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

Tanuja Chitnis; John Foley; Carolina Ionete; Nabil K. El Ayoubi; Shrishti Saxena; Patricia Gaitan-Walsh; Hrishikesh Lokhande; Anu Paul; Fermisk Saleh; Howard Weiner; Ferhan Qureshi; Michael J. Becich; Fatima Rubio da Costa; Victor M. Gehman; Fujun Zhang; Anisha Keshavan; Kian Jalaleddini; Ati Ghoreyshi; Samia J. Khoury

doi:10.1016/j.clim.2023.109688

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

Tanuja Chitnis, John Foley, Carolina Ionete, Nabil K. El Ayoubi, Shrishti Saxena, Patricia Gaitan-Walsh, Hrishikesh Lokhande, Anu Paul, Fermisk Saleh, Howard Weiner, Ferhan Qureshi^*, Michael J. Becich, Fatima Rubio da Costa, Victor M. Gehman, Fujun Zhang, Anisha Keshavan, Kian Jalaleddini, Ati Ghoreyshi, Samia J. Khoury

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Article number	109688
Journal	Clinical Immunology
Volume	253
DOIs	https://doi.org/10.1016/j.clim.2023.109688
State	Published - Aug 2023
Externally published	Yes

Keywords

Clinical validation
Gadolinium-positive lesion
MS disease activity
Multiple sclerosis

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10.1016/j.clim.2023.109688

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Chitnis, T., Foley, J., Ionete, C., El Ayoubi, N. K., Saxena, S., Gaitan-Walsh, P., Lokhande, H., Paul, A., Saleh, F., Weiner, H., Qureshi, F., Becich, M. J., da Costa, F. R., Gehman, V. M., Zhang, F., Keshavan, A., Jalaleddini, K., Ghoreyshi, A., & Khoury, S. J. (2023). Clinical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis. Clinical Immunology, 253, Article 109688. https://doi.org/10.1016/j.clim.2023.109688

@article{9ab1684663b54368b3ed1b1026912331,

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

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",

author = "Tanuja Chitnis and John Foley and Carolina Ionete and {El Ayoubi}, {Nabil K.} and Shrishti Saxena and Patricia Gaitan-Walsh and Hrishikesh Lokhande and Anu Paul and Fermisk Saleh and Howard Weiner and Ferhan Qureshi and Becich, {Michael J.} and {da Costa}, {Fatima Rubio} and Gehman, {Victor M.} and Fujun Zhang and Anisha Keshavan and Kian Jalaleddini and Ati Ghoreyshi and Khoury, {Samia J.}",

note = "Publisher Copyright: {\textcopyright} 2023",

year = "2023",

month = aug,

doi = "10.1016/j.clim.2023.109688",

language = "אנגלית",

volume = "253",

journal = "Clinical Immunology",

issn = "1521-6616",

publisher = "Academic Press Inc.",

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Chitnis, T, Foley, J, Ionete, C, El Ayoubi, NK, Saxena, S, Gaitan-Walsh, P, Lokhande, H, Paul, A, Saleh, F, Weiner, H, Qureshi, F, Becich, MJ, da Costa, FR, Gehman, VM, Zhang, F, Keshavan, A, Jalaleddini, K, Ghoreyshi, A & Khoury, SJ 2023, 'Clinical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis', Clinical Immunology, vol. 253, 109688. https://doi.org/10.1016/j.clim.2023.109688

TY - JOUR

T1 - Clinical validation of a multi-protein, serum-based assay for disease activity assessments in multiple sclerosis

AU - Chitnis, Tanuja

AU - Foley, John

AU - Ionete, Carolina

AU - El Ayoubi, Nabil K.

AU - Saxena, Shrishti

AU - Gaitan-Walsh, Patricia

AU - Lokhande, Hrishikesh

AU - Paul, Anu

AU - Saleh, Fermisk

AU - Weiner, Howard

AU - Qureshi, Ferhan

AU - Becich, Michael J.

AU - da Costa, Fatima Rubio

AU - Gehman, Victor M.

AU - Zhang, Fujun

AU - Keshavan, Anisha

AU - Jalaleddini, Kian

AU - Ghoreyshi, Ati

AU - Khoury, Samia J.

PY - 2023/8

Y1 - 2023/8

N2 - 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.

AB - 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.

KW - Clinical validation

KW - Gadolinium-positive lesion

KW - MS disease activity

KW - Multiple sclerosis

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U2 - 10.1016/j.clim.2023.109688

DO - 10.1016/j.clim.2023.109688

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C2 - 37414379

AN - SCOPUS:85164441029

SN - 1521-6616

VL - 253

JO - Clinical Immunology

JF - Clinical Immunology

M1 - 109688

ER -

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

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Keywords

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