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Natalizumab: safety and risk in patients with relapsing-remitting multiple sclerosis
  1. Belén Rodríguez de Castro,
  2. Cristina Martinez-Múgica Barbosa,
  3. Aitor Ayastuy Ruiz,
  4. Beatriz Fernández González
  1. Pharmacy Department, Hospital Universitario Cabueñes, Gijón, Spain
  1. Correspondence to Belén Rodríguez de Castro, Hospital Universitario Cabueñes, Gijón 33394, Spain; b.rocas23{at}gmail.com

Abstract

Objective To estimate the risk of progressive multifocal leukoencephalopathy (PML) and the safety of natalizumab administration in patients with relapsing-remitting multiple sclerosis (RRMS).

Methods A descriptive retrospective observational study including all patients with RRMS treated with natalizumab followed-up after 10 years.The likelihood of developing PML was estimated based on three risk factors: anti-John Cunningham virus antibody index, previous immunosuppressive therapy, and duration of treatment. Patients were classified into five categories: minimum probability (<0.1/1000); low (0.1/1000); medium-low (0.2–0.6/1000); medium-high (0.8–3/1000); high probability (3–10/1000).

Results 34 patients were included. The probability of PML in the last cycle was: 55.9% minimum, 8.8% low, 11.8% medium-low, 3% medium-high, and 20.5% high. 12 patients continue with active treatment with natalizumab. No cases of PML have been confirmed. Adverse effects were detected in 50% of patients.

Conclusions Quantifying risk factors allows us to estimate the probability of PML appearance, thus assessing the maintenance or suspension of natalizumab.

  • natalizumab
  • multiple sclerosis
  • progressive multifocal leukoencephalopathy
  • safety
  • risk factor
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