Pulse monthly steroids during an elective interruption of natalizumab: a post-marketing study.
Author(s): Borriello G, Prosperini L, Mancinelli C, Gianni C, Fubelli F, Pozzilli C
Affiliation(s): Multiple Sclerosis Centre, S. Andrea Hospital, Department of Neurology and Psychiatry, Sapienza University, Rome, Italy.
Publication date & source: 2011-11-07, Eur J Neurol., [Epub ahead of print]
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. (c) 2011 The Author(s). European Journal of Neurology (c) 2011 EFNS.
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