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August 2014

Does Natalizumab Therapy Benefit Patients With Multiple Sclerosis?

Author Affiliations
  • 1Veterans Affairs Medical Center, Neurology Section, Medical Service Dallas, Veterans Affairs North Texas Health Care System, Dallas
  • 2Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center at Dallas
  • 3Department of Neurology, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany
  • 4Associate Editor, JAMA Neurology
  • 5Section on Research Methods and Clinical Trials, Department of Biostatistics, University of Alabama at Birmingham
JAMA Neurol. 2014;71(8):945-946. doi:10.1001/jamaneurol.2014.1201

Does natalizumab therapy benefit patients with multiple sclerosis (MS)? The obvious answer is yes. Natalizumab was approved for patients with relapsing forms of MS by regulatory agencies based on the results of 2 phase 3 clinical trials that showed substantial benefits with regard to clinical and paraclinical outcomes.1,2 Post hoc analyses suggest that many who adhere to natalizumab therapy have a high likelihood of being disease free for many years.3 Based on these efficacy data, patients should perhaps be treated with natalizumab indefinitely or until they seem to have transitioned to secondary progressive MS. However, shortly after its initial approval, it was determined that natalizumab use is associated with progressive multifocal encephalopathy (PML), an opportunistic infection of the central nervous system that is caused by the human polyomavirus John Cunningham virus (JCV).

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