Functional clinical outcomes in multiple sclerosis: Current status and future prospects

Abstract

For decades, the Expanded Disability Status Scale (EDSS) has been the principal measure of disability in clinical trials in patients with multiple sclerosis (MS) and in clinical practice. However, this test is dominated by effects on ambulation. Composite endpoints may provide a more sensitive measure of MS-related disability through the measurement of additional neurological functions. The MS Functional Composite (MSFC) includes a walking test (25-ft walk) plus tests of upper extremity dexterity (9-hole peg test) and cognitive function (Paced Auditory serial Addition test [PASAT]). Replacing PASAT with the Symbol Digit Modality test, a more sensitive test preferred by patients, may improve the clinical utility of the MSFC. In addition, disease-specific measures of QoL may be used alongside the MSFC (which does not include measurement of QoL). Clinical data suggest that disease-modifying therapies may delay or prevent relapse, and better composite measures will be valuable in the assessment of disease activity-free status in people with MS.

Keywords: Clinical outcome measures; Clinical trials; Disease-modifying therapies; Multiple sclerosis.