Diagnostic performance of brain MRI in pharmacovigilance of natalizumab-treated MS patients

作者：Wattjes, Mike P.^*; Wijburg, Martijn T.; Vennegoor, Anke; Witte, Birgit I.; Roosendaal, Stefan D.; Sanchez, Esther; Liu, Yaou; Jarnalo, Carine O. Martins; Richert, Nancy D.; Uitdehaag, Bernard M. J.; Barkhof, Frederik; Killestein, Joep

来源：Multiple Sclerosis, 2016, 22(9): 1174-1183.

DOI：10.1177/1352458515615225

• Multiple sclerosis
• progressive multifocal leukoencephalopathy (PML)
• magnetic resonance imaging (MRI)
• natalizumab
• pharmacovigilance

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.

• 出版日期2016-8
• 单位首都医科大学