Multiple sclerosis (Houndmills, Basingstoke, England) · 2026
Longitudinal short-term assessments of single- and multi-protein disease activity biomarkers to determine reliability and the minimum detectable change in people with clinically stable RRMS.
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McCurdy Shannon, Sheng Elisa, Jalaleddini Kian, Datta Gargi, Shabi Tamara, Miner Annalise E, Hari Alexander, Tiwari Srushti, Hu Wayne, Faust Franklin, Leyden Kelly, Eagleman Sarah, Brazel David M, Livingston Terrie, Qureshi Ferhan, Graves Jennifer S
Аннотация
OBJECTIVES: This study aims to evaluate the ability of a multi-protein biomarker score to characterize clinical stability in relapsing-remitting multiple sclerosis (RRMS) compared to that of single-protein markers.
METHODS: Serum was collected from 62 out of 86 MOVING MS participants over 12 months (Nsamples = 186). Multiple Sclerosis Disease Activity (DA) scores were calculated from 18 proteins, sex, and age. In a clinically stable subcohort, the DA score reliability was compared to single biomarkers, and the minimum detectable change at 95% confidence (MDC95) was estimated. An independent cohort (N = 128) was used to assess whether change in the DA score > MDC95 was associated with odds of gadolinium-enhancing (Gd+) lesions.
RESULTS: In 34 clinically stable MOVING MS participants, the DA score demonstrated directionally stronger test-retest reliability (rXX' = 0.92, 95% CI = [0.79, 0.97]) than NfL (rXX' = 0.75, 95% CI = [0.47, 0.91]) and GFAP (rXX' = 0.71, 95% CI = [0.46, 0.89]). The DA score MDC95 was 1.24 units (95% CI = [0.74, 1.73]). In the independent cohort, DA score increases that were greater/less than the MDC95 were significantly associated with increased/decreased odds of Gd+ lesions across the DA score range.
CONCLUSIONS: The DA score directionally outperformed NfL and GFAP in test-retest reliability. The MDC95 of 1.24 units provides a threshold for interpreting DA score changes, supporting its use for monitoring disease activity in RRMS.
METHODS: Serum was collected from 62 out of 86 MOVING MS participants over 12 months (Nsamples = 186). Multiple Sclerosis Disease Activity (DA) scores were calculated from 18 proteins, sex, and age. In a clinically stable subcohort, the DA score reliability was compared to single biomarkers, and the minimum detectable change at 95% confidence (MDC95) was estimated. An independent cohort (N = 128) was used to assess whether change in the DA score > MDC95 was associated with odds of gadolinium-enhancing (Gd+) lesions.
RESULTS: In 34 clinically stable MOVING MS participants, the DA score demonstrated directionally stronger test-retest reliability (rXX' = 0.92, 95% CI = [0.79, 0.97]) than NfL (rXX' = 0.75, 95% CI = [0.47, 0.91]) and GFAP (rXX' = 0.71, 95% CI = [0.46, 0.89]). The DA score MDC95 was 1.24 units (95% CI = [0.74, 1.73]). In the independent cohort, DA score increases that were greater/less than the MDC95 were significantly associated with increased/decreased odds of Gd+ lesions across the DA score range.
CONCLUSIONS: The DA score directionally outperformed NfL and GFAP in test-retest reliability. The MDC95 of 1.24 units provides a threshold for interpreting DA score changes, supporting its use for monitoring disease activity in RRMS.