Clinical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis

Clin Immunol. 2023 Aug:253:109688. doi: 10.1016/j.clim.2023.109688. Epub 2023 Jul 4.

Abstract

An 18-protein multiple sclerosis (MS) disease activity (DA) test was validated based on associations between algorithm scores and clinical/radiographic assessments (N = 614 serum samples; Train [n = 426; algorithm development] and Test [n = 188; evaluation] subsets). The multi-protein model was trained based on presence/absence of gadolinium-positive (Gd+) lesions and was also strongly associated with new/enlarging T2 lesions, and active versus stable disease (composite of radiographic and clinical evidence of DA) with improved performance (p < 0.05) compared to the neurofilament light single protein model. The odds of having ≥1 Gd+ lesions with a moderate/high DA score were 4.49 times that of a low DA score, and the odds of having ≥2 Gd+ lesions with a high DA score were 20.99 times that of a low/moderate DA score. The MSDA Test was clinically validated with improved performance compared to the top-performing single-protein model and can serve as a quantitative tool to enhance the care of MS patients.

Keywords: Clinical validation; Gadolinium-positive lesion; MS disease activity; Multiple sclerosis.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Algorithms
  • Blood Proteins
  • Gadolinium
  • Humans
  • Magnetic Resonance Imaging
  • Multiple Sclerosis*

Substances

  • Blood Proteins
  • Gadolinium