The impact of relapse definition and measures of durability on MS clinical trial outcomes.
Sammita SatyanarayanGary R CutterStephen KriegerStacey CofieldJerry S WolinskyFred LublinPublished in: Multiple sclerosis (Houndmills, Basingstoke, England) (2023)
The stringency of relapse definition impacted absolute ARR and composite endpoints in RRMS. Despite the most generous relapse definition, 43% of patients meeting PIRA on trial did not have durable worsening suggesting that relapse definition and durability should be considered to avoid overestimating progression in RRMS trials.