title: Impact of natalizumab on cognitive performances and fatigue in relapsing multiple sclerosis: a prospective, open-label, two years observational study.
abstract: OBJECTIVE
  Natalizumab reduces the relapse rate and magnetic resonance imaging activity in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). So far the influence of natalizumab on cognitive functions and fatigue in MS remains uncertain. The aim of this prospective, open-label, observational study was to evaluate the possible effects of natalizumab on cognition and fatigue measures in RRMS patients treated for up to two years.
  
  
  METHODS
  Cognitive performances were examined by the Rao's Brief Repeatable Battery (BRB), the Stroop test (ST) and the Cognitive Impairment Index (CII), every 12 months. Patients who failed in at least 3 tests of the BRB and the ST were classified as cognitively impaired (CI). Fatigue Severity Scale (FSS) was administered every 12 months to assess patient's self-reported fatigue. One hundred and 53 patients completed 1 and 2 year-natalizumab treatment, respectively.
  
  
  RESULTS
  After 1 year of treatment the percentage of CI patients decreased from 29% (29/100) at baseline to 19% (19/100) (p = 0.031) and the mean baseline values of CII (13.52±6.85) and FSS (4.01±1.63) scores were significantly reduced (10.48±7.12, p<0.0001 and 3.61±1.56, p = 0.008). These significant effects were confirmed in the subgroup of patients treated up to two years.
  
  
  CONCLUSIONS
  These results demonstrate that a short-term NTZ treatment may significantly improve cognitive performances and fatigue in RRMS patients.
authors.affiliation: Department of Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Iaffaldano
authors.forename: Rosa Gemma
authors.initials: RG
authors.lastname: Viterbo
authors.forename: Damiano
authors.initials: D
authors.lastname: Paolicelli
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Lucchese
authors.forename: Emilio
authors.initials: E
authors.lastname: Portaccio
authors.forename: Benedetta
authors.initials: B
authors.lastname: Goretti
authors.forename: Vita
authors.initials: V
authors.lastname: Direnzo
authors.forename: Mariangela
authors.initials: M
authors.lastname: D'Onghia
authors.forename: Stefano
authors.initials: S
authors.lastname: Zoccolella
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Amato
authors.forename: Maria
authors.initials: M
authors.lastname: Trojano
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects; D004334:Drug Administration Schedule; D005221:Fatigue / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D000069442:Natalizumab; D009483:Neuropsychological Tests; D011446:Prospective Studies; D012008:Recurrence; D012720:Severity of Illness Index
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab