ECTRIMS eLearning

Multiple Sclerosis Treatment Decisions: EDSS Independent Disease Impact/Reserve and the Use of Additional Economically Impactful Milestones that Matter
ECTRIMS Learn. Gudesblatt M. 10/25/17; 199442; EP1422
Mark Gudesblatt
Mark Gudesblatt
Contributions
Abstract

Abstract: EP1422

Type: ePoster

Abstract Category: Clinical aspects of MS - 9 Economic burden

Objective: Explore objective computerized cognitive outcome measures to identify MS disability trajectory as it relates to impact not always apparent by relapse, EDSS or MRI. Background/rationale: MS, characterized by relapses/progression, is traditionally measured by EDSS/MRI change and relapse rate reduction. EDSS change is primarily driven by walking impairment but this does not account for cognitive impact/reserve nor accumulation of cognitive impairment. Cognitive impairment impacts abilities not addressed by traditional metrics (e.g. employment, ability to drive, and fall risk for simple or complex daily activities. There are multiple available disease modifying therapies (DMT) of varied routes/potencies making individual treatment choice/change problematic. A patient centric objective analysis of likely trajectory of economically important milestones relating to predictive loss of such abilities an alternative approach to guiding treatment choice/change.  This objective/quantitative, EDSS independent, approach of likely disability trajectory might improve decision making regarding DMT choice/change and offer a path to compare outcome measures across clinical trials.
Methods: Retrospective cross-sectional review of a prospective digital MS registry obtained in the course of routine care utilizing standardized computerized cognitive testing to evaluate the relationship of cognitive impairment (number of cognitive domains impaired (CDI) >1 standard deviation from age/education normal) on patient reported outcome disability (unemployment, loss of driving, increased fall risk) in people with EDSS< 7.
Results: Increasing accumulated number of CDI is associated with progressive loss of: employment (N=543, CDI-0=63%, CDI-1=53%, CDI-2=45%, CDI-3=23%) driving (N=126, CDI-0=86, CDI-1=69%, CDI-2=61%, CDI-3=20%) and reduced safety with increased fear of falling for simple daily activities [(FOF-SDA), N=174, CDI-0=74%, CDI-1=69%, CDI-2=35%, CDI-3=29%) and increased fall of falling for complex daily activities [(FOF-CDA), N=174, CDI-0=71%, CDI-1=65%, CDI-2=33%, CDI-3=32%).
Conclusions: Tracking disease impact by economically important milestones trajectory beyond EDSS/MRI or relapse can be obtained by use of cognitive testing to provide patient centric information predicting loss likelihood of important milestones not completely dependent upon EDSS which might provide a pathway of actionable change to monitor therapy choice or disease progression. 
Disclosure: This study was not supported by outside funding
Gudesblatt M: Research support from Biogen, Teva, Sanofi-Genzyme, Novartis and EMD Serono; and speaker fees/consultant for: Biogen, Novartis, Teva, Sanofi-Genzyme, Amgen, Saol Therapeutics, Medtronic, Accorda, TG Therapeutics, EMD Serono
Wilken J: grants and personal fees from Biogen, Sanofi Genzyme and George Washington University.
Wissemann K: nothing to disclose
Golan D: nothing to disclose
Sullivan C: nothing to disclose
Fafard L: nothing to disclose
Bumstead B: Speaker fees from Biogen, Genentech, Sanofi-Genzyme, and Teva. Buhse M: Speaker fees from Sanofi-Genzyme, and Teva.
Zarif M: Speaker fees from Acorda, Biogen, Sanofi-Genzyme, and Teva
Doniger G: employee of NeuroTrax

Abstract: EP1422

Type: ePoster

Abstract Category: Clinical aspects of MS - 9 Economic burden

Objective: Explore objective computerized cognitive outcome measures to identify MS disability trajectory as it relates to impact not always apparent by relapse, EDSS or MRI. Background/rationale: MS, characterized by relapses/progression, is traditionally measured by EDSS/MRI change and relapse rate reduction. EDSS change is primarily driven by walking impairment but this does not account for cognitive impact/reserve nor accumulation of cognitive impairment. Cognitive impairment impacts abilities not addressed by traditional metrics (e.g. employment, ability to drive, and fall risk for simple or complex daily activities. There are multiple available disease modifying therapies (DMT) of varied routes/potencies making individual treatment choice/change problematic. A patient centric objective analysis of likely trajectory of economically important milestones relating to predictive loss of such abilities an alternative approach to guiding treatment choice/change.  This objective/quantitative, EDSS independent, approach of likely disability trajectory might improve decision making regarding DMT choice/change and offer a path to compare outcome measures across clinical trials.
Methods: Retrospective cross-sectional review of a prospective digital MS registry obtained in the course of routine care utilizing standardized computerized cognitive testing to evaluate the relationship of cognitive impairment (number of cognitive domains impaired (CDI) >1 standard deviation from age/education normal) on patient reported outcome disability (unemployment, loss of driving, increased fall risk) in people with EDSS< 7.
Results: Increasing accumulated number of CDI is associated with progressive loss of: employment (N=543, CDI-0=63%, CDI-1=53%, CDI-2=45%, CDI-3=23%) driving (N=126, CDI-0=86, CDI-1=69%, CDI-2=61%, CDI-3=20%) and reduced safety with increased fear of falling for simple daily activities [(FOF-SDA), N=174, CDI-0=74%, CDI-1=69%, CDI-2=35%, CDI-3=29%) and increased fall of falling for complex daily activities [(FOF-CDA), N=174, CDI-0=71%, CDI-1=65%, CDI-2=33%, CDI-3=32%).
Conclusions: Tracking disease impact by economically important milestones trajectory beyond EDSS/MRI or relapse can be obtained by use of cognitive testing to provide patient centric information predicting loss likelihood of important milestones not completely dependent upon EDSS which might provide a pathway of actionable change to monitor therapy choice or disease progression. 
Disclosure: This study was not supported by outside funding
Gudesblatt M: Research support from Biogen, Teva, Sanofi-Genzyme, Novartis and EMD Serono; and speaker fees/consultant for: Biogen, Novartis, Teva, Sanofi-Genzyme, Amgen, Saol Therapeutics, Medtronic, Accorda, TG Therapeutics, EMD Serono
Wilken J: grants and personal fees from Biogen, Sanofi Genzyme and George Washington University.
Wissemann K: nothing to disclose
Golan D: nothing to disclose
Sullivan C: nothing to disclose
Fafard L: nothing to disclose
Bumstead B: Speaker fees from Biogen, Genentech, Sanofi-Genzyme, and Teva. Buhse M: Speaker fees from Sanofi-Genzyme, and Teva.
Zarif M: Speaker fees from Acorda, Biogen, Sanofi-Genzyme, and Teva
Doniger G: employee of NeuroTrax

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