Contributions
Abstract: P1226
Type: Poster
Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response
Background: Sensor-based, high-yield active and passive monitoring may be more sensitive and specific than periodic in-clinic assessments to measure progression in multiple sclerosis (MS). We present correlations between smartphone-based and in-clinic assessments of cognitive and physical measures in patients with MS.
Objective: To report interim analysis of correlations between smartphone-based and in-clinic tests from the FLOODLIGHT (NCT02952911) study.
Methods: Patients with MS (McDonald 2010 criteria; 18-55 years; Expanded Disability Status Scale [EDSS]=0-5.5; n=80) and healthy controls (n=40) received a preconfigured smartphone and smartwatch that prompt the user to perform the FLOODLIGHT test battery, comprising 'active tests' (daily hand motor function, gait and static balance tests; weekly cognitive tests; and patient-reported outcomes) and 'passive monitoring' (ongoing collection of metrics on gait and mobility), for 24 weeks. The primary endpoint assessed participants' adherence. In-clinic tests (e.g. EDSS, 9-hole peg test, Symbol Digit Modalities Test (SDMT), Timed 25-Foot Walk (T25FW), Berg balance scale) and brain MRI assessments were performed. The secondary endpoint explored whether data collected using the smartphone- and smartwatch-based remote monitoring are significantly different between MS and healthy controls and correlate with in-clinic visit clinical outcomes. The correlation between smartphone-based and in-clinic tests was reported using Spearman's correlation coefficient (SCC).
Results: As of 27 March 2017, the first baseline cross-sectional interim analysis of 30 patients showed correlation between the number of correct responses in the smartphone-based SDMT vs the oral SDMT (SCC=0.73, p< 0.001) and MS Impact Scale (MSIS)-29 total score (SCC=-0.52, p=0.003). Turning speed measured with the smartphone-based Five U-Turn Test correlated with the T25FW (n=28, SCC=-0.62, p< 0.001) as well as the ambulation items of the MSIS-29 (n=29, SCC=-0.64, p< 0.001). A longitudinal interim analysis of adherence and further correlations between baseline FLOODLIGHT sensor-based and in-clinic testing data will be presented.
Conclusions: Initial analysis of data from FLOODLIGHT indicates smartphone-based assessments are consistently correlated with in-clinic tests. FLOODLIGHT will further inform on the feasibility of integrating minimally intrusive and self-administered digital technologies into patients' daily routines for enhanced precision monitoring of MS disease.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Health Interactions, USA, and Articulate Science, UK.
P. Mulero has nothing to disclose.
L. Midaglia has nothing to disclose.
X. Montalban has received speaking honoraria and travel expense reimbursement for participation in scientific meetings, and has been a steering committee member or participated in advisory boards of clinical trials for Actelion, Almirall, Bayer, Biogen, Genzyme, Merck, Novartis, Octapharma, Receptos, F. Hoffmann-La Roche Ltd, Sanofi, Teva and Trophos.
J. Graves has received grants or research support from Genentech, Biogen and S3 Group, and resident and fellow non-branded education seminar supported by Biogen.
S.L. Hauser serves on the board of trustees for Neurona and on scientific advisory boards for Annexon, Symbiotix and Bionure; he has also received travel reimbursement and writing assistance from F. Hoffmann-La Roche Ltd for CD20-related meetings and presentations.
L. Julian is an employee and shareholder of Genentech, Inc.
M. Baker is an employee and shareholder of F. Hoffmann-La Roche Ltd.
J. Schadrack is an employee and shareholder of F. Hoffmann-La Roche Ltd.
C. Gossens is an employee and shareholder of F. Hoffmann-La Roche Ltd.
A. Scotland is an employee of F. Hoffmann-La Roche Ltd.
F. Lipsmeier is an employee and shareholder of F. Hoffmann-La Roche Ltd.
A. Creagh is an employee and shareholder of F. Hoffmann-La Roche Ltd.
C. Bernasconi is a contractor of F. Hoffmann-La Roche Ltd.
S. Belachew is an employee and shareholder of F. Hoffmann-La Roche Ltd.
M. Lindemann has nothing to disclose.
Abstract: P1226
Type: Poster
Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response
Background: Sensor-based, high-yield active and passive monitoring may be more sensitive and specific than periodic in-clinic assessments to measure progression in multiple sclerosis (MS). We present correlations between smartphone-based and in-clinic assessments of cognitive and physical measures in patients with MS.
Objective: To report interim analysis of correlations between smartphone-based and in-clinic tests from the FLOODLIGHT (NCT02952911) study.
Methods: Patients with MS (McDonald 2010 criteria; 18-55 years; Expanded Disability Status Scale [EDSS]=0-5.5; n=80) and healthy controls (n=40) received a preconfigured smartphone and smartwatch that prompt the user to perform the FLOODLIGHT test battery, comprising 'active tests' (daily hand motor function, gait and static balance tests; weekly cognitive tests; and patient-reported outcomes) and 'passive monitoring' (ongoing collection of metrics on gait and mobility), for 24 weeks. The primary endpoint assessed participants' adherence. In-clinic tests (e.g. EDSS, 9-hole peg test, Symbol Digit Modalities Test (SDMT), Timed 25-Foot Walk (T25FW), Berg balance scale) and brain MRI assessments were performed. The secondary endpoint explored whether data collected using the smartphone- and smartwatch-based remote monitoring are significantly different between MS and healthy controls and correlate with in-clinic visit clinical outcomes. The correlation between smartphone-based and in-clinic tests was reported using Spearman's correlation coefficient (SCC).
Results: As of 27 March 2017, the first baseline cross-sectional interim analysis of 30 patients showed correlation between the number of correct responses in the smartphone-based SDMT vs the oral SDMT (SCC=0.73, p< 0.001) and MS Impact Scale (MSIS)-29 total score (SCC=-0.52, p=0.003). Turning speed measured with the smartphone-based Five U-Turn Test correlated with the T25FW (n=28, SCC=-0.62, p< 0.001) as well as the ambulation items of the MSIS-29 (n=29, SCC=-0.64, p< 0.001). A longitudinal interim analysis of adherence and further correlations between baseline FLOODLIGHT sensor-based and in-clinic testing data will be presented.
Conclusions: Initial analysis of data from FLOODLIGHT indicates smartphone-based assessments are consistently correlated with in-clinic tests. FLOODLIGHT will further inform on the feasibility of integrating minimally intrusive and self-administered digital technologies into patients' daily routines for enhanced precision monitoring of MS disease.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Health Interactions, USA, and Articulate Science, UK.
P. Mulero has nothing to disclose.
L. Midaglia has nothing to disclose.
X. Montalban has received speaking honoraria and travel expense reimbursement for participation in scientific meetings, and has been a steering committee member or participated in advisory boards of clinical trials for Actelion, Almirall, Bayer, Biogen, Genzyme, Merck, Novartis, Octapharma, Receptos, F. Hoffmann-La Roche Ltd, Sanofi, Teva and Trophos.
J. Graves has received grants or research support from Genentech, Biogen and S3 Group, and resident and fellow non-branded education seminar supported by Biogen.
S.L. Hauser serves on the board of trustees for Neurona and on scientific advisory boards for Annexon, Symbiotix and Bionure; he has also received travel reimbursement and writing assistance from F. Hoffmann-La Roche Ltd for CD20-related meetings and presentations.
L. Julian is an employee and shareholder of Genentech, Inc.
M. Baker is an employee and shareholder of F. Hoffmann-La Roche Ltd.
J. Schadrack is an employee and shareholder of F. Hoffmann-La Roche Ltd.
C. Gossens is an employee and shareholder of F. Hoffmann-La Roche Ltd.
A. Scotland is an employee of F. Hoffmann-La Roche Ltd.
F. Lipsmeier is an employee and shareholder of F. Hoffmann-La Roche Ltd.
A. Creagh is an employee and shareholder of F. Hoffmann-La Roche Ltd.
C. Bernasconi is a contractor of F. Hoffmann-La Roche Ltd.
S. Belachew is an employee and shareholder of F. Hoffmann-La Roche Ltd.
M. Lindemann has nothing to disclose.