177/20552173251331030. eCollection 2025 Apr-Jun.

DOI:10.1177/20552173251331030

PMID:40292039

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12033869/

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 clinicianreported impact, which increases with longitudinal use.

摘要

背景

基于血液的生物标志物已成为优化多发性硬化症（MS）治疗决策的有前景的工具，包括启动、转换或停止疾病修正疗法。

目的

经过临床验证的MS疾病活动度（MSDA）测试可测量18种蛋白质以得出疾病活动度评分。本研究测试了MSDA在实际临床中的应用价值。

方法

来自14家诊所的20名临床医生采用回顾性纵向设计并包含前后对照成分进行了病历审查。病历审查记录了临床医生在收到每个MSDA结果之前和之后的决策过程，同时独立的临床医生评估也记录了MSDA对MS管理的感知影响。

结果

共审查了352份病历。MSDA测试后临床决策改变的总体发生率（19.4%）超过了预先设定的基准。与单个结果相比，当有多个纵向MSDA结果时，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高：分别为69.2%（95%CI：[60.2%，78.3%]）和59.8%（95%CI：[43.7%，76.0%]）。