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Background: Recent studies have shown a decrease in annualised relapse rates(ARRs) in placebo groups of randomised controlled trials (RCTs) in relapsingmultiple sclerosis (RMS).  Methods: We conducted a systematic literature search of RCTs in RMS. Data oneligibility criteria and baseline characteristics were extracted and tested forsignificant trends over time. A meta-regression was conducted to estimate theircontribution to the decrease of trial ARRs over time.  Results: We identified 56 studies. Patient age at baseline (p < 0.001), meanduration of multiple sclerosis (MS) at baseline (p = 0.048), size of treatmentgroups (p = 0.003), Oxford Quality Scale scores (p = 0.021), and the number ofeligibility criteria (p<0.001) increased significantly, whereas pre-trial ARR(p = 0.001), the time span over which pre-trial ARR was calculated (p < 0.001),and the duration of placebo-controlled follow-up (p = 0.006) decreasedsignificantly over time. In meta-regression of trial placebo ARR, the temporaltrend was found to be insignificant, with major factors explaining thevariation: pre-trial ARR, the number of years used to calculate pre-trial ARRand study duration. Conclusion: The observed decline in trial ARRs may resultfrom decreasing pre-trial ARRs and a shorter time period over which pre-trialARRs were calculated. Increasing patient age and duration of illness may alsocontribute.

multiple sclerosis

Explaining temporal trends in annualized relapse rates in placebo groups  of randomized controlled trials in relapsing multiple sclerosis: systematic  review and meta-regression