Composite end points to assess delay of disability progression by MS treatments
Diagnosis, monitoring and biomarkers:
It has been shown that the Expanded Disability Status Scale (EDSS) has low sensitivity for detecting sustained disability progression (SDP) in MS trials. Based on this, this study looked at composite disability end points as alternatives to EDSS alone to overcome the operational and conceptual limitations of the EDSS In detecting MS disability progression.
Ninety-six week data from the Olympus trial (rituximab in patients with primary progressive MS), was used and SDP was analysed using composite disability end points. Composite A included SDP in EDSS, timed 25-foot walk test (T25FWT), or nine-hole peg test (9HPT); composite B included SDP in T25FWT or 9HPT; composite C included SDP in EDSS and (T25FWT or 9HPT) and composite D included any two (EDSS, T25FWT, and 9HPT).
The results showed that composite A showed similar treatment effect estimate versus EDSS alone with much higher SDP rates. Composite B, C and D all showed greater treatment effect estimate with different or similar SDP rates versus EDSS alone.
This shows that composite end points may be superior to EDSS alone in monitoring disability progression. This may reduce sample sizes in MS trials and should be considered in MS clinical trials in the future.
Zhang J, Waubant E
: Mult Scler. 2014 Mar 27. [Epub ahead of print]
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