Overall Disability Response Score: An integrated endpoint to assess disability improvement and worsening over time in patients with multiple sclerosis.

ABSTRACT:

Background

Overall Disability Response Score (ODRS) is a composite endpoint including Expanded Disability Status Scale, Timed 25-foot Walk, and 9-Hole Peg Test, designed to quantify both disability improvement and worsening in multiple sclerosis (MS).

Objective

To assess the sensitivity and clinical meaningfulness of ODRS using natalizumab Phase 3 data sets (AFFIRM in relapsing-remitting MS and ASCEND in secondary progressive MS).

Methods

Differences in ODRS over 96 weeks, ODRS at Week 96, and slope of ODRS change per year between natalizumab and placebo groups were analyzed. Correlation between ODRS and changes in patient-reported outcomes was also analyzed.

Results

The difference (95% confidence interval (CI)) in the ODRS over 96 weeks between natalizumab and

SUBMITTER: Chang I 

PROVIDER: S-EPMC9732786 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature