title: Efficacy and tolerability of dimethyl fumarate in White-, African- and Hispanic- Americans with multiple sclerosis.
abstract: BACKGROUND
  Dimethyl fumarate (DMF) was approved by the US Food and Drug Administration (FDA) for treatment of relapsing-remitting multiple sclerosis (RRMS) based on two phase III randomized clinical trials (RCTs). There were not enough non-White patients enrolled in these RCTs to allow for subgroup analysis based on race. Efficacy and tolerability of DMF therapy across various racial groups is unknown.
  
  
  METHODS
  Retrospective chart review was performed on all patients with RRMS who were started on DMF in two tertiary multiple sclerosis (MS) clinics. Efficacy and tolerability of DMF was compared across three self-identified racial groups: White-American (WA), African-American (AA) and Hispanic-American (HA).
  
  
  RESULTS
  A total of 390 RRMS patients were included in the study: 261 (66.9%) WA, 69 (17.7%) AA and 52 (13.3%) HA. When comparing 'pre-DMF' (1 year) and 'on DMF' (mean follow up of 14 months) periods, statistically significant reduction in rates of annualized relapses (WA from 0.44 to 0.19, AA from 0.39 to 0.15, and HA from 0.39 to 0.14; no differences between groups), new T2 lesions (WA from 45% to 23%, AA from 39% to 23%, HA from 52% to 26%; no difference between groups), and Gd+ lesions (WA from 25% to 13%, AA from 24% to 7%, HA from 23% to 12%; no difference between groups) were seen. DMF was relatively well tolerated across all groups, with an overall discontinuation rate of 20% (no difference between the three groups).
  
  
  CONCLUSIONS
  Efficacy of DMF in our clinic population did not differ across three major ethnic groups, WA, AA and HA, and was comparable with results observed in the pivotal studies. These 'real-life' data suggest that race is not a factor that needs to be taken into account when initiating DMF.
authors: NYU Multiple Sclerosis Comprehensive Care Center, 240 East 38 Street, New York, NY 10016, USA.
authors: Lana
authors: L
authors: Zhovtis Ryerson
authors: NYU Multiple Sclerosis Care Center, NYU Langone Medical Center, New York, NY, USA.
authors: Rivka
authors: R
authors: Green
authors: NYU Multiple Sclerosis Care Center, NYU Langone Medical Center, New York, NY, USA.
authors: Gladyne
authors: G
authors: Confident
authors: Barnabas Multiple Sclerosis Care Center, Livingston, NJ, USA.
authors: Krupa
authors: K
authors: Pandey
authors: Barnabas Multiple Sclerosis Care Center, Livingston, NJ, USA.
authors: Benjamin
authors: B
authors: Richter
authors: NYU Multiple Sclerosis Care Center, NYU Langone Medical Center, New York, NY, USA.
authors: Tamar
authors: T
authors: Bacon
authors: NYU Multiple Sclerosis Care Center, NYU Langone Medical Center, New York, NY, USA.
authors: Carrie
authors: C
authors: Sammarco
authors: NYU Multiple Sclerosis Care Center, NYU Langone Medical Center, New York, NY, USA.
authors: Lisa
authors: L
authors: Laing
authors: NYU Multiple Sclerosis Care Center, NYU Langone Medical Center, New York, NY, USA.
authors: Jennifer
authors: J
authors: Kalina
authors: NYU Multiple Sclerosis Care Center, NYU Langone Medical Center, New York, NY, USA.
authors: Ilya
authors: I
authors: Kister
keywords: Annualized relapse rate; Dimethyl Fumarate; Multiple Sclerosis; Race