Abstract: P943
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Background: SymptoMScreen is a new patient-reported outcome (PRO) tool for the rapid assessment of multiple sclerosis (MS) symptom severity in 12 domains (walking, hand function/dexterity, spasticity, bodily pain, sensory, bladder, fatigue, vision, dizziness, cognitive, depression and anxiety) on 7-point Likert scales (0 [not affected] to 6 [total limitation]). SymptoMScreen is used for the first time as an outcome measure in two ongoing, open-label, single-arm Phase IIIb clinical trials of ocrelizumab (OCR) in treatment naive patients with early-stage relapsing-remitting MS (RRMS; ENSEMBLE [NCT03085810]) and patients with RRMS who had a prior suboptimal response to disease-modifying treatment (DMT; CASTING [NCT02861014]).
Objective: To report ENSEMBLE and CASTING baseline SymptoMScreen results.
Methods: Patients in ENSEMBLE (Expanded Disability Status Scale [EDSS] score ≤3.5 at screening) had a disease duration of ≤3 years and ≥1 clinically reported relapse or ≥1 sign of MRI activity within 12 months of enrolment; patients in CASTING (EDSS ≤4.0 at screening) had a disease duration ≤10 years and discontinued a prior DMT of ≥6 months' duration for reasons of suboptimal disease control. SymptoMScreen was performed in all study patients at baseline. OCR 600mg/24 weeks (first dose, 2×300mg, 14 days apart) was administered intravenously in both ENSEMBLE (192 weeks; maximum 8 doses) and CASTING (96 weeks; maximum 4 doses).
Results: ENSEMBLE patient (N=676) baseline characteristics were: female=65%, mean (SD) baseline EDSS score=1.7 (1.0), disease duration=1.1 (0.9) years; and in CASTING (N=681): female=64%, baseline EDSS score=2.1 (1.1), disease duration=5.0 (2.7) years. In CASTING, 61% of patients had received one DMT prior to enrolment (most frequently dimethyl fumarate [25%]). Total mean (SD) baseline SymptoMScreen scores were 12.2 (10.9) in ENSEMBLE and 15.3 (12.6) in CASTING; individual domain scores ranged from 0.8 (1.1) to 1.8 (1.5) and 1.0 (1.2) to 2.1 (1.6), respectively, with numerically higher scores in ENSEMBLE (all domains) and fatigue having the highest score in both studies. Moderate to severe fatigue (domain score ≥3) was reported in 31% (ENSEMBLE) to 41% (CASTING) of patients.
Conclusions: SymptoMScreen scores were generally low, though expectedly higher in CASTING than ENSEMBLE, consistent with greater disability in the patients who experienced suboptimal control; differences were consistent in all domains, but were most pronounced in fatigue and ambulation.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK.
I. Kister - served on scientific advisory board for Biogen Idec and Genentech and received research support from Guthy-Jackson Charitable Foundation, National Multiple Sclerosis Society, Biogen-Idec, Serono, Genzyme and Novartis.
H. P. Hartung has received honoraria for consulting, serving on steering committees and speaking at scientific symposia with approval by the Rector of Heinrich-Heine University Düsseldorf from Bayer, Biogen, F. Hoffmann-La Roche Ltd, GeNeuro SA, Genzyme, MedImmune, Merck Serono, Novartis, Octapharma, Opexa, Teva and Sanofi.
P. Vermersch has received financial grant/research support from Biogen, Celgene, F. Hoffmann-La Roche Ltd, Genzyme and Merck and has received consulting fees from Almirall, Biogen, F. Hoffmann-La Roche Ltd, Genzyme, Novartis and Servier.
R. Buffels is an employee of F. Hoffmann-La Roche Ltd.
R. Kuhelj is an employee of F. Hoffmann-La Roche Ltd.
F. McDougall is an employee and shareholder of F. Hoffmann-La Roche Ltd.
W. Wei is an employee and shareholder of F. Hoffmann-La Roche Ltd.
G. Cutter has served on data and safety monitoring boards for AMO Pharmaceuticals, Biolinerx, Horizon Pharmaceuticals, Merck, Merck/Pfizer, Opko Biologics, Neurim, Ophazyme, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva pharmaceuticals, NHLBI (Protocol Review Committee), NICHD (OPRU oversight committee); and has served on consulting or advisory boards for Atara Biotherapeutics, Axon, Biogen, Biotherapeutics, Argenix, Brainstorm Cell Therapeutics, Charleston Labs Inc, Click Therapeutics, Genzyme, Genentech, GW Pharma, Klein-Buendel Inc., Medimmune, Medday, Novartis, Roche, Scifluor, Somahlution, Teva pharmaceuticals, TG Therapeutics, and UT Houston. Dr. Cutter is employed by the University of Alabama at Birmingham and is president of Pythagoras, Inc., a private consulting company located in Birmingham, AL, USA.
Abstract: P943
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Background: SymptoMScreen is a new patient-reported outcome (PRO) tool for the rapid assessment of multiple sclerosis (MS) symptom severity in 12 domains (walking, hand function/dexterity, spasticity, bodily pain, sensory, bladder, fatigue, vision, dizziness, cognitive, depression and anxiety) on 7-point Likert scales (0 [not affected] to 6 [total limitation]). SymptoMScreen is used for the first time as an outcome measure in two ongoing, open-label, single-arm Phase IIIb clinical trials of ocrelizumab (OCR) in treatment naive patients with early-stage relapsing-remitting MS (RRMS; ENSEMBLE [NCT03085810]) and patients with RRMS who had a prior suboptimal response to disease-modifying treatment (DMT; CASTING [NCT02861014]).
Objective: To report ENSEMBLE and CASTING baseline SymptoMScreen results.
Methods: Patients in ENSEMBLE (Expanded Disability Status Scale [EDSS] score ≤3.5 at screening) had a disease duration of ≤3 years and ≥1 clinically reported relapse or ≥1 sign of MRI activity within 12 months of enrolment; patients in CASTING (EDSS ≤4.0 at screening) had a disease duration ≤10 years and discontinued a prior DMT of ≥6 months' duration for reasons of suboptimal disease control. SymptoMScreen was performed in all study patients at baseline. OCR 600mg/24 weeks (first dose, 2×300mg, 14 days apart) was administered intravenously in both ENSEMBLE (192 weeks; maximum 8 doses) and CASTING (96 weeks; maximum 4 doses).
Results: ENSEMBLE patient (N=676) baseline characteristics were: female=65%, mean (SD) baseline EDSS score=1.7 (1.0), disease duration=1.1 (0.9) years; and in CASTING (N=681): female=64%, baseline EDSS score=2.1 (1.1), disease duration=5.0 (2.7) years. In CASTING, 61% of patients had received one DMT prior to enrolment (most frequently dimethyl fumarate [25%]). Total mean (SD) baseline SymptoMScreen scores were 12.2 (10.9) in ENSEMBLE and 15.3 (12.6) in CASTING; individual domain scores ranged from 0.8 (1.1) to 1.8 (1.5) and 1.0 (1.2) to 2.1 (1.6), respectively, with numerically higher scores in ENSEMBLE (all domains) and fatigue having the highest score in both studies. Moderate to severe fatigue (domain score ≥3) was reported in 31% (ENSEMBLE) to 41% (CASTING) of patients.
Conclusions: SymptoMScreen scores were generally low, though expectedly higher in CASTING than ENSEMBLE, consistent with greater disability in the patients who experienced suboptimal control; differences were consistent in all domains, but were most pronounced in fatigue and ambulation.
Disclosure: Sponsored by F. Hoffmann-La Roche Ltd; writing and editorial assistance was provided by Articulate Science, UK.
I. Kister - served on scientific advisory board for Biogen Idec and Genentech and received research support from Guthy-Jackson Charitable Foundation, National Multiple Sclerosis Society, Biogen-Idec, Serono, Genzyme and Novartis.
H. P. Hartung has received honoraria for consulting, serving on steering committees and speaking at scientific symposia with approval by the Rector of Heinrich-Heine University Düsseldorf from Bayer, Biogen, F. Hoffmann-La Roche Ltd, GeNeuro SA, Genzyme, MedImmune, Merck Serono, Novartis, Octapharma, Opexa, Teva and Sanofi.
P. Vermersch has received financial grant/research support from Biogen, Celgene, F. Hoffmann-La Roche Ltd, Genzyme and Merck and has received consulting fees from Almirall, Biogen, F. Hoffmann-La Roche Ltd, Genzyme, Novartis and Servier.
R. Buffels is an employee of F. Hoffmann-La Roche Ltd.
R. Kuhelj is an employee of F. Hoffmann-La Roche Ltd.
F. McDougall is an employee and shareholder of F. Hoffmann-La Roche Ltd.
W. Wei is an employee and shareholder of F. Hoffmann-La Roche Ltd.
G. Cutter has served on data and safety monitoring boards for AMO Pharmaceuticals, Biolinerx, Horizon Pharmaceuticals, Merck, Merck/Pfizer, Opko Biologics, Neurim, Ophazyme, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva pharmaceuticals, NHLBI (Protocol Review Committee), NICHD (OPRU oversight committee); and has served on consulting or advisory boards for Atara Biotherapeutics, Axon, Biogen, Biotherapeutics, Argenix, Brainstorm Cell Therapeutics, Charleston Labs Inc, Click Therapeutics, Genzyme, Genentech, GW Pharma, Klein-Buendel Inc., Medimmune, Medday, Novartis, Roche, Scifluor, Somahlution, Teva pharmaceuticals, TG Therapeutics, and UT Houston. Dr. Cutter is employed by the University of Alabama at Birmingham and is president of Pythagoras, Inc., a private consulting company located in Birmingham, AL, USA.