The impact of relapse definition and measures of durability on MS clinical trial outcomes.

ABSTRACT:

Background

Definitions of trial measures are consequential to accurately capturing outcomes and cross-trial comparability, particularly for derivative measures.

Objective

Using CombiRx, examine the impact of relapse definition on endpoints and evaluate the durability of progression measures in Relapsing Remitting Multiple Sclerosis (RRMS).

Methods

CombiRx relapse types were distinguished by the presence or timing of Expanded Disability Status Scale (EDSS) increase. Using the broadest definition of relapse, progression endpoints were assessed in patients without relapses on trial. Durability compared EDSS at study end and time of worsening.

Results

Broadening relapse definition to the most inclusive definition increased annualized relapse rate (ARR) threefold in

SUBMITTER: Satyanarayan S 

PROVIDER: S-EPMC10471316 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature