4.7 Article

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

Journal

EUROPEAN JOURNAL OF NEUROLOGY
Volume 19, Issue 5, Pages 783-787

Publisher

WILEY
DOI: 10.1111/j.1468-1331.2011.03577.x

Keywords

magnetic resonance imaging; multiple sclerosis; natalizumab; observational study; progressive multifocal leukoencephalopathy; rebound; steroids

Funding

  1. Sanofi-Aventis
  2. Merck Serono
  3. Bayer Schering

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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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