Greater sensitivity to multiple sclerosis disability worsening and progression events using a roving versus a fixed reference value in a prospective cohort study
AuthorKappos, L; Butzkueven, H; Wiendl, H; Spelman, T; Pellegrini, F; Chen, Y; Dong, Q; Koendgen, H; Belachew, S; Trojano, M
Source TitleMultiple Sclerosis Journal
PublisherSAGE PUBLICATIONS LTD
Surgery (St Vincent's)
Document TypeJournal Article
CitationsKappos, L., Butzkueven, H., Wiendl, H., Spelman, T., Pellegrini, F., Chen, Y., Dong, Q., Koendgen, H., Belachew, S. & Trojano, M. (2018). Greater sensitivity to multiple sclerosis disability worsening and progression events using a roving versus a fixed reference value in a prospective cohort study. MULTIPLE SCLEROSIS JOURNAL, 24 (7), pp.963-973. https://doi.org/10.1177/1352458517709619.
Access StatusOpen Access
BACKGROUND: Confirmed Expanded Disability Status Scale (EDSS) progression occurring after a fixed-study entry baseline is a common measure of disability increase in relapsing-remitting multiple sclerosis (RRMS) studies but may not detect all disability progression events, especially those unrelated to overt relapses. OBJECTIVE: To evaluate possible measures of disability progression unrelated to relapse using EDSS data over ≈5.5 years from the Tysabri® Observational Program (TOP). METHODS: TOP is an ongoing, prospective, open-label study in RRMS patients receiving intravenous 300 mg natalizumab every 4 weeks. Measures of increasing disability were assessed using as a reference either study baseline score or a "roving" system that resets the reference score after ⩾24- or ⩾48-week confirmation of a new score. RESULTS: This analysis included 5562 patients. Approximately 70% more EDSS progression events unrelated to relapse and 50% more EDSS worsening events overall were detected with a roving reference score (cumulative probability: 17.6% and 29.7%, respectively) than with a fixed reference baseline score (cumulative probability: 10.1% and 20.3%, respectively). CONCLUSION: In this long-term observational RRMS dataset, a roving EDSS reference value was more efficient than a study baseline EDSS reference in detecting progression/worsening events unrelated to relapses and thus the transition to secondary progressive disease.
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