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

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.