Switching to natalizumab is associated with improvements in cognitive function as measured by NeuroTrax
ECTRIMS Online Library. Gudesblatt M. 10/27/17; 200909; P1254
Mark Gudesblatt
Mark Gudesblatt
Contributions
Abstract

Abstract: P1254

Type: Poster

Abstract Category: Therapy - symptomatic - 33 Treatment of specific symptoms

Background: Cognitive impairment affects the majority of MS patients and is not commonly recognized or monitored. NeuroTrax (NT) is a computerized cognitive assessment administered in an office setting in ~45 minutes. NT provides an objective cognitive profile measure with a global cognitive score (GCS) and 7 individual domain scores (memory, executive function, attention, information processing speed, motor function, verbal function, and visual-spatial processing). A historical publication has described the use of NT in a MS cohort (N=1500) with ≤30 years of disease duration (Achiron, et al. PLoS One 2013;8:e71058). This cohort exhibited poorer cognitive performance than healthy subjects, especially in the executive function and information processing speed domains.
Objective: To assess cognitive function as measured by NT in MS patients treated with natalizumab for ≥2 years.
Methods: This retrospective observational study included US patients aged 18-70 years with MS who had ≥2 cognitive test dates >10 months apart in the course of routine clinical care while on 300 mg intravenous natalizumab every 4 weeks for ≥2 years. Chart information was retrospectively reviewed to examine NT data assessed at baseline and yearly thereafter. This study measured change in GCS and the 7 individual domain scores from baseline to post >24 infusions of natalizumab. Change from baseline in global and individual domain scores at each year was analyzed using a generalized estimating equation model adjusted for baseline Expanded Disability Status Scale (EDSS) score and age.
Results: In the intent-to-treat population at baseline (N=52), 22 patients (42%) had disease duration of 0-5 years and 30 (58%) had disease duration ≥6 years. The mean (standard deviation [SD]) baseline EDSS score was 2.17 (1.74). Prior to initiating natalizumab, 12 patients (23%) were treatment naive and 40 (77%) were on another disease-modifying treatment (DMT). GCS score improved significantly from baseline (median [range]: 97.9 [63.2-115.4]; mean [SD]: 95.5 [12.9]) to year 2 (median [range]: 101.2 [61.4-116.3]; mean [SD]: 98.9 [13.2]; P=0.0029). Improvement was observed in all 7 cognitive domains from baseline through year 2.
Conclusions: Whether patients were treatment naive or previously treated with other DMTs, natalizumab significantly improved cognitive function, measured by NT global scores, over 2 years of treatment. Cognitive impairment can be reduced in MS patients with high-efficacy DMT use.
Disclosure: Supported by Biogen.
MG: Research support from Biogen, EMD Serono, Novartis, Sanofi-Genzyme, Teva; speaker fees/consultant for: Acorda, Amgen, Biogen, EMD-Serono, Medtronic, Novartis, Sanofi-Genzyme, Saol Therapeutics, Teva.
KW: Nothing to disclose.
MZ: Speaker fees from Accorda, Biogen, Genzyme, and Teva.
BB: Speaker fees from Biogen, Genotech, Genzyme, and Teva.
LF: Nothing to disclose.
JW: Grants from Biogen; grants and personal fees from Sanofi Genzyme and George Washington University.
KB: Speaker fees from Biogen, Genentech, and Teva.
MB: Nothing to disclose.
QD, CH, JW, LL: employees of and hold stock and/or stock options in Biogen.

Abstract: P1254

Type: Poster

Abstract Category: Therapy - symptomatic - 33 Treatment of specific symptoms

Background: Cognitive impairment affects the majority of MS patients and is not commonly recognized or monitored. NeuroTrax (NT) is a computerized cognitive assessment administered in an office setting in ~45 minutes. NT provides an objective cognitive profile measure with a global cognitive score (GCS) and 7 individual domain scores (memory, executive function, attention, information processing speed, motor function, verbal function, and visual-spatial processing). A historical publication has described the use of NT in a MS cohort (N=1500) with ≤30 years of disease duration (Achiron, et al. PLoS One 2013;8:e71058). This cohort exhibited poorer cognitive performance than healthy subjects, especially in the executive function and information processing speed domains.
Objective: To assess cognitive function as measured by NT in MS patients treated with natalizumab for ≥2 years.
Methods: This retrospective observational study included US patients aged 18-70 years with MS who had ≥2 cognitive test dates >10 months apart in the course of routine clinical care while on 300 mg intravenous natalizumab every 4 weeks for ≥2 years. Chart information was retrospectively reviewed to examine NT data assessed at baseline and yearly thereafter. This study measured change in GCS and the 7 individual domain scores from baseline to post >24 infusions of natalizumab. Change from baseline in global and individual domain scores at each year was analyzed using a generalized estimating equation model adjusted for baseline Expanded Disability Status Scale (EDSS) score and age.
Results: In the intent-to-treat population at baseline (N=52), 22 patients (42%) had disease duration of 0-5 years and 30 (58%) had disease duration ≥6 years. The mean (standard deviation [SD]) baseline EDSS score was 2.17 (1.74). Prior to initiating natalizumab, 12 patients (23%) were treatment naive and 40 (77%) were on another disease-modifying treatment (DMT). GCS score improved significantly from baseline (median [range]: 97.9 [63.2-115.4]; mean [SD]: 95.5 [12.9]) to year 2 (median [range]: 101.2 [61.4-116.3]; mean [SD]: 98.9 [13.2]; P=0.0029). Improvement was observed in all 7 cognitive domains from baseline through year 2.
Conclusions: Whether patients were treatment naive or previously treated with other DMTs, natalizumab significantly improved cognitive function, measured by NT global scores, over 2 years of treatment. Cognitive impairment can be reduced in MS patients with high-efficacy DMT use.
Disclosure: Supported by Biogen.
MG: Research support from Biogen, EMD Serono, Novartis, Sanofi-Genzyme, Teva; speaker fees/consultant for: Acorda, Amgen, Biogen, EMD-Serono, Medtronic, Novartis, Sanofi-Genzyme, Saol Therapeutics, Teva.
KW: Nothing to disclose.
MZ: Speaker fees from Accorda, Biogen, Genzyme, and Teva.
BB: Speaker fees from Biogen, Genotech, Genzyme, and Teva.
LF: Nothing to disclose.
JW: Grants from Biogen; grants and personal fees from Sanofi Genzyme and George Washington University.
KB: Speaker fees from Biogen, Genentech, and Teva.
MB: Nothing to disclose.
QD, CH, JW, LL: employees of and hold stock and/or stock options in Biogen.

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