Journal
MULTIPLE SCLEROSIS JOURNAL
Volume 22, Issue 9, Pages 1174-1183Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/1352458515615225
Keywords
Multiple sclerosis; progressive multifocal leukoencephalopathy (PML); magnetic resonance imaging (MRI); natalizumab; pharmacovigilance
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Funding
- ECTRIMS-MAGNMIS
- Beijing Nova Program [xx2013045]
- National Science Foundation of China [81101038]
- Key Projects in the National Science & Technology Pillar Program [2012BAI10B04]
- Stichting voor MS Research (Voorschoten, The Netherlands) [14-358e]
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Background: 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). Objective: 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. Methods: 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. Results: 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. Conclusion: 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.
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