Disability Outcome Measures in Phase III Clinical Trials in Multiple Sclerosis

Figures

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  Fig. 1. Disability outcomes measures used in phase III relapsing multiple sclerosis or RRMS trials (n = 16). Includes unpublished trials and trials published from 2012 onwards (with the exception of the DEFINE and CONFIRM trials, which are included in the review by Lavery et al. [20]). EDSS Expanded Disability Status Scale, FDA freedom from disease activity, MSFC Multiple Sclerosis Functional Composite, MSIS Multiple Sclerosis Impact Scale, NEDA no evidence of disease activity, SF-36 Medical Outcomes Study Short-Form (36-item) Health Survey, RRMS relapsing-remitting multiple sclerosis

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  Fig. 2. Disability outcome measures used over time in phase III relapsing multiple sclerosis or RRMS trials (n = 16). Includes unpublished trials and trials published from 2012 onwards (with the exception of the DEFINE and CONFIRM trials, which are included in the review by Lavery et al. [20]); ongoing trials were sourced from ClinicalTrials.gov; dates refer to study initiation. EDSS Expanded Disability Status Scale, FDA freedom from disease activity, MSFC Multiple Sclerosis Functional Composite, MSIS Multiple Sclerosis Impact Scale, NEDA no evidence of disease activity, SF-36 Medical Outcomes Study Short-Form (36-item) Health Survey, RRMS relapsing-remitting multiple sclerosis. There was one trial published in 2014, which did not include any disability outcome measures

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  Fig. 3. Disability outcome measures used in phase III progressive MS trials (n = 18): a EDSS-related measures; b other outcome measures. Includes unpublished trials and trials published from 1997 onwards; note that in some trials, endpoints relating to the same measure were included as both primary and secondary endpoints (e.g. time to 3-month worsening of EDSS and the proportion of patients with 3-month worsening of EDSS). AUC area under the curve, CGI-I Clinical Global Impression of Improvement, EDSS Expanded Disability Status Scale, MSFC Multiple Sclerosis Functional Composite, MS multiple sclerosis, PGI-I Patient Global Impression of Improvement, RFSS Regional Functional System Score, SF-36 Medical Outcomes Study Short-Form (36-item) Health Survey, SNRS Scripps Neurologic Rating Scale

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  Fig. 4. Disability outcome measures used over time in phase III progressive MS trials published since 2007 (n = 18): a EDSS-related measures; b other outcome measures. Published trials only (trials could not be assessed according to start date, as this was not available for all published trials). EDSS Expanded Disability Status Scale, MS multiple sclerosis, MSFC Multiple Sclerosis Functional Composite, RFSS Regional Functional Scoring Scale, SF–36 Medical Outcomes Study Short-Form (36-item) Health Survey, SNRS Scripps Neurologic Rating Scale