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Related Concept Videos

Multiple Sclerosis l: Introduction01:19

Multiple Sclerosis l: Introduction

Multiple sclerosis is a chronic autoimmune disease of the central nervous system (CNS) that affects the brain, spinal cord, and optic nerves. It is an inflammatory demyelinating disorder and a leading cause of neurological disability in young adults.EpidemiologyMS commonly begins between 20 and 40 years of age and is twice as common in women. Its exact cause remains unclear, but genetic susceptibility contributes, with higher risk in first-degree relatives and identical twins. A greater...

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The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
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Recurrent disability progression endpoints in multiple sclerosis clinical trials.

Alexandra Bühler1, Marcel Wolbers2, Fabian Model2

  • 1University of Waterloo, Waterloo, ON, Canada.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|September 30, 2022
PubMed
Summary

Analyzing recurrent disability progression events in multiple sclerosis (MS) trials offers a more complete picture of treatment effects. This recurrent event analysis improves statistical power and better captures long-term disability progression compared to traditional methods.

Keywords:
Ocrelizumabdisability progressiondisease-modifying therapymultiple sclerosisrecurrent event analysestreatment outcome

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Area of Science:

  • Clinical Trials Methodology
  • Biostatistics
  • Neurology

Background:

  • Current multiple sclerosis (MS) trials use time-to-first disability progression, ignoring subsequent events.
  • This standard endpoint may limit comprehensive assessment of treatment effects on disability accumulation.

Purpose of the Study:

  • To define recurrent disability progression events in MS.
  • To compare the efficacy of time-to-first event analysis versus recurrent event analysis.

Main Methods:

  • Defined recurrent disability progression events by extending the first event definition.
  • Compared marginal recurrent event models (negative binomial, Lin-Wei-Yang-Ying) with Cox regression.
  • Utilized data from relapsing MS (RMS) and primary progressive MS (PPMS) randomized controlled trials and simulated data.

Main Results:

  • Recurrent event analyses captured more progression events (+7.5-9.9% in RMS, +22.7% in PPMS) than time-to-first analyses.
  • This increased event count led to more precise treatment effect estimates.
  • Statistical power was enhanced by incorporating recurrent events.

Conclusions:

  • Recurrent event data analysis is recommended for progressive MS trials.
  • This approach improves treatment effect estimation and statistical power.
  • It provides a better understanding of long-term disability progression in MS.