title: Efficacy of natalizumab therapy in patients of African descent with relapsing multiple sclerosis: analysis of AFFIRM and SENTINEL data.
abstract: BACKGROUND
  Patients with multiple sclerosis (MS) who are of African descent experience a more aggressive disease course than patients who are of white race/ethnicity. In phase 3 clinical trials (Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis [AFFIRM] and Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis [SENTINEL]), natalizumab use significantly improved clinical and magnetic resonance imaging outcomes over 2 years in patients with relapsing MS. Because patients of African descent may be less responsive to interferon beta treatment than patients of white race/ethnicity, the efficacy of natalizumab therapy in this population is clinically important.
  
  
  OBJECTIVE
  To evaluate the efficacy of natalizumab use in patients of African descent with relapsing MS.
  
  
  METHODS
  Post hoc analysis.
  
  
  METHODS
  Academic research.
  
  
  METHODS
  Patients of African descent with relapsing MS who received natalizumab or placebo in the phase 3 AFFIRM study and those who received natalizumab plus intramuscular interferon beta-1a or placebo plus intramuscular interferon beta-1a in the phase 3 SENTINEL study.
  
  
  METHODS
  Efficacy of natalizumab use in patients of African descent with relapsing MS who participated in the AFFIRM or SENTINEL trial.
  
  
  RESULTS
  Forty-nine patients of African descent participated in AFFIRM (n = 10) or SENTINEL (n = 39). Demographic and baseline disease characteristics were similar between patients treated with natalizumab (n = 21) or placebo (n = 28). Natalizumab therapy significantly reduced the annualized MS relapse rate by 60% (0.21 vs 0.53 in the placebo group, P = .02). Compared with placebo use, natalizumab therapy also significantly reduced the accumulation of lesions observed on magnetic resonance imaging over 2 years: the mean number of gadolinium-enhancing lesions was reduced by 79% (0.19 vs 0.91, P = .03), and the mean number of new or enlarged T2-weighted lesions was reduced by 90% (0.88 vs 8.52, P = .008).
  
  
  CONCLUSIONS
  Natalizumab therapy significantly improved the relapse rate and accumulation of brain lesions in patients of African descent with relapsing MS.
authors.affiliation: UCSF Multiple Sclerosis Center, Department of Neurology, University of California, San Francisco, 94117, USA. bruce.cree@ucsf.edu
authors.forename: Bruce A C
authors.initials: BA
authors.lastname: Cree
authors.forename: William H
authors.initials: WH
authors.lastname: Stuart
authors.forename: Carlo S
authors.initials: CS
authors.lastname: Tornatore
authors.forename: Douglas R
authors.initials: DR
authors.lastname: Jeffery
authors.forename: Amy L
authors.initials: AL
authors.lastname: Pace
authors.forename: Choon H
authors.initials: CH
authors.lastname: Cha
mesh_terms: D000328:Adult; D001741:Black or African American / Q000208:ethnology*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000208:ethnology*; D000069442:Natalizumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab; D016899:Interferon-beta; D000068556:Interferon beta-1a