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A blood-based biomarker assay for multiple sclerosis (MS) disease activity provides actionable insights that supplement standard MS evaluations, especially for treatment initiation and de-escalation decisions, a real-world study showed.

A retrospective analysis of charts of more than 350 patients with MS revealed that integrating multi-analyte biomarker data from the Octave Bioscience’s Multiple Sclerosis Disease Activity (MSDA) Test changed clinical practice in nearly 20% of cases.

“One of the biggest challenges in MS management is determining when to adjust treatment,” lead investigator Taylor Gonyou, DO, a neurologist at the Michigan Institute for Neurological Disorders, said in a statement.

Including the test as part of a clinical workflow “enhances decision-making, particularly with repeated use, as confidence in the MSDA Test grows over time,” Gonyou added.

The study was published online recently in Multiple Sclerosis Journal – Experimental, Translational and Clinical.

Real-World Data

MSDA is a commercially available blood-based test that measures 18 proteins to derive a disease activity score. While previous studies had shown the test had high accuracy and specificity, investigators wanted to know how test use impacted clinical decision-making.

“Understanding the real-world clinical utility of a disease-specific, biology-based test like MSDA, in a complex disease such as MS, is a necessary step for ushering precision medicine into routine neurological practice,” the investigators wrote.

Gonyou and colleagues retrospectively examined 352 patient charts that were longitudinally evaluated by 20 clinicians across 14 sites that had utilized the MSDA as part of routine clinical care. Sites included academic medical centers, regional hospitals, and community neurology practices.

Chart reviews captured clinician decision-making before and after the receipt of each MSDA test result between 2022 and 2024, while separate clinician assessments also captured the perceived impact of MSDA on MS management. The analysis included a total of 723 MSDA test results. Most patients (90%) received two MSDA tests during the study period and 9.1% received three.

Clinical Utility

Clinician decisions changed in 19.4% of cases after receiving MSDA results — a rate notably higher than that reported in an MRI clinical utility study (4.4%) even in the presence of new, enlarged, or active lesions, the study team reported.

Test results were more likely to influence clinical decision-making when patients received multiple (longitudinal) MSDA tests compared with just one test (69.2% vs 59.8%).

However, the impact of MSDA test results on clinical decision-making was more pronounced following the first test than after the longitudinal tests. First MSDA tests led to a 23.4% change in management, while second and third tests led to changes in 16.1% and 10.3% of cases, respectively.

The majority of individual (single) time points examined had MSDA test scores in the low range — a pattern that indicates overall low disease activity in the chart population sampled, consistent with the observed high proportion of patients on high efficacy disease-modifying therapies (DMTs), the study team said.

They found three main patterns in how clinicians used MSDA Test results. A low test score supported a clinician’s plan to continue the patient’s current treatment plan or to change the treatment plan by discontinuing DMT. A high MSDA test score led the clinician to change the patient’s treatment plan by initiating or switching their DMT.

Nearly 60% of clinicians said they agreed or strongly agreed that a single MSDA test result helped with their decision-making. In cases where multiple MSDA test results were available over time, nearly 70% of clinicians agreed that the test was helpful in informing their decisions.

“The findings from this retrospective chart review study demonstrate the impact of MSDA on clinician decision-making in MS and provide evidence for the clinical utility of MSDA, particularly when used longitudinally approximately every 6 months to initiate, or switch DMT,” the investigators wrote.

Caveats and Cautionary Notes 

The authors noted several limitations to the study. Among them, participating sites were early adopters of the MSDA test in routine clinical practice and there was variability in how different sites and clinicians utilized the test results, which may limit generalizability.

Given the retrospective design of this study, the subjective interpretation of the impact of the MSDA on clinical decision-making may be impacted by recall bias. And due to the relatively short time frame, the long-term impact on patient outcomes was not captured.

Commenting on the findings for Medscape Medical News, Anthony T. Reder, MD, professor of neurology at the University of Chicago, Chicago, noted that the test is based on 18 biomarkers that correlate with MRI activity in MS.

“Several of the markers have strong correlations, others are logical but have low yield. Thus, it is a biomarker for MRI activity, perhaps relapses, and likely less so for progression, as the immune system is quite different in progressive MS vs relapsing-remitting MS [RRMS],” Reder explained.

“Enlightenment is good and this test adds immune markers to the clinical and MRI evaluations — important in an immune-mediated disease. These serum markers add to CSF immunoglobulin markers that also show inflammation and help with diagnosis of MS,” Reder added.

Reder also noted that the results changed practice in 20% of cases, but wondered, “Was the 20% change valid? That is, did it lead to better therapy or categorization? Would the test, correlated with RRMS events, miss progression or suggest changing treatment to therapies that only minimally affect progression?”

This study was supported by Octave Bioscience, Inc. Several authors disclosed relationships with the company. Reder had no relevant disclosures.