Contributions
Abstract: EP1412
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Clinical assessment tools
Introduction: Cognitive impairment affects many patients with multiple sclerosis (MS). In a previous analysis using NeuroTrax to assess cognitive changes from baseline to 2 years in patients initiating natalizumab, patients demonstrated a significant improvement (mean change from baseline in global cognitive score [GCS], 3.4; P=0.003; N=52), and 32.7% of patients demonstrated clinically significant improvement in GCS (previously defined as an increase from baseline >1 standard deviation [SD]) at year 2.
Objectives: Evaluate changes in cognitive function assessed using NeuroTrax in patients on natalizumab treatment for up to 5 years.
Methods: This retrospective study included adult MS patients in the United States who received natalizumab for 1-5 years. The primary endpoint was the longitudinal change in NeuroTrax GCS from year 1 to 5; additional endpoints included GCS change from year 1 to year 2, 3, or 4 and changes in the 7 individual cognitive domain scores. All mean changes from year 1 to year 2, 3, 4, or 5 were evaluated in patients with data available in both years.
Results: NeuroTrax GCS data were available for 84 patients at year 1; of these, 51, 40, 45, and 42 patients also had data at years 2, 3, 4, and 5, respectively. Mean (SD) GCS was 97.19 (13.95) at year 1, 100.74 (11.833) at year 2, 98.11 (13.177) at year 3, 100.90 (14.139) at year 4, and 98.32 (17.23) at year 5. Mean change from year 1 to year 5 was 2.48 (95% CI: -0.90-5.86; P=0.146; n=42). Mean change in GCS from year 1 to years 2, 3, and 4 were 2.23 (95% CI: 0.21-4.25; P=0.031; n=51), 2.71 (95% CI: 0.07-5.35; P=0.045; n=40), and 1.66 (95% CI: -0.10-3.41; P=0.064; n=45). In the individual cognitive domains, the greatest increases from year 1 to year 5 were observed in the visual, information processing speed, and executive function domains (mean [95% CI] changes from year 1: 7.16 [2.92-11.39], 3.60 [-0.55-7.74], and 3.43 [-0.48-7.34], respectively).
Conclusions: These results provide information on cognitive function during long-term natalizumab treatment (up to 5 years) and extend previous analyses showing clinically significant cognitive function improvement upon natalizumab initiation.
Disclosure: Supported by Biogen.
MG: research support from Biogen, EMD Serono, Novartis, Sanofi-Genzyme, Teva; speaker/consultant fees from Acorda, Amgen, Biogen, EMD-Serono, Medtronic, Novartis, Sanofi-Genzyme, Saol Therapeutics, Teva.
JW: grants from Biogen; grants and personal fees from Sanofi-Genzyme, George Washington University.
MZ: speaker fees from Acorda, Biogen, Genzyme, Teva.
BB: speaker fees from Biogen, Genentech, Genzyme, Teva.
KB: speaker fees from Biogen, Genentech, Teva.
MB: speaker/consultant fees from Biogen, Genentech, Sanofi-Genzyme.
SS, CH, LL: employees of and may hold stock and/or stock options in Biogen.
JS, CL, LF: nothing to disclose.
Abstract: EP1412
Type: Poster Sessions
Abstract Category: Clinical aspects of MS - Clinical assessment tools
Introduction: Cognitive impairment affects many patients with multiple sclerosis (MS). In a previous analysis using NeuroTrax to assess cognitive changes from baseline to 2 years in patients initiating natalizumab, patients demonstrated a significant improvement (mean change from baseline in global cognitive score [GCS], 3.4; P=0.003; N=52), and 32.7% of patients demonstrated clinically significant improvement in GCS (previously defined as an increase from baseline >1 standard deviation [SD]) at year 2.
Objectives: Evaluate changes in cognitive function assessed using NeuroTrax in patients on natalizumab treatment for up to 5 years.
Methods: This retrospective study included adult MS patients in the United States who received natalizumab for 1-5 years. The primary endpoint was the longitudinal change in NeuroTrax GCS from year 1 to 5; additional endpoints included GCS change from year 1 to year 2, 3, or 4 and changes in the 7 individual cognitive domain scores. All mean changes from year 1 to year 2, 3, 4, or 5 were evaluated in patients with data available in both years.
Results: NeuroTrax GCS data were available for 84 patients at year 1; of these, 51, 40, 45, and 42 patients also had data at years 2, 3, 4, and 5, respectively. Mean (SD) GCS was 97.19 (13.95) at year 1, 100.74 (11.833) at year 2, 98.11 (13.177) at year 3, 100.90 (14.139) at year 4, and 98.32 (17.23) at year 5. Mean change from year 1 to year 5 was 2.48 (95% CI: -0.90-5.86; P=0.146; n=42). Mean change in GCS from year 1 to years 2, 3, and 4 were 2.23 (95% CI: 0.21-4.25; P=0.031; n=51), 2.71 (95% CI: 0.07-5.35; P=0.045; n=40), and 1.66 (95% CI: -0.10-3.41; P=0.064; n=45). In the individual cognitive domains, the greatest increases from year 1 to year 5 were observed in the visual, information processing speed, and executive function domains (mean [95% CI] changes from year 1: 7.16 [2.92-11.39], 3.60 [-0.55-7.74], and 3.43 [-0.48-7.34], respectively).
Conclusions: These results provide information on cognitive function during long-term natalizumab treatment (up to 5 years) and extend previous analyses showing clinically significant cognitive function improvement upon natalizumab initiation.
Disclosure: Supported by Biogen.
MG: research support from Biogen, EMD Serono, Novartis, Sanofi-Genzyme, Teva; speaker/consultant fees from Acorda, Amgen, Biogen, EMD-Serono, Medtronic, Novartis, Sanofi-Genzyme, Saol Therapeutics, Teva.
JW: grants from Biogen; grants and personal fees from Sanofi-Genzyme, George Washington University.
MZ: speaker fees from Acorda, Biogen, Genzyme, Teva.
BB: speaker fees from Biogen, Genentech, Genzyme, Teva.
KB: speaker fees from Biogen, Genentech, Teva.
MB: speaker/consultant fees from Biogen, Genentech, Sanofi-Genzyme.
SS, CH, LL: employees of and may hold stock and/or stock options in Biogen.
JS, CL, LF: nothing to disclose.