Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis.

ABSTRACT:

Background

Disease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI).

Objective and methods

Post hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5-1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo.

Results

At 8 years' follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%-43.1%) of assessed participants in the IFNβ-1a-fingolimod switch gro

SUBMITTER: Cree BA 

PROVIDER: S-EPMC8597182 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature