title: Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses.
abstract: BACKGROUND
  The disease characteristics of multiple sclerosis (MS) appear to differ between Hispanic and Caucasian patients, with Hispanic patients having a younger age at onset, and a higher prevalence of optic nerve and spinal cord involvement. Fingolimod, the first-in-class oral sphingosine 1-phosphate receptor modulator approved for the treatment of relapsing MS, has been shown to significantly reduce annualized relapse rates (ARRs), lesion-based magnetic resonance imaging (MRI) activity, confirmed disability, and brain volume loss, compared with placebo or intramuscular interferon beta-1a (IFNβ-1a IM) in randomized, double-blind, controlled clinical studies. Here, the efficacy and safety profile of fingolimod in Hispanic patients was compared to that observed in the overall study populations.
  
  
  METHODS
  This was a post hoc analysis of relapses and safety data for Hispanic patients with relapsing-remitting MS (RRMS) randomized to receive daily fingolimod 0.5 mg, weekly IFNβ-1a IM (30 mg) or placebo, in the phase 3, controlled FREEDOMS, FREEDOMS II, and TRANSFORMS fingolimod studies. The ARR was estimated for each treatment group; only relapses that were confirmed by an independent examining neurologist were included in these analyses. Safety assessments included the incidence of adverse events and serious adverse events.
  
  
  RESULTS
  Eligible Hispanic patients aged 18-55 years (n=181) had been treated as follows: fingolimod 0.5 mg (n=89), IFNβ-1a IM (n=65), and placebo (n=27). Hispanic patients treated with fingolimod for up to 2 years had lower ARRs (ARR: 0.22, 95% confidence interval [CI]: 0.14-0.35) than those receiving placebo (ARR: 0.46, 95% CI: 0.24-0.88) or IFNβ-1a IM (ARR: 0.34, 95% CI: 0.18-0.63), with relative reductions of 52% and 35%, respectively. A transient decrease in heart rate that started to attenuate 6 h after fingolimod administration was observed, consistent with the well-characterized pharmacologic effect following fingolimod treatment initiation. No cases of symptomatic bradycardia were reported in Hispanic patients. The incidence of first-degree atrioventricular block was low and similar across all treatment groups (3.1-4.5%). The safety profile of fingolimod in Hispanic patients was consistent with that reported in the overall population of each study.
  
  
  CONCLUSIONS
  Overall, this study demonstrates that fingolimod is efficacious and well tolerated in Hispanic patients with RRMS.
authors.affiliation: San Juan MS Center, Guaynabo, PR, USA, achinea@me.com.
authors.forename: Angel R
authors.initials: AR
authors.lastname: Chinea Martinez
authors.forename: Jorge
authors.initials: J
authors.lastname: Correale
authors.forename: Patricia K
authors.initials: PK
authors.lastname: Coyle
authors.forename: Xiangyi
authors.initials: X
authors.lastname: Meng
authors.forename: Nadia
authors.initials: N
authors.lastname: Tenenbaum
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D016903:Drug Monitoring; D005260:Female; D000068876:Fingolimod Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects; D006630:Hispanic or Latino; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D000068556:Interferon beta-1a / Q000008:administration & dosage / Q000009:adverse effects; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068876:Fingolimod Hydrochloride; D000068556:Interferon beta-1a