Contributions
Abstract: EP1334
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Natural course
Introduction: Wearable biosensors allow for continuous physiological monitoring of patients, which may improve treatment and management of chronic illnesses such as MS.
Objective: To estimate longitudinal change in the daily averages of 12 free-living biosensor measurements collected in 23 multiple sclerosis (MS) patients and to compare the measurements in different severity groups.
Methods: 25 MS patients were enrolled in a biosensor study at Brigham and Women's Hospital. Patients wore digital biosensors during three in-clinic visits and eight weeks continuously at home between the second and third visit. 23 patients (96% females, baseline mean age 46.4±7.7) completed the at home period. Patients wore three biosensors (wrist, ankle and sternum) and 12 average daily free-living measurements were derived. Patients were stratified into three groups based on baseline Expanded Disability Status Scale (EDSS) score (0.0-2.5 = 10 subjects (~44%), 3.0-4.5 = 6 subjects (~26%), and ≥5.0 = 7 subjects (~30%)). Linear mixed effects regression models assessed longitudinal change in daily free-living measurements with fixed effects for time, baseline severity groups, and time by group interaction as well as a random intercept and slope.
Results: Four free-living features including stance time (p=0.0036), swing time (p=0.0083), max turn velocity ankle (p=0.0278), and turn velocity ankle SD (p=0.0078) showed significant difference in the three severity groups. There was no significant change in the measures over time or difference in the longitudinal change between groups. During this same period, there were no clinically significant changes in disease status observed within any individuals as measured by EDSS.
Conclusions: This study demonstrated that a novel digital biosensor signature correlated with baseline physician severity ratings using EDSS. The biosensor data was acquired without patient effort in the free-living environment, suggesting that home biosensor tracking may substitute for, or supplement in-office physician assessment for monitoring MS.
Disclosure: Cindy Gonzalez received research support from Verily Life Sciences. Dr. Healy has received research support from Merck Serono, Genzyme, Novartis, and Verily Life Sciences. Dr. Glanz received research support from Verily Life Sciences. Taylor J. Saraceno received research support from Verily Life Sciences. Dr. Sattarnezhad received research support from Verily Life Sciences and Serono. Dr. Diaz-Cruz received research support from Verily Life Sciences and Serono. Mariann Polgar-Turcsanyi has nothing to disclose. Dr. Tummala has nothing to disclose. Dr. Bakshi has received consulting fees from Bayer, EMD Serono, Genentech, Guerbet, Sanofi-Genzyme, and Shire and research support from EMD Serono and Sanofi-Genzyme. David Ben-Shimol is an employee and equity holders at Verily Life Sciences. Nikhil Bikhchandani is an employee and equity holders at Verily Life Sciences.Joshua Burkart is an employee and equity holders at Verily Life Sciences. Michael Cusack is an employee and equity holders at Verily Life Sciences. Emre Demiralp is an employee and equity holders at Verily Life Sciences. Alaa Kharbouch is an employee and equity holders at Verily Life Sciences. Amy A. Lee is an employee and equity holders at Verily Life Sciences. Manway Liu is an employee and equity holders at Verily Life Sciences. Swaminathan Mahadevan is an employee and equity holders at Verily Life Sciences. Linda C. Norton is an employee and equity holders at Verily Life Sciences. Tushar A. Parlikar is an employee and equity holders at Verily Life Sciences. Anupam Pathak is an employee and equity holders at Verily Life Sciences. Ali Shoeb is an employee and equity holders at Verily Life Sciences. Erin Soderberg is an employee and equity holders at Verily Life Sciences. Philip Stephens is an employee and equity holders at Verily Life Sciences. Aaron H. Stoertz is an employee and equity holders at Verily Life Sciences. Florence Thng is an employee and equity holders at Verily Life Sciences. Kashyap Tumkur is an employee and equity holders at Verily Life Sciences. Hongsheng Wang is an employee and equity holders at Verily Life Sciences. Jane Rhodes was an employee at Biogen during the study period. Dr. Rudick is an employee of Biogen and holds stock and/or stock options in the company. Richard M. Ransohoff was an employee at Biogen during the study period. Glenn A. Phillips was an employee at Biogen during the study period.
Effie Bruzik is an employee at Biogen. William J. Marks is an employee and equity holders at Verily Life Sciences. Dr. Weiner has research support from NIH, NMSS, Verily Life Sciences, EMD Serono, Biogen, Teva Pharmaceuticals, Sanofi, and Novartis. Research support and consulting fees from Genentech, Inc., Tilos Therapeutics, Tiziana Life Sciences, and IM Therapeutics. Personal and consulting fees from vTv Therapeutics and MedDay Pharmaceuticals. Thomas M. Snyder is an employee and equity holders at Verily Life Sciences. Dr. Chitnis has served on the advisory boards for clinical trials sponsored by Novartis and Sanofi-Genzyme, and has received consulting/advisory fees from Bayer, Biogen, Celgene, Genentech-Roche, Novartis and Sanofi-Genzyme. She has received research grant support from Biogen, Octave, Serono and Verily.
Abstract: EP1334
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Natural course
Introduction: Wearable biosensors allow for continuous physiological monitoring of patients, which may improve treatment and management of chronic illnesses such as MS.
Objective: To estimate longitudinal change in the daily averages of 12 free-living biosensor measurements collected in 23 multiple sclerosis (MS) patients and to compare the measurements in different severity groups.
Methods: 25 MS patients were enrolled in a biosensor study at Brigham and Women's Hospital. Patients wore digital biosensors during three in-clinic visits and eight weeks continuously at home between the second and third visit. 23 patients (96% females, baseline mean age 46.4±7.7) completed the at home period. Patients wore three biosensors (wrist, ankle and sternum) and 12 average daily free-living measurements were derived. Patients were stratified into three groups based on baseline Expanded Disability Status Scale (EDSS) score (0.0-2.5 = 10 subjects (~44%), 3.0-4.5 = 6 subjects (~26%), and ≥5.0 = 7 subjects (~30%)). Linear mixed effects regression models assessed longitudinal change in daily free-living measurements with fixed effects for time, baseline severity groups, and time by group interaction as well as a random intercept and slope.
Results: Four free-living features including stance time (p=0.0036), swing time (p=0.0083), max turn velocity ankle (p=0.0278), and turn velocity ankle SD (p=0.0078) showed significant difference in the three severity groups. There was no significant change in the measures over time or difference in the longitudinal change between groups. During this same period, there were no clinically significant changes in disease status observed within any individuals as measured by EDSS.
Conclusions: This study demonstrated that a novel digital biosensor signature correlated with baseline physician severity ratings using EDSS. The biosensor data was acquired without patient effort in the free-living environment, suggesting that home biosensor tracking may substitute for, or supplement in-office physician assessment for monitoring MS.
Disclosure: Cindy Gonzalez received research support from Verily Life Sciences. Dr. Healy has received research support from Merck Serono, Genzyme, Novartis, and Verily Life Sciences. Dr. Glanz received research support from Verily Life Sciences. Taylor J. Saraceno received research support from Verily Life Sciences. Dr. Sattarnezhad received research support from Verily Life Sciences and Serono. Dr. Diaz-Cruz received research support from Verily Life Sciences and Serono. Mariann Polgar-Turcsanyi has nothing to disclose. Dr. Tummala has nothing to disclose. Dr. Bakshi has received consulting fees from Bayer, EMD Serono, Genentech, Guerbet, Sanofi-Genzyme, and Shire and research support from EMD Serono and Sanofi-Genzyme. David Ben-Shimol is an employee and equity holders at Verily Life Sciences. Nikhil Bikhchandani is an employee and equity holders at Verily Life Sciences.Joshua Burkart is an employee and equity holders at Verily Life Sciences. Michael Cusack is an employee and equity holders at Verily Life Sciences. Emre Demiralp is an employee and equity holders at Verily Life Sciences. Alaa Kharbouch is an employee and equity holders at Verily Life Sciences. Amy A. Lee is an employee and equity holders at Verily Life Sciences. Manway Liu is an employee and equity holders at Verily Life Sciences. Swaminathan Mahadevan is an employee and equity holders at Verily Life Sciences. Linda C. Norton is an employee and equity holders at Verily Life Sciences. Tushar A. Parlikar is an employee and equity holders at Verily Life Sciences. Anupam Pathak is an employee and equity holders at Verily Life Sciences. Ali Shoeb is an employee and equity holders at Verily Life Sciences. Erin Soderberg is an employee and equity holders at Verily Life Sciences. Philip Stephens is an employee and equity holders at Verily Life Sciences. Aaron H. Stoertz is an employee and equity holders at Verily Life Sciences. Florence Thng is an employee and equity holders at Verily Life Sciences. Kashyap Tumkur is an employee and equity holders at Verily Life Sciences. Hongsheng Wang is an employee and equity holders at Verily Life Sciences. Jane Rhodes was an employee at Biogen during the study period. Dr. Rudick is an employee of Biogen and holds stock and/or stock options in the company. Richard M. Ransohoff was an employee at Biogen during the study period. Glenn A. Phillips was an employee at Biogen during the study period.
Effie Bruzik is an employee at Biogen. William J. Marks is an employee and equity holders at Verily Life Sciences. Dr. Weiner has research support from NIH, NMSS, Verily Life Sciences, EMD Serono, Biogen, Teva Pharmaceuticals, Sanofi, and Novartis. Research support and consulting fees from Genentech, Inc., Tilos Therapeutics, Tiziana Life Sciences, and IM Therapeutics. Personal and consulting fees from vTv Therapeutics and MedDay Pharmaceuticals. Thomas M. Snyder is an employee and equity holders at Verily Life Sciences. Dr. Chitnis has served on the advisory boards for clinical trials sponsored by Novartis and Sanofi-Genzyme, and has received consulting/advisory fees from Bayer, Biogen, Celgene, Genentech-Roche, Novartis and Sanofi-Genzyme. She has received research grant support from Biogen, Octave, Serono and Verily.