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More time, more safety: is this the future optimal way for natalizumab treatment in multiple sclerosis?
  1. Pasquale Annunziata
  1. Department of Medicine, Surgery and Neurosciences, University of Siena, Siena 53100, Toscana, Italy
  1. Correspondence to Professor Pasquale Annunziata, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena 53100, Toscana, Italy; annunziata{at}

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Immune therapy of multiple sclerosis with monoclonal antibodies modulating the lymphocyte trafficking could require new treatment options

Natalizumab (NTZ) remains the first monoclonal antibody approved for immune therapy of multiple sclerosis (MS) exerting its activity through limitation of lymphocyte trafficking across blood–brain barrier endothelium. However, this underlying mechanism in front of an established clinical efficacy exposes the treatment to serious adverse event such as the occurrence of progressive multifocal leucoencephalopathy (PML). This risk has been linked to either circulating anti-JC virus (JCV) antibody level or to previous immunosuppressive treatments. A recent retrospective analysis of four previous NTZ clinical trials estimates the PML risk less than 0.07 per 1000 patients in anti-JCV antibody-negative patients rising to 1.7% in anti-JCV antibody-positive patients with no immunosuppressive treatment and to 2.7% in those previously receiving immunosuppressants. Moreover, the …

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  • Contributors PA is the sole author of this manuscript. He designed the work, analysed data, drafted the manuscript and approved the version to be published.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Commissioned; internally peer reviewed.

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