Pulse monthly steroids during an elective interruption of natalizumab: a post-marketing study

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...

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Published in:European journal of neurology Vol. 19; no. 5; pp. 783 - 787
Main Authors: Borriello, G., Prosperini, L., Mancinelli, C., Giannì, C., Fubelli, F., Pozzilli, C.
Format: Journal Article
Language:English
Published: Oxford, UK Blackwell Publishing Ltd 01.05.2012
John Wiley & Sons, Inc
Subjects:
Adult
Antibodies, Monoclonal, Humanized - therapeutic use
Clinical trials
Disability Evaluation
Drugs
Female
Humans
Immunologic Factors - therapeutic use
Intravenous administration
Magnetic Resonance Imaging
Male
Middle Aged
Multiple sclerosis
Multiple Sclerosis - drug therapy
Natalizumab
observational study
Product Surveillance, Postmarketing
Progressive multifocal leukoencephalopathy
Prospective Studies
rebound
Retrospective Studies
Risk assessment
Severity of Illness Index
Statistics, Nonparametric
Steroid hormones
Steroids
ISSN:1351-5101, 1468-1331, 1468-1331
Online Access:Get full text
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Summary: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. Click here to view the accompanying paper in this issue.
Bibliography:ArticleID:ENE3577
istex:14E5AC9FACB14A06EC7AFCB8E83D5C0ACE7FC336
ark:/67375/WNG-6F3XZ7GD-6
See editorial by West et al., on page 663.
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ISSN:1351-5101
1468-1331
1468-1331
DOI:10.1111/j.1468-1331.2011.03577.x