Can We Track Multiple Sclerosis with a Composite Disability Worsening Endpoint?

A large, pooled analysis supports the use of composite confirmed disability worsening as a more sensitive and clinically meaningful endpoint than the Expanded Disability Status Scale alone in clinical trials.

The Expanded Disability Status Scale (EDSS), the standard disability measure in multiple sclerosis (MS) trials, lacks sensitivity and fails to capture important functional changes, limiting its utility in modern clinical trials. This post hoc analysis used individual patient data from six manufacturer-sponsored phase 3 trials (n=4979) and aggregate data from nine published MS trials to evaluate the predictive value of two performance-based tests-timed 25-foot walk test (T25FWT) and nine-hole peg test (9HPT) and their integration with EDSS to create a composite endpoint of confirmed disability worsening or progression (cCDW/cCDP).

The main findings were:

T25FWT and 9HPT worsening events were significantly associated with subsequent EDSS worsen…

Reviewing Author

Robert T. Naismith, MD

Disclosures

Consultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics

Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense

Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)

Robert T. Naismith, MD

Disclosures

Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense

Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)

Can We Track Multiple Sclerosis with a Composite Disability Worsening Endpoint?

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Reviewing Author