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The Multiple Sclerosis Performance Test MSPT: An iPad-Based Disability Assessment Tool
Published on: June 30, 2014
58.9K
The EDSS-Plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis
Diego Cadavid1, Jeffrey A Cohen2, Mark S Freedman3
1Biogen, Cambridge, MA, USA.
Multiple Sclerosis (Houndmills, Basingstoke, England)
|March 23, 2016
Summary
A new composite endpoint, EDSS-Plus, combining the Expanded Disability Status Scale (EDSS) with the timed 25-foot walk (T25FW) and 9-Hole Peg Test (9HPT), better detects disability progression in secondary progressive multiple sclerosis (SPMS). This approach identifies more SPMS patients with worsening function than EDSS alone.
Area of Science:
- Neurology
- Clinical Trials
- Biostatistics
Background:
- The Expanded Disability Status Scale (EDSS) is widely used but has limited ability to detect meaningful disability progression in secondary progressive multiple sclerosis (SPMS).
- This limitation stems partly from its inability to adequately measure short-distance ambulation and upper-extremity function.
- Improved assessment tools are needed for SPMS patient disability progression.
Purpose of the Study:
- To propose and validate a novel composite endpoint, EDSS-Plus, for assessing disability progression in SPMS.
- EDSS-Plus integrates the EDSS with the timed 25-foot walk (T25FW) and the 9-Hole Peg Test (9HPT).
- To evaluate the performance of EDSS-Plus compared to individual components in detecting SPMS progression.
Main Methods:
- Analysis of data from the placebo arm of the International Multiple Sclerosis Secondary Progressive Avonex Clinical Trial (IMPACT) (n=215).
- Defined EDSS-Plus as progression in EDSS, T25FW, or 9HPT (dominant/non-dominant hand) confirmed at least 24 weeks apart.
- A minimum 20% change threshold was applied to T25FW and 9HPT for progression detection.
Main Results:
- Over 2 years, SPMS progressors showed significant worsening in T25FW (103.4%) and 9HPT (69.0% dominant, 59.2% non-dominant hands).
- EDSS-Plus identified 59.5% of patients with 24-week confirmed disability progression.
- This is substantially higher than progression rates detected by EDSS alone (24.7%), T25FW alone (41.9%), or 9HPT alone (34.4%).
Conclusions:
- A 24-week confirmed minimum worsening of 20% in T25FW and 9HPT effectively distinguishes SPMS progressors from non-progressors.
- The proposed EDSS-Plus composite endpoint demonstrates improved sensitivity in identifying disability progression in SPMS patients.
- EDSS-Plus may offer a more comprehensive and clinically relevant measure for SPMS progression assessment in clinical trials.
