title: Long-term effectiveness and safety of natalizumab in a Portuguese population.
abstract: OBJECTIVE
  Natalizumab long-term effectiveness data in real-world relapsing-remitting multiple sclerosis (RRMS) is needed. Our objective is to report the long-term effectiveness and safety of natalizumab in a cohort of RRMS patients.
  
  
  METHODS
  This is a retrospective study of natalizumab treatment for two years or longer in RRMS. Annualized relapse rate, Expanded Disability Status Scale (EDSS), brain magnetic resonance imaging T2 lesion volume, JC virus antibody status, previous treatments and adverse events were analysed.
  
  
  RESULTS
  Seventy-one patients were included with a mean treatment duration of 44.86±17.39months. Over the treatment duration there was a significant decrease in annualized relapse rate (88.37%) and EDSS (28.57%); no evidence of clinical disease activity in 73.24% and 61.97% after one and two-years respectively; and brain magnetic resonance imaging T2 lesion volume remained stable. Forty patients suspended natalizumab, in 85% due to high risk of developing progressive multifocal leukoencephalopathy (PML). The major complication was PML (n=3).
  
  
  CONCLUSIONS
  Natalizumab showed effectiveness in the long-term follow up period of our cohort, with reduction of ARR, EDSS, and MRI lesion load stabilization. PML was the major complication.
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal. Electronic address: mcorreia.ines@gmail.com.
authors.forename: I
authors.initials: I
authors.lastname: Correia
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: S
authors.initials: S
authors.lastname: Batista
authors.affiliation: Department of Neuroradiology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: O
authors.initials: O
authors.lastname: Galego
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: I B
authors.initials: IB
authors.lastname: Marques
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: J
authors.initials: J
authors.lastname: Jesus-Ribeiro
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: A I
authors.initials: AI
authors.lastname: Martins
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: C
authors.initials: C
authors.lastname: Nunes
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: M C
authors.initials: MC
authors.lastname: Macário
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: L
authors.initials: L
authors.lastname: Cunha
authors.affiliation: Department of Neurology, Centro Hospitalar e Universitário de Coimbra, Portugal.
authors.forename: L
authors.initials: L
authors.lastname: Sousa
mesh_terms: D000293:Adolescent; D000328:Adult; D001921:Brain / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000473:pathology; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007968:Leukoencephalopathy, Progressive Multifocal / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D000069442:Natalizumab / Q000627:therapeutic use*; D011174:Portugal; D012189:Retrospective Studies; D012306:Risk; D028761:Withholding Treatment; D055815:Young Adult
chemical_list: D000069442:Natalizumab
keywords: Monoclonal antibodies; Multiple sclerosis; Natalizumab; Relapsing-remitting; Treatment outcome