Marcus W Koch1, Jop Mostert2, Bernard Uitdehaag3, Gary Cutter4. 1. Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada/Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada. 2. Department of Neurology, Rijnstate Hospital, Arnhem, The Netherlands. 3. Department of Neurology, MS Center Amsterdam, Amsterdam University Medical Center, Amsterdam, The Netherlands. 4. Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, USA.
Abstract
BACKGROUND: Still too little is known about the natural history of clinical outcome measures beyond the Expanded Disability Status Scale (EDSS), such as the timed 25-foot walk (T25FW) and nine-hole peg test (9HPT) in secondary progressive multiple sclerosis (SPMS). OBJECTIVE: To describe progression on the EDSS, T25FW, 9HPT, and their combinations. To investigate the association of the baseline characteristics age, sex, EDSS, T25FW, gadolinium-enhancing lesions, and relapse activity with EDSS and T25FW progression. METHODS: Using original trial data from the placebo arms of the IMPACT and ASCEND randomized controlled trials, we describe disability progression (with and without 3- or 6-month confirmation). We investigated the association of selected baseline characteristics with EDSS and T25FW progression over 2 years using binary logistic regression. RESULTS: T25FW was the single outcome measure with the largest proportion of patients progressing, followed by EDSS and 9HPT. EDSS and T25FW at baseline were associated with EDSS and T25FW progression in both data sets. Age and relapse activity were only mild and inconsistent predictors, while sex and gadolinium enhancement at baseline did not predict disability progression in either data set. CONCLUSION: Our analyses inform the selection of primary outcome measures as well as inclusion criteria for clinical trials in SPMS.
RCT Entities:
BACKGROUND: Still too little is known about the natural history of clinical outcome measures beyond the Expanded Disability Status Scale (EDSS), such as the timed 25-foot walk (T25FW) and nine-hole peg test (9HPT) in secondary progressive multiple sclerosis (SPMS). OBJECTIVE: To describe progression on the EDSS, T25FW, 9HPT, and their combinations. To investigate the association of the baseline characteristics age, sex, EDSS, T25FW, gadolinium-enhancing lesions, and relapse activity with EDSS and T25FW progression. METHODS: Using original trial data from the placebo arms of the IMPACT and ASCEND randomized controlled trials, we describe disability progression (with and without 3- or 6-month confirmation). We investigated the association of selected baseline characteristics with EDSS and T25FW progression over 2 years using binary logistic regression. RESULTS: T25FW was the single outcome measure with the largest proportion of patients progressing, followed by EDSS and 9HPT. EDSS and T25FW at baseline were associated with EDSS and T25FW progression in both data sets. Age and relapse activity were only mild and inconsistent predictors, while sex and gadolinium enhancement at baseline did not predict disability progression in either data set. CONCLUSION: Our analyses inform the selection of primary outcome measures as well as inclusion criteria for clinical trials in SPMS.
Authors: Marcus W Koch; Jop P Mostert; Jerry S Wolinsky; Fred D Lublin; Bernard Uitdehaag; Gary R Cutter Journal: Neurology Date: 2021-08-25 Impact factor: 11.800
Authors: Marcus W Koch; Jop Mostert; Pavle Repovic; James D Bowen; Eva Strijbis; Bernard Uitdehaag; Gary Cutter Journal: Mult Scler Date: 2021-12-30 Impact factor: 5.855
Authors: Eva Mm Strijbis; Pavle Repovic; Jop Mostert; James D Bowen; Bernard Mj Uitdehaag; Gary Cutter; Marcus W Koch Journal: Mult Scler Date: 2022-09 Impact factor: 5.855
Authors: Anissa Kalinowski; Gary Cutter; Nina Bozinov; Jessica A Hinman; Michael Hittle; Robert Motl; Michelle Odden; Lorene M Nelson Journal: Mult Scler Date: 2021-06-08 Impact factor: 5.855
Authors: Marcus W Koch; Jop Mostert; Pavle Repovic; James D Bowen; Eva Strijbis; Bernard Uitdehaag; Gary Cutter Journal: Mult Scler Date: 2021-07-26 Impact factor: 6.312