Keywords: neuro-physical composite endpoint, disability progression, disability improvement, overall response score
Multiple sclerosis (MS) is a chronic autoimmune and neurodegenerative disorder of the central nervous system (CNS) that is characterized by inflammation, demyelination, axonal transection, and neuronal loss. In spite of therapeutic advance, many patients with MS continue to experience disability progression, with or independent of relapses, with a concordant loss of physical and cognitive function. The Expanded Disability Status Scale (EDSS) is widely used in clinical trials as a method of quantifying disability status in MS. Other widely used measures of disability in MS include the timed 25-foot walk (T25FW) and the 9-hole peg test (9HPT). Recent research has suggested that a combined disability measure that incorporates scoring from multiple instruments, for example, using T25FW, 9HPT, and EDSS, may be more sensitive to detect associated disability progression or disability improvement events than with any single instrument alone. In this talk, multiple ways of the composite endpoint, which is derived from the EDSS, T25FW and 9HPT assessments, will be discussed. In addition, the distribution and time course of the events and the correlation between endpoints will also be assessed. Examples will be given using the placebo data from the MSOAC database.