Contributions
Abstract: EP1513
Type: Poster Sessions
Abstract Category: Pathology and pathogenesis of MS - MRI and PET
Objective: To compare brain atrophy rates for multiple sclerosis (MS) patients treated for ≥2 years with fingolimod (FTY) vs. age and gender matched MS patients on glatiramer acetate (GA) in a prospective two-year study examining brain volume, cognition and patient reported outcomes (PROs).
Background: Clinically stable MS patients on long-term FTY therapy often have little if any overt inflammation on MRI. Brain atrophy rates may provide insight into subclinical disease progression in these populations and may determine whether long-term FTY patients have brain volume loss that is different to patients on GA.
Methods: Relapsing MS patients, age 18-60, on FTY and GA for >2 years were followed prospectively for two years. MRI outcomes, cognitive measures, and PROs were collected yearly. Baseline normalized brain volume (NBV), yearly T2 lesion volume (T2LV), and percent brain volume change (PBVC) were measured using SIENA, JIM 6.0, and SIENAX respectively and correlated with cognitive measures (including Paced Auditory Serial Addition Test (PASAT), Symbol Digit Modalities Test (SDMT)) and PROs (including Neuro-QOL scales). Statistical analyses were conducted in SAS 9.4.
Results: Forty-three FTY and 43 GA patients completed baseline, 12, and 24 month visits. Mean age is 49.2FTY (+/- 7.7) and 49.7GA years (+/- 7.7, p=0.73); 79.1%FTY vs.79.1%GA were female (p=1.00). Median EDSS score was 2.50FTY (IQR 2.00, 3.00) and 2.00GA (IQR 1.50, 3.00) (p=0.22) while mean disease duration was 13.1FTY (+/-4.3) and 11.0GA years (+/-6.6, p=0.09). Unadjusted NBV was similar at baseline for this subset (FTY=1491.67cm3 vs. GA=1507.97cm3; p=0.30); as was baseline T2LV (FTY=3211.51mm3 vs. GA=1443.08mm3; p=< 0.0075). The mean unadjusted 24 month PBVC for FTY was -0.60% (p< 0.0001) and -0.57% (p< 0.0001) for GA. The mean PBVC, adjusted for gender (averaged), baseline age (47 years old), and baseline brain volume (1520cm3) for FTY was -0.74% (p< 0.0001) and -0.65% (p< 0.0001) for GA. The PBVC between these groups were not statistically significant -0.088% (p=0.64). Relationships to cognitive testing and PROs will be presented.
Conclusion: There is no evidence patients on FTY and GA for >2 years have different brain volume loss. We report brain volume loss rates comparable to rates previously reported for healthy nonMS patients, which suggests normalization of brain volume loss compared to MS patients who have been stable >2 years.
Support: Novartis
Disclosure: Justin Honce has consulted for Genetech and has received research support from Biogen and Novartis. Kavita V Nair has consulted and/or received research support from Astellas, Genentech, Novartis, and Biogen; consulting for Astellas and Genentech. Brian Hoyt has nothing to disclose. Stefan H Sillau has nothing to disclose. John Corboy has received grant support from Biogen Idec, Novartis, Med Day, NMSS, and PCORI, has received honorarium for speaking from the Rocky Mountain MS Center and PRIME CME, and has received compensation as editor of Neurology: Clinical Practice. Timothy Vollmer has received compensation for activities such as advisory boards, lectures and consultancy with Academic CME; Alcimed; Anthem Blue Cross; Genentech/Roche; Biogen IDEC; Novartis; CellGene; Epigene; Rocky Mountain MS Center;GLG Consulting; Ohio Health; TG Therapeutics; Topaz Therapeutics; Deleara Lawyers; Teva Neuroscience He received research support from Teva Neuroscience; NIH/NINDS; Rocky Mountain MS Center; Actelion; Roche/Genentech; UT Southwestern and TG Therapeutics, Inc. Enrique Alvarez: has consulted for Biogen, Genzyme, Genentech, Teva, and Novartis; and received research funding from Rocky Mountain MS Center, Biogen, Novartis, Acorda, and Alkermes.
Abstract: EP1513
Type: Poster Sessions
Abstract Category: Pathology and pathogenesis of MS - MRI and PET
Objective: To compare brain atrophy rates for multiple sclerosis (MS) patients treated for ≥2 years with fingolimod (FTY) vs. age and gender matched MS patients on glatiramer acetate (GA) in a prospective two-year study examining brain volume, cognition and patient reported outcomes (PROs).
Background: Clinically stable MS patients on long-term FTY therapy often have little if any overt inflammation on MRI. Brain atrophy rates may provide insight into subclinical disease progression in these populations and may determine whether long-term FTY patients have brain volume loss that is different to patients on GA.
Methods: Relapsing MS patients, age 18-60, on FTY and GA for >2 years were followed prospectively for two years. MRI outcomes, cognitive measures, and PROs were collected yearly. Baseline normalized brain volume (NBV), yearly T2 lesion volume (T2LV), and percent brain volume change (PBVC) were measured using SIENA, JIM 6.0, and SIENAX respectively and correlated with cognitive measures (including Paced Auditory Serial Addition Test (PASAT), Symbol Digit Modalities Test (SDMT)) and PROs (including Neuro-QOL scales). Statistical analyses were conducted in SAS 9.4.
Results: Forty-three FTY and 43 GA patients completed baseline, 12, and 24 month visits. Mean age is 49.2FTY (+/- 7.7) and 49.7GA years (+/- 7.7, p=0.73); 79.1%FTY vs.79.1%GA were female (p=1.00). Median EDSS score was 2.50FTY (IQR 2.00, 3.00) and 2.00GA (IQR 1.50, 3.00) (p=0.22) while mean disease duration was 13.1FTY (+/-4.3) and 11.0GA years (+/-6.6, p=0.09). Unadjusted NBV was similar at baseline for this subset (FTY=1491.67cm3 vs. GA=1507.97cm3; p=0.30); as was baseline T2LV (FTY=3211.51mm3 vs. GA=1443.08mm3; p=< 0.0075). The mean unadjusted 24 month PBVC for FTY was -0.60% (p< 0.0001) and -0.57% (p< 0.0001) for GA. The mean PBVC, adjusted for gender (averaged), baseline age (47 years old), and baseline brain volume (1520cm3) for FTY was -0.74% (p< 0.0001) and -0.65% (p< 0.0001) for GA. The PBVC between these groups were not statistically significant -0.088% (p=0.64). Relationships to cognitive testing and PROs will be presented.
Conclusion: There is no evidence patients on FTY and GA for >2 years have different brain volume loss. We report brain volume loss rates comparable to rates previously reported for healthy nonMS patients, which suggests normalization of brain volume loss compared to MS patients who have been stable >2 years.
Support: Novartis
Disclosure: Justin Honce has consulted for Genetech and has received research support from Biogen and Novartis. Kavita V Nair has consulted and/or received research support from Astellas, Genentech, Novartis, and Biogen; consulting for Astellas and Genentech. Brian Hoyt has nothing to disclose. Stefan H Sillau has nothing to disclose. John Corboy has received grant support from Biogen Idec, Novartis, Med Day, NMSS, and PCORI, has received honorarium for speaking from the Rocky Mountain MS Center and PRIME CME, and has received compensation as editor of Neurology: Clinical Practice. Timothy Vollmer has received compensation for activities such as advisory boards, lectures and consultancy with Academic CME; Alcimed; Anthem Blue Cross; Genentech/Roche; Biogen IDEC; Novartis; CellGene; Epigene; Rocky Mountain MS Center;GLG Consulting; Ohio Health; TG Therapeutics; Topaz Therapeutics; Deleara Lawyers; Teva Neuroscience He received research support from Teva Neuroscience; NIH/NINDS; Rocky Mountain MS Center; Actelion; Roche/Genentech; UT Southwestern and TG Therapeutics, Inc. Enrique Alvarez: has consulted for Biogen, Genzyme, Genentech, Teva, and Novartis; and received research funding from Rocky Mountain MS Center, Biogen, Novartis, Acorda, and Alkermes.