Contributions
Abstract: P336
Type: Poster
Abstract Category: Clinical aspects of MS - 5 Epidemiology
Background: MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions), a network of 10 healthcare institutions in the United States and Europe, was designed around the concept of a Learning Health System (LHS), merging research with ongoing patient care by collecting standardized clinical and imaging data during routine medical visits.
Objectives: To report initial demographic and clinical characteristics of patients participating in MS PATHS.
Methods: During routine visits, patients used an iPad-based device, the Multiple Sclerosis Performance Test (MSPT), to self-administer an MS history, including disease severity measured by the Patient Determined Disease Steps (PDDS), 12 subscales of the Quality of Life in Neurological Disorders (Neuro-QoL) instrument, and an electronic adaptation of the MSFC: a processing speed test (PST), similar to the Symbol Digit Modalities Test; a manual dexterity test (MDT), similar to the 9-hole peg test; and a 25-foot walking speed test (WST), similar to the timed 25-foot walk. Standardized MRIs were acquired on Siemens 3T scanners and participants could elect to provide samples to a biorepository.
Results: Data from the first 2017 quarterly release indicate the MS PATHS cohort (n=1353) is predominately white (85%) and female (72%), with a majority self-reporting a relapsing remitting disease course (62%). The mean (SD) age was 48.9 years (12.0) and mean (SD) disease duration was 12.2 years (9.4). PDDS was normal (29%), mild (19%) or moderate disability (11%), gait disability (12%), early cane (10%), late cane (7%), bilateral support (7%) or wheelchair/scooter (6%). The mean (SD, range) PST was 45.9 correct (13.2, 4-86), mean (SD, range) MDT was 28.8 seconds (7.1, 17.2-55.8) and mean (SD, range) WST was 8.1 seconds (5.4, 2-52.5). Patient reported symptoms in the moderate to severe range on Neuro-Qol included fatigue (53.3%), lower extremity function problems (37.3%), upper limb function problems (24.5%) and sleep disturbance (19.9%). Updated data will be presented.
Conclusions: MS PATHS is the first LHS established in MS. Patient engagement has been strong with participation rates >90%, suggesting the MS PATHS cohort is likely representative of MS patients seeking care at MS centers. The unique combination of patient reported outcomes, quantitative performance measures, standardized MRI and laboratory data should enable collaborative research and accelerate efforts to achieve personalized medicine in MS.
Disclosure: Project funded by Biogen, Inc.
Author disclosures:
Ellen Mowry has received research funding from Biogen and free medication for a clinical trial from Teva Neuroscience. She is a site PI for trials funded by Biogen and Sun Pharma, and receives royalties for editorial duties with UpToDate.
Lauren Krupp has received consultant fees from EMD Serono, Projects in Knowledge, Novartis, Pfizer (for serving on a DSMB), Biogen, PK Law and Teva Neurosciences; Royalty payments from Abbvie Inc. and Grifols World Wide Services; and research grant support from Novartis, Teva Neurosciences, Biogen, NIH, National Multiple Sclerosis Society, Department of Defense and the Lourie Foundation.
Robert Bermel has received consulting fees from Biogen, Novartis, Genentech, Genzyme and Mallinckrodt, and is part contributor to the intellectual property used in the MSPT.
Stephen Jones has received a speaker fee from Monteris and Siemens.
Robert Naismith has received consulting fees and/or honoraria from Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genzyme, Novartis and Teva.
Aaron Boster has received consulting fees and/or honoraria from Teva, Biogen, Novartis, Genzyme, Mallinckrodt and Medtronic.
Megan Hyland is employed by the University of Rochester which receives funding from Biogen, Chugai and Novartis.
Izlem Izbudak and Yvonne W. Lui have nothing to disclose.
Tammie Benzinger has received research support/grants and consulting/advisory board fees from Eli Lilly.
Carrie Hersh has received speaking and consulting fees from Genzyme and Teva, and grant funding from Genentech.
Bjorn Tackenberg is on the scientific advisory boards for CSL Behring, Grifols, Biogen, Novartis, Bayer Healthcare, Genzyme, and UCB; received speaker honoraria from CSL Behring, Grifols, Octapharma, Biogen, Novartis, Bayer Healthcare, and Genzyme; has consulted for CSL Behring, Grifols, Biogen, Novartis, Bayer Healthcare, Genzyme, and UCB; and received research support from Biogen and Novartis.
Tjalf Ziemssen has received speaker honoraria and travel expenses for scientific meetings and has been a steering committee member of clinical trials or participated in advisory boards for clinical trials for Almirall, Bayer Schering Pharma, Biogen Idec, EMD Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis and Teva Pharmaceuticals.
Kendra Buzzell, Carl de Moor, Elizabeth Fisher, Bernd C. Kieseier, Kate Murphy, Himanshu Pandya, Glenn A. Phillips, Jane Rhodes, James R. Williams and Richard Rudick are employees of, and stockholders in, Biogen.
Xavier Montalban has received speaking honoraria and travel expenses for participation in scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in recent years with Actelion, Almirall, Bayer, Biogen, Celgene, Genzyme, Merck, Novartis, Oryzon, Roche, Sanofi-Genzyme and Teva Pharmaceuticals.
Abstract: P336
Type: Poster
Abstract Category: Clinical aspects of MS - 5 Epidemiology
Background: MS PATHS (Multiple Sclerosis Partners Advancing Technology and Health Solutions), a network of 10 healthcare institutions in the United States and Europe, was designed around the concept of a Learning Health System (LHS), merging research with ongoing patient care by collecting standardized clinical and imaging data during routine medical visits.
Objectives: To report initial demographic and clinical characteristics of patients participating in MS PATHS.
Methods: During routine visits, patients used an iPad-based device, the Multiple Sclerosis Performance Test (MSPT), to self-administer an MS history, including disease severity measured by the Patient Determined Disease Steps (PDDS), 12 subscales of the Quality of Life in Neurological Disorders (Neuro-QoL) instrument, and an electronic adaptation of the MSFC: a processing speed test (PST), similar to the Symbol Digit Modalities Test; a manual dexterity test (MDT), similar to the 9-hole peg test; and a 25-foot walking speed test (WST), similar to the timed 25-foot walk. Standardized MRIs were acquired on Siemens 3T scanners and participants could elect to provide samples to a biorepository.
Results: Data from the first 2017 quarterly release indicate the MS PATHS cohort (n=1353) is predominately white (85%) and female (72%), with a majority self-reporting a relapsing remitting disease course (62%). The mean (SD) age was 48.9 years (12.0) and mean (SD) disease duration was 12.2 years (9.4). PDDS was normal (29%), mild (19%) or moderate disability (11%), gait disability (12%), early cane (10%), late cane (7%), bilateral support (7%) or wheelchair/scooter (6%). The mean (SD, range) PST was 45.9 correct (13.2, 4-86), mean (SD, range) MDT was 28.8 seconds (7.1, 17.2-55.8) and mean (SD, range) WST was 8.1 seconds (5.4, 2-52.5). Patient reported symptoms in the moderate to severe range on Neuro-Qol included fatigue (53.3%), lower extremity function problems (37.3%), upper limb function problems (24.5%) and sleep disturbance (19.9%). Updated data will be presented.
Conclusions: MS PATHS is the first LHS established in MS. Patient engagement has been strong with participation rates >90%, suggesting the MS PATHS cohort is likely representative of MS patients seeking care at MS centers. The unique combination of patient reported outcomes, quantitative performance measures, standardized MRI and laboratory data should enable collaborative research and accelerate efforts to achieve personalized medicine in MS.
Disclosure: Project funded by Biogen, Inc.
Author disclosures:
Ellen Mowry has received research funding from Biogen and free medication for a clinical trial from Teva Neuroscience. She is a site PI for trials funded by Biogen and Sun Pharma, and receives royalties for editorial duties with UpToDate.
Lauren Krupp has received consultant fees from EMD Serono, Projects in Knowledge, Novartis, Pfizer (for serving on a DSMB), Biogen, PK Law and Teva Neurosciences; Royalty payments from Abbvie Inc. and Grifols World Wide Services; and research grant support from Novartis, Teva Neurosciences, Biogen, NIH, National Multiple Sclerosis Society, Department of Defense and the Lourie Foundation.
Robert Bermel has received consulting fees from Biogen, Novartis, Genentech, Genzyme and Mallinckrodt, and is part contributor to the intellectual property used in the MSPT.
Stephen Jones has received a speaker fee from Monteris and Siemens.
Robert Naismith has received consulting fees and/or honoraria from Acorda, Alkermes, Bayer, Biogen, EMD Serono, Genentech, Genzyme, Novartis and Teva.
Aaron Boster has received consulting fees and/or honoraria from Teva, Biogen, Novartis, Genzyme, Mallinckrodt and Medtronic.
Megan Hyland is employed by the University of Rochester which receives funding from Biogen, Chugai and Novartis.
Izlem Izbudak and Yvonne W. Lui have nothing to disclose.
Tammie Benzinger has received research support/grants and consulting/advisory board fees from Eli Lilly.
Carrie Hersh has received speaking and consulting fees from Genzyme and Teva, and grant funding from Genentech.
Bjorn Tackenberg is on the scientific advisory boards for CSL Behring, Grifols, Biogen, Novartis, Bayer Healthcare, Genzyme, and UCB; received speaker honoraria from CSL Behring, Grifols, Octapharma, Biogen, Novartis, Bayer Healthcare, and Genzyme; has consulted for CSL Behring, Grifols, Biogen, Novartis, Bayer Healthcare, Genzyme, and UCB; and received research support from Biogen and Novartis.
Tjalf Ziemssen has received speaker honoraria and travel expenses for scientific meetings and has been a steering committee member of clinical trials or participated in advisory boards for clinical trials for Almirall, Bayer Schering Pharma, Biogen Idec, EMD Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis and Teva Pharmaceuticals.
Kendra Buzzell, Carl de Moor, Elizabeth Fisher, Bernd C. Kieseier, Kate Murphy, Himanshu Pandya, Glenn A. Phillips, Jane Rhodes, James R. Williams and Richard Rudick are employees of, and stockholders in, Biogen.
Xavier Montalban has received speaking honoraria and travel expenses for participation in scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in recent years with Actelion, Almirall, Bayer, Biogen, Celgene, Genzyme, Merck, Novartis, Oryzon, Roche, Sanofi-Genzyme and Teva Pharmaceuticals.