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Pulse monthly steroids during an elective interruption of natalizumab: a post-marketing study
G Borriello1, L Prosperini, C Mancinelli
1Department of Neurology and Psychiatry, Sapienza University, Rome, Italy.
Background And Purpose:
Temporary discontinuation of natalizumab is sometimes considered as the observed risk of progressive multifocal leukoencephalopathy (PML) in patients with multiple sclerosis (MS). However, interruption of natalizumab may result in a re-start of disease activity.
Methods:
In this prospective post-marketing study, 23 patients with MS treated with natalizumab elected a trial of treatment interruption (90-150 days) because of safety concerns on the risk of developing PML. To reduce the risk of disease activity return, patients received monthly intravenous (i.v.) steroid pulses before natalizumab re-start.
Results:
Despite the steroid coverage, seven patients (30.4%) had an active scan during the natalizumab interruption period; of these, four also had a concomitant clinical exacerbation.
Conclusions:
Our findings suggest that i.v. steroids are not currently recommendable as drug coverage during a scheduled treatment interruption period.
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