Benefits of Repeated Confirmed Disability Progressions Analyses in MS Clinical Trials: A Case Study Using the OPERA and ORATORIO Trials and Their Open-Label Extensions

Time-to-first event analysis, the current gold-standard endpoint to assess disability accumulation in MS clinical trials, excludes subsequent on-trial repeated progression events, thereby potentially missing the overall effect of a DMT. Including repeated progression events in trial analysis may permit a more comprehensive assessment of DMT effects on disability progression. Results are reported for the rate of repeated 48-week confirmed disability progressions on EDSS (and other measures of progression and disease activity) during OPERA and ORATORIO and their ongoing open-label extensions.

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