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Research ArticleAdult Brain
Open Access

Feasibility of Brain Atrophy Measurement in Clinical Routine without Prior Standardization of the MRI Protocol: Results from MS-MRIUS, a Longitudinal Observational, Multicenter Real-World Outcome Study in Patients with Relapsing-Remitting MS

R. Zivadinov, N. Bergsland, J.R. Korn, M.G. Dwyer, N. Khan, J. Medin, J.C. Price, B. Weinstock-Guttman and D. Silva on behalf of the MS-MRIUS Study Group
American Journal of Neuroradiology February 2018, 39 (2) 289-295; DOI: https://doi.org/10.3174/ajnr.A5442
R. Zivadinov
aFrom the Department of Neurology (R.Z., N.B., M.G.D.), Buffalo Neuroimaging Analysis Center
cTranslational Imaging Center at Clinical and Translational Science Institute (R.Z.), University of Buffalo, State University of New York, Buffalo, New York
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N. Bergsland
aFrom the Department of Neurology (R.Z., N.B., M.G.D.), Buffalo Neuroimaging Analysis Center
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J.R. Korn
dQuintilesIMS (J.R.K.), Burlington, Massachusetts
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M.G. Dwyer
aFrom the Department of Neurology (R.Z., N.B., M.G.D.), Buffalo Neuroimaging Analysis Center
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N. Khan
eQuintilesIMS (N.K., J.C.P.), Basel, Switzerland
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J. Medin
fNovartis Pharmaceuticals AG (J.M., D.S.), Basel, Switzerland.
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J.C. Price
eQuintilesIMS (N.K., J.C.P.), Basel, Switzerland
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B. Weinstock-Guttman
bDepartment of Neurology (B.W.-G.), Jacobs Multiple Sclerosis Center, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, New York
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D. Silva
fNovartis Pharmaceuticals AG (J.M., D.S.), Basel, Switzerland.
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Article Figures & Data

Tables

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    Table 1:

    Demographic and clinical characteristics of the study subjects according to the MRI scanner changes between the index and postindex periodsa

    Index VariablesTotal Patients with RRMS (n = 590)Patients with RRMS with MRI Scanner Changes (n = 309)Patients with RRMS without MRI Scanner Changes (n = 281)P Valueb
    Age at index in yr (median) (IQR)42 (36; 49)41 (35; 48)44 (37; 51).007
    Women (No.) (%)464 (78.6)247 (79.9)217 (77.2).422
    Race/ethnicity (No.) (%)
        Caucasian/white494 (83.7)252 (81.6)242 (86.1).319
        Non-Caucasian63 (10.7)37 (12.0)26 (9.3)
        Unknown33 (5.6)20 (6.5)13 (4.6)
    Body mass index at index (median) (IQR)26.6 (23.2–30.6)26.5 (23.3–30.4)26.6 (23–30.9).895
    Disease duration in yr (median) (IQR)8 (4; 13)7 (4; 12)8 (4; 13).148
    Number with relapse in 2 yr before index (No.) (%)236 (40.0)143 (46.3)93 (33.1).003
    EDSS at index (median) (IQR)2.0 (1.0–3.0)2.0 (1.0–3.0)2.5 (1.5–3.5).002
    Use of DMT 2 yr before index (No.) (%)
        Teriflunomide5 (0.9)3 (1)2 (0.7).749
        Glatiramer acetate175 (30.8)87 (28.9)88 (32.8).310
        Interferon-β317 (55.7)175 (58.1)142 (53).217
        Alemtuzumab1 (0.2)1 (0.3)0 (0).345
        Dimethyl fumarate38 (6.7)21 (7)17 (6.3).763
        No DMT94 (15.9)46 (14.9)48 (17.1).467
    • Note:—EDSS indicates Expanded Disability Status Scale; IQR, interquartile range; DMT, disease-modifying treatment.

    • ↵a MRI changes include hardware/software/coil/protocol differences between the index and postindex.

    • ↵b P values represent group comparisons of patients with MS with and without MRI changes during the follow-up derived with the Student t, χ2, and Mann-Whitney rank sum tests as appropriate.

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    Table 2:

    Brain atrophy measures of the study subjects between index and postindex, according to MRI changesa

    Total Patients with RRMSPatients with RRMS with MRI Software/Coil/Protocol ChangesPatients with RRMS without MRI Software/Coil/Protocol ChangesP Valueb
    PBVC on 2D-T1WIn = 259n = 89n = 170.233
    −0.31 (−0.74–0.13)−0.35 (−0.97–0.11)−0.28 (−0.67–0.14)
    PBVC on 3D-T1WIn = 110n = 37n = 73.740
    −0.38 (−0.88 to −0.04)−0.38 (−0.93–0.02)−0.37 (−0.81 to −0.08)
    PLVVC on 2D-T1WIn = 257n = 89n = 168.848
    0.95 (−1.77–3.99)0.95 (−1.92–4.1)0.96 (−1.63–3.94)
    PLVVC on 3D-T1WIn = 110n = 37n = 73.940
    1.47 (−1.26–4.39)1.5 (−1.36–4.15)1.01 (−1.17–4.46)
    PLVVC on T2-FLAIRn = 388n = 130n = 258.179
    0.90 (−2.91–5.94)0.21 (−4.67–7.2)1.1 (−2.1–5.51)
    PLVVC on T2-FLAIRcn = 554n = 291n = 263.007
    0.51 (−3.95–6.01)−0.31 (−6.4–6.9)1.13 (−2.15–5.53)
    • ↵a PBVC and PLVVC on 2D-, 3D-T1WI and T2-FLAIR were obtained in patients with software/coil/protocol scanner changes. All values in the table are presented as the number of patients for a particular analysis, median, and interquartile range. The longitudinal follow-up values are annualized.

    • ↵b P values represent patients with MS with and without MRI changes during the follow-up group comparisons and were derived using analysis of covariance adjusted for age, sex, days between index and postindex, and baseline volume as appropriate.

    • ↵c PLVVC on T2-FLAIR was performed in patients with hardware/software/coil/protocol changes.

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American Journal of Neuroradiology: 39 (2)
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R. Zivadinov, N. Bergsland, J.R. Korn, M.G. Dwyer, N. Khan, J. Medin, J.C. Price, B. Weinstock-Guttman, D. Silva
Feasibility of Brain Atrophy Measurement in Clinical Routine without Prior Standardization of the MRI Protocol: Results from MS-MRIUS, a Longitudinal Observational, Multicenter Real-World Outcome Study in Patients with Relapsing-Remitting MS
American Journal of Neuroradiology Feb 2018, 39 (2) 289-295; DOI: 10.3174/ajnr.A5442

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Feasibility of Brain Atrophy Measurement in Clinical Routine without Prior Standardization of the MRI Protocol: Results from MS-MRIUS, a Longitudinal Observational, Multicenter Real-World Outcome Study in Patients with Relapsing-Remitting MS
R. Zivadinov, N. Bergsland, J.R. Korn, M.G. Dwyer, N. Khan, J. Medin, J.C. Price, B. Weinstock-Guttman, D. Silva
American Journal of Neuroradiology Feb 2018, 39 (2) 289-295; DOI: 10.3174/ajnr.A5442
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