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The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
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A case for gender-based approach to multiple sclerosis therapeutics.

Maria K Houtchens1, Riley Bove2

  • 1Women's Health Program, Partners MS Center, 60 Fenwood Road, Boston, MA 02115, USA.

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|July 25, 2018
PubMed
Summary

Sex differences in multiple sclerosis (MS) treatments are underexplored. Clinical trials for disease-modifying therapies (DMTs) lack sex-specific analyses, hindering optimal safety and efficacy for diverse patient populations.

Keywords:
Clinical trialsDisease modifying therapiesGenderHormonesMultiple sclerosisSexSex differences

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Area of Science:

  • Neurology
  • Clinical Pharmacology
  • Immunology

Background:

  • Established sex differences exist in multiple sclerosis (MS) risk and disease course.
  • Current understanding of sex-specific efficacy and toxicity of MS therapies remains limited.
  • Potential for sex-specific therapeutic strategies in MS is underexplored.

Purpose of the Study:

  • To systematically review published sex differences in Phase III pivotal trials for MS disease-modifying therapies (DMTs).
  • To evaluate baseline characteristics, efficacy, and safety outcomes stratified by sex.
  • To assess the landscape of hormonal therapies investigated for MS.

Main Methods:

  • Systematic review of Phase III clinical trials for FDA/EMA-approved MS DMTs.
  • Inclusion of data from pharmaceutical companies regarding sex-specific analyses.
  • Review of trials investigating hormonal interventions in MS.

Main Results:

  • No Phase III trials performed baseline sex-specific analyses or were powered for menopausal populations.
  • Some recent trials included pre-specified or post-hoc sex-stratified outcome analyses.
  • Limited trials focused on sex-specific hormonal interventions for MS.

Conclusions:

  • There is a critical need for adequately powered, pre-specified analyses accounting for sex and age in MS clinical trials.
  • Such analyses are essential to optimize the safety and efficacy of DMTs in specific patient populations.
  • Further research into sex-specific therapeutic approaches, including hormonal therapies, is warranted.