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Background: Recent systematic reviews of randomised controlled trials (RCTs)in relapsing multiple sclerosis (RMS) revealed a decrease in placebo annualizedrelapse rates (ARR) over the past two decades. Furthermore, regression to themean effects were observed in ARR and MRI lesion counts. It is unclear whetherdisease progression measured by the expanded disability status scale (EDSS)exhibits similar features.  Methods: A systematic review of RCTs in RMS was conducted extracting data onEDSS and baseline characteristics. The logarithmic odds of disease progressionwere modelled to investigate time trends. Random-effects models were used toaccount for between-study variability; all investigated models included trialduration as a predictor to correct for unequal study durations.Meta-regressions were conducted to assess the prognostic value of a number ofbaseline variables.  Results: The systematic literature search identified 39 studies, including atotal of 19,714 patients. The proportion of patients in placebo controlsexperiencing a disease progression decreased over the years (p<0.001). Metaregression identified associated covariates including the size of the study andits duration that in part explained the time trend. Progression probabilitiestended to be lower in the second year compared to the first year with areduction of 24% in progression probability from year 1 to year 2 (p=0.014).  Conclusion: EDSS disease progression exhibits similar behaviour over time asthe ARR and point to changes in trial characteristics over the years,questioning comparisons between historical and recent trials.

Changing EDSS progression in placebo cohorts in relapsing MS: A systematic review and meta-regression