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

  • Jagannadha Avasarala (a1)

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.

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Copyright

Corresponding author

*Address for correspondence: Jagannadha Avasarala, MD, PhD, Department of Neurology, University of Kentucky Medical Center, 740 S Limestone, J 401, Lexington, KY 40536, USA. (Email: javasarala@uky.edu)

References

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1. Kister, I, Chamot, E, Bacon, JH, Niewczyk, PM, De Guzman, RA, Apatoff, B, et al. Rapid disease course in African Americans with multiple sclerosis. Neurology. 2010; 75(3): 217223.
2. Buchanan, RJ, Wang, S, Huang, C, Graber, D. Profiles of nursing home residents with multiple sclerosis using the minimum data set. Mult Scler. 2001; 7(3): 189200.
3. Avasarala, J. Inadequacy of clinical trial designs and data to control for the confounding impact of race/ethnicity in response to treatment in multiple sclerosis. JAMA Neurol. 2014; 71(8): 943944.
4. Kappos, L, Wiendl, H, Selmaj, K, et al. Daclizumab HYP versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2015; 373(15): 14181428.
5. Hauser, SL, Bar-Or, A, Comi, G, et al. Ocrelizumab versus interferon beta-1a in relapsing multiple sclerosis. N Engl J Med. 2017; 376(3): 221234.
6. Montalban, X, Hauser, SL, Kappos, L, et al. Ocrelizumab versus placebo in primary progressive multiple sclerosis. N Engl J Med. 2017; 376(3): 209220.

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