FDA-approved drugs for multiple sclerosis have no efficacy or disability data in non-Caucasian patients

CNS Spectr. 2019 Jun;24(3):279-280. doi: 10.1017/S1092852918001517. Epub 2019 Jan 3.

Abstract

Pharmacotherapy of multiple sclerosis (MS) is evolving rapidly. Despite impressive gains over the past 2 decades in the approval of multiple drugs for MS, lack of recruitment of minorities with MS in phase 3 clinical studies is a persistent concern and skews efficacy and disability data.

Keywords: African-American MS; FDA; clinical trials; disability; disease modifying drugs; post-marketing data analysis.

Publication types

  • Editorial

MeSH terms

  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Black or African American*
  • Daclizumab / adverse effects*
  • Daclizumab / therapeutic use
  • Humans
  • Multiple Sclerosis / drug therapy*
  • Product Surveillance, Postmarketing / standards*
  • Product Surveillance, Postmarketing / statistics & numerical data
  • Selection Bias
  • United States
  • United States Food and Drug Administration / standards

Substances

  • Antibodies, Monoclonal, Humanized
  • ocrelizumab
  • Daclizumab