title: A comparison of multiple sclerosis clinical disease activity between patients treated with natalizumab and fingolimod.
abstract: BACKGROUND
  Natalizumab and fingolimod were approved for treatment of active relapsing-remitting multiple sclerosis (RRMS) in Denmark in 2006 and 2011, respectively. There have been no randomized head-to-head studies comparing the two drugs.
  
  
  OBJECTIVE
  To compare the clinical efficacy of natalizumab and fingolimod.
  
  
  METHODS
  Data on all Danish RRMS patients who started their first second-line treatment with natalizumab or fingolimod from July 2011 to March 2015 were prospectively recorded in the Danish Multiple Sclerosis (MS) Treatment Register. The two treatment arms were 1:1 propensity score matched by baseline covariates using 'nearest neighbour' method.
  
  
  RESULTS
  Propensity score matching left 928 of 1309 RRMS cases, 464 in each treatment group. The on-treatment annualized relapse rate was 0.296 (95% confidence interval (CI): 0.26-0.34) for natalizumab and 0.307 (95% CI: 0.27-0.35) for fingolimod. The adjusted relapse rate ratio was 0.93 (95% CI: 0.74-1.17; p = 0.53). Mean time to first relapse was 2.55 and 2.56 years, respectively ( p = 0.76). There was no difference in change of Expanded Disability Status Scale (EDSS).
  
  
  CONCLUSIONS
  We found no differences in clinical disease activity between natalizumab- and fingolimod-treated RRMS patients in this real-life observational study. However, the lack of magnetic resonance imaging (MRI) data for the propensity score matching may conceal a higher efficacy of natalizumab.
authors.affiliation: Department of Clinical Epidemiology, Clinical Institute, Aarhus University, Aarhus, Denmark/The Danish Multiple Sclerosis Registry, Neuroscience Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Nils
authors.initials: N
authors.lastname: Koch-Henriksen
authors.affiliation: The Danish Multiple Sclerosis Registry, Neuroscience Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark/The Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Melinda
authors.initials: M
authors.lastname: Magyari
authors.affiliation: The Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Finn
authors.initials: F
authors.lastname: Sellebjerg
authors.affiliation: The Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Per
authors.initials: P
authors.lastname: Soelberg Sørensen
mesh_terms: D000328:Adult; D018450:Disease Progression; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D000069442:Natalizumab / Q000627:therapeutic use*; D011446:Prospective Studies; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000069442:Natalizumab; D000068876:Fingolimod Hydrochloride
keywords: Multiple sclerosis; comparison; efficacy; fingolimod; natalizumab; relapsing remitting