title: Pulse monthly steroids during an elective interruption of natalizumab: a post-marketing study.
abstract: OBJECTIVE
  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.
authors: Department of Neurology and Psychiatry, Sapienza University, Rome, Italy.
authors: G
authors: G
authors: Borriello
authors: L
authors: L
authors: Prosperini
authors: C
authors: C
authors: Mancinelli
authors: C
authors: C
authors: Giannì
authors: F
authors: F
authors: Fubelli
authors: C
authors: C
authors: Pozzilli
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D000069442:Natalizumab; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012189:Retrospective Studies; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069442:Natalizumab