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Editorial |

Does Natalizumab Therapy Benefit Patients With Multiple Sclerosis?

Olaf Stüve, MD, PhD1,2,3,4; Gary R. Cutter, PhD5
[+] 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.
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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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Figure.
Patients With Multiple Sclerosis Experience a Meaningful Reduction in Disease Activity During Natalizumab Therapy

It is unknown whether beneficial effects of natalizumab are sustained in the long term (A), whether reactivation of disease after discontinuation results in neurologic disability similar to that of untreated patients (B), or whether eventually there is increased disease progression (C). The black line represents no treatment, and the red line represents natalizumab treatment.

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