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Changing EDSS Progression in Placebo Cohorts in Relapsing MS: A Systematic Review and Meta-Regression

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  • Christian Röver
  • Richard Nicholas
  • Sebastian Straube
  • Tim Friede

Abstract

Background: Recent systematic reviews of randomised controlled trials (RCTs) in relapsing multiple sclerosis (RMS) revealed a decrease in placebo annualized relapse rates (ARR) over the past two decades. Furthermore, regression to the mean effects were observed in ARR and MRI lesion counts. It is unclear whether disease progression measured by the expanded disability status scale (EDSS) exhibits similar features. Methods: A systematic review of RCTs in RMS was conducted extracting data on EDSS and baseline characteristics. The logarithmic odds of disease progression were modelled to investigate time trends. Random-effects models were used to account for between-study variability; all investigated models included trial duration as a predictor to correct for unequal study durations. Meta-regressions were conducted to assess the prognostic value of a number of study-level baseline variables. Results: The systematic literature search identified 39 studies, including a total of 19,714 patients. The proportion of patients in placebo controls experiencing a disease progression decreased over the years (p

Suggested Citation

  • Christian Röver & Richard Nicholas & Sebastian Straube & Tim Friede, 2015. "Changing EDSS Progression in Placebo Cohorts in Relapsing MS: A Systematic Review and Meta-Regression," PLOS ONE, Public Library of Science, vol. 10(9), pages 1-10, September.
    • Handle: RePEc:plo:pone00:0137052
    DOI: 10.1371/journal.pone.0137052
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    References listed on IDEAS

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    1. Jan-Patrick Stellmann & Klarissa Hanja Stürner & Kim Lea Young & Susanne Siemonsen & Tim Friede & Christoph Heesen, 2015. "Regression to the Mean and Predictors of MRI Disease Activity in RRMS Placebo Cohorts - Is There a Place for Baseline-to-Treatment Studies in MS?," PLOS ONE, Public Library of Science, vol. 10(2), pages 1-14, February.
    2. Viechtbauer, Wolfgang, 2010. "Conducting Meta-Analyses in R with the metafor Package," Journal of Statistical Software, Foundation for Open Access Statistics, vol. 36(i03).
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    1. Georgios Tsivgoulis & Aristeidis H Katsanos & Dimitris Mavridis & Nikolaos Grigoriadis & Efthymios Dardiotis & Ioannis Heliopoulos & Panagiotis Papathanasopoulos & Theodoros Karapanayiotides & Constan, 2016. "The Efficacy of Natalizumab versus Fingolimod for Patients with Relapsing-Remitting Multiple Sclerosis: A Systematic Review, Indirect Evidence from Randomized Placebo-Controlled Trials and Meta-Analys," PLOS ONE, Public Library of Science, vol. 11(9), pages 1-14, September.

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