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

Autor: Wattjes MP; Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands., Wijburg MT; Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands/Department of Neurology, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands., Vennegoor A; Department of Neurology, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands., Witte BI; Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands., Roosendaal SD; Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands/Department of Radiology, Erasmus Medical Center, Rotterdam, The Netherlands., Sanchez E; Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands., Liu Y; Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands/Department of Radiology, Xuanwu Hospital, Capital Medical University, Beijing, P. R. China., Martins Jarnalo CO; Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands/Department of Radiology, Medical Center Haaglanden, The Hague, The Netherlands., Richert ND; Multiple Sclerosis Clinical Development Group, Biogen, Cambridge, MA, USA., Uitdehaag BM; Department of Neurology, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands., Barkhof F; Department of Radiology and Nuclear Medicine, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands., Killestein J; Department of Neurology, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
Jazyk: angličtina
Zdroj: Multiple sclerosis (Houndmills, Basingstoke, England) [Mult Scler] 2016 Aug; Vol. 22 (9), pp. 1174-83. Date of Electronic Publication: 2015 Nov 12.
DOI: 10.1177/1352458515615225
Abstrakt: 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.
(© The Author(s), 2015.)
Databáze: MEDLINE