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

Eur J Neurol. 2012 May;19(5):783-7. doi: 10.1111/j.1468-1331.2011.03577.x. Epub 2011 Nov 7.

Abstract

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.

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Disability Evaluation
  • Female
  • Humans
  • Immunologic Factors / therapeutic use*
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Multiple Sclerosis / drug therapy*
  • Natalizumab
  • Product Surveillance, Postmarketing*
  • Prospective Studies
  • Retrospective Studies
  • Severity of Illness Index
  • Statistics, Nonparametric

Substances

  • Antibodies, Monoclonal, Humanized
  • Immunologic Factors
  • Natalizumab