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Update on estimated PML risk related to fingolimod

MS Virtual 2020
An updated estimate on the global risk of progressive multifocal leukoencephalopathy (PML) in 299,600 MS patients receiving fingolimod showed that the PML risk associated with fingolimod is low, estimated at 0.13 per 1,000 patients over a 5-year period[1]. The risk appears to increase with cumulative exposure. PML risk could be increased if fingolimod treatment is started at a relatively high age. Potential PML cases from the manufacturer's safety database (data cut-off 28 February 2020) were reviewed by an independent PML adjudication committee. The number of confirmed PML cases was compared with the estimated global number of fingolimod-treated patients and patient-years of exposure. Approximately 299,600 patients were treated with fingolimod globally, covering >778,900 patient-years (PYs) of exposure. The number of suspected PML cases reported and evaluated was 188. Of these: 37 cases were associated with fingolim...

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