TY - JOUR
T1 - Diagnostic performance of brain MRI in pharmacovigilance of natalizumab-treated MS patients
AU - Wattjes, Mike P.
AU - Wijburg, Martijn T.
AU - Vennegoor, Anke
AU - Witte, Birgit I.
AU - Roosendaal, Stefan D.
AU - Sanchez, Esther
AU - Liu, Yaou
AU - Martins Jarnalo, Carine O.
AU - Richert, Nancy D.
AU - Uitdehaag, Bernard M. J.
AU - Barkhof, Frederik
AU - Killestein, Joep
PY - 2016/8
Y1 - 2016/8
N2 - In natalizumab-treated multiple sclerosis (MS) patients, magnetic resonance imaging (MRI) is considered as a sensitive tool in detecting both MS disease activity and progressive multifocal leukoencephalopathy (PML). To investigate the performance of neuroradiologists using brain MRI in detecting new MS lesions and asymptomatic PML lesions and in differentiating between MS and PML lesions in natalizumab-treated MS patients. The secondary aim was to investigate interrater variability. In this retrospective diagnostic study, four blinded neuroradiologists assessed reference and follow-up brain MRI scans of 48 natalizumab-treated MS patients with new asymptomatic PML lesions (n = 21) or new MS lesions (n = 20) or no new lesions (n = 7). Sensitivity and specificity for detection of new lesions in general (MS and PML lesions), MS and PML lesion differentiation, and PML detection were determined. Interrater agreement was calculated. Overall sensitivity and specificity for the detection of new lesions, regardless of the nature of the lesions, were 77.4% and 89.3%, respectively; for PML-MS lesion differentiation, 74.2% and 84.7%, respectively; and for asymptomatic PML lesion detection, 59.5% and 91.7%, respectively. Interrater agreement for the tested categories was fair to moderate. The diagnostic performance of trained neuroradiologists using brain MRI in pharmacovigilance of natalizumab-treated MS patients is moderately good. Interrater agreement among trained readers is fair to moderate
AB - In natalizumab-treated multiple sclerosis (MS) patients, magnetic resonance imaging (MRI) is considered as a sensitive tool in detecting both MS disease activity and progressive multifocal leukoencephalopathy (PML). To investigate the performance of neuroradiologists using brain MRI in detecting new MS lesions and asymptomatic PML lesions and in differentiating between MS and PML lesions in natalizumab-treated MS patients. The secondary aim was to investigate interrater variability. In this retrospective diagnostic study, four blinded neuroradiologists assessed reference and follow-up brain MRI scans of 48 natalizumab-treated MS patients with new asymptomatic PML lesions (n = 21) or new MS lesions (n = 20) or no new lesions (n = 7). Sensitivity and specificity for detection of new lesions in general (MS and PML lesions), MS and PML lesion differentiation, and PML detection were determined. Interrater agreement was calculated. Overall sensitivity and specificity for the detection of new lesions, regardless of the nature of the lesions, were 77.4% and 89.3%, respectively; for PML-MS lesion differentiation, 74.2% and 84.7%, respectively; and for asymptomatic PML lesion detection, 59.5% and 91.7%, respectively. Interrater agreement for the tested categories was fair to moderate. The diagnostic performance of trained neuroradiologists using brain MRI in pharmacovigilance of natalizumab-treated MS patients is moderately good. Interrater agreement among trained readers is fair to moderate
KW - Multiple sclerosis
KW - magnetic resonance imaging (MRI)
KW - natalizumab
KW - pharmacovigilance
KW - progressive multifocal leukoencephalopathy (PML)
U2 - https://doi.org/10.1177/1352458515615225
DO - https://doi.org/10.1177/1352458515615225
M3 - Article
C2 - 26564995
SN - 1352-4585
VL - 22
SP - 1174
EP - 1183
JO - Multiple sclerosis (Houndmills, Basingstoke, England)
JF - Multiple sclerosis (Houndmills, Basingstoke, England)
IS - 9
ER -