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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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A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
10:46

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Published on: December 9, 2015

Assessing changes in relapse rates in multiple sclerosis.

Seidu Inusah1, Maria P Sormani, Stacey S Cofield

  • 1University of Alabama at Birmingham, Department of Biostatistics, Birmingham, Alabama 35294-0022, USA.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|September 3, 2010
PubMed
Summary
This summary is machine-generated.

Annualized relapse rates (ARRs) in Multiple Sclerosis (MS) clinical trials have declined over time. This trend is primarily driven by the publication year, suggesting patient selection and relapse management influence observed ARRs.

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Area of Science:

  • Neurology
  • Clinical Trials
  • Epidemiology

Background:

  • Multiple Sclerosis (MS) annualized relapse rates (ARRs) in clinical trials may be influenced by evolving diagnostic criteria, disease etiology, and study selection biases.
  • A potential declining trend in ARRs over time warrants investigation to understand its underlying causes.

Purpose of the Study:

  • To examine the trend in ARRs for relapsing-remitting MS (RRMS) patients in clinical trials from 1960 to 2008.
  • To identify factors contributing to any observed changes in ARRs over this period.

Main Methods:

  • A comprehensive literature search was conducted across PubMed, Web of Science, and Cochrane Library for randomized trials published between 1960 and 2008.
  • Data from 32 placebo-controlled RRMS studies were analyzed, focusing on relapse definitions and patient characteristics.
  • Statistical analysis was performed to assess the association between publication year, patient age, symptom duration, and ARR.

Main Results:

  • The mean ARR in treatment arms was 0.68, and in placebo groups was 1.002.
  • Publication year showed a significant negative association with ARR (p = 0.0001), indicating a decline over time.
  • Age and duration of symptoms were also negatively associated with ARR, but publication year remained significant after controlling for covariates.

Conclusions:

  • ARRs in RRMS clinical trials have demonstrably fallen over time, with the year of publication being the most significant factor.
  • While relapse definitions and entrance criteria play a role, the temporal trend suggests patient selection by clinicians and interventions that reduce relapse frequency are key drivers.
  • The impact of these factors on falling ARRs and informative censoring in drop-outs requires careful consideration in trial interpretation.