Contributions
Abstract: EP1798
Type: ePoster
Abstract Category: Therapy - disease modifying - 32 Others
Background: With over 10 years of post-marketing experience, natalizumab (NTZ) has well-established efficacy and long-term safety in relapsing-remitting multiple sclerosis patients. In addition to demonstrating the effectiveness of NTZ in significantly delaying and improving disability, clinical trials and real-world observational studies have shown significant improvement in patient-reported outcomes (PROs). These measures complement clinician-reported data and provide data on treatment impact from the patient perspective.
Objectives: To identify, synthesize, and summarise available PRO data for multiple sclerosis (MS) patients treated with NTZ.
Methods: A systematic search of the peer-reviewed Embase, Medline, and Cochrane databases (January 2006-April 2017), and conference proceedings (2015, 2016), was performed. Selection of eligible studies, data extraction, and quality assessment were undertaken independently by 2 researchers. Selection criteria included studies of NTZ-treated adults with MS that reported on any PRO outcome.
Results: Thirty-seven publications were identified, which included sample sizes ranging from 9 - 2,822 participants. The most frequently assessed domains included mental/psychosocial (16 studies), fatigue (16 studies), physical functioning (15 studies), depression (14 studies) and overall health-related quality of life (HRQoL) (9 studies). The most frequently used PROs included the MS Impact Scale (7 studies), Beck Depression Inventory (7 studies), Fatigue Scale for Motor and Cognitive Functions (6 studies) and Fatigue Severity Scale (6 studies). Changes in PRO scores were primarily examined over 6 months to 5 years. NTZ generally improved HRQoL, physical functioning, cognition, depression, work productivity, bladder function and fatigue as compared to baseline scores. Eleven studies presented results comparing NTZ-treated patients to those being treated with other disease-modifying agents (DMTs), primarily interferon and fingolimod. The majority of these comparative studies favoured NTZ over other DMTs in the assessed domains.
Conclusion: Over the last 10 years, NTZ has demonstrated an improvement in PROs in most major domains of physical, emotional and symptom assessment. The analysis of these relevant PROs will help enable more informed health care decision-making beyond the traditional clinical endpoints.
Disclosure: K Nair received personal compensation for consulting from Astellas and grant funding from Biogen, Genentech, Novartis and Gilead. T Vollmer received honoraria for serving on scientific advisory boards, lectures and for consulting services from AbbVie Inc, Aclimed, American Academy of Neurology, CB Partners, Capmaels and Rasford, Celestial Intas Pharmaceuticals Ltd, Compass Learning, Genentech/Roche, Genzyme/Sanofi, Goodwin Procter LLP, IMS Consulting Group, Medscape, Novartis Pharmaceuticals, Oxford Pharmagenesis, Patient Centered Outcomes Research Institute, Sommer Consulting, and Teva Neuroscience as well as research support from Genzyme, Teva Neuroscience, NIH/NINDS, Rocky Mountain MS Center, EMD Serono, Biogen Idec, Ono Pharmaceuticals, Medimmune and TG Therapeutics Inc. K Lipman is an employee of ICON, which was commissioned to conduct the research. E Flood is an employee of ICON, which was commissioned to conduct the research. C Davey is an employee of ICON, which was commissioned to conduct the research. W Huang is an employee of University of California San Francisco and is conducting a fellowship at Biogen. M Jhaveri is an employee of, and holds stock/stock options in Biogen. L Lee is an employee of, and holds stock/stock options in Biogen. S Licata is an employee of, and holds stock/stock options in Biogen. S Naoshy is an employee of, and holds stock/stock options in Biogen.
Abstract: EP1798
Type: ePoster
Abstract Category: Therapy - disease modifying - 32 Others
Background: With over 10 years of post-marketing experience, natalizumab (NTZ) has well-established efficacy and long-term safety in relapsing-remitting multiple sclerosis patients. In addition to demonstrating the effectiveness of NTZ in significantly delaying and improving disability, clinical trials and real-world observational studies have shown significant improvement in patient-reported outcomes (PROs). These measures complement clinician-reported data and provide data on treatment impact from the patient perspective.
Objectives: To identify, synthesize, and summarise available PRO data for multiple sclerosis (MS) patients treated with NTZ.
Methods: A systematic search of the peer-reviewed Embase, Medline, and Cochrane databases (January 2006-April 2017), and conference proceedings (2015, 2016), was performed. Selection of eligible studies, data extraction, and quality assessment were undertaken independently by 2 researchers. Selection criteria included studies of NTZ-treated adults with MS that reported on any PRO outcome.
Results: Thirty-seven publications were identified, which included sample sizes ranging from 9 - 2,822 participants. The most frequently assessed domains included mental/psychosocial (16 studies), fatigue (16 studies), physical functioning (15 studies), depression (14 studies) and overall health-related quality of life (HRQoL) (9 studies). The most frequently used PROs included the MS Impact Scale (7 studies), Beck Depression Inventory (7 studies), Fatigue Scale for Motor and Cognitive Functions (6 studies) and Fatigue Severity Scale (6 studies). Changes in PRO scores were primarily examined over 6 months to 5 years. NTZ generally improved HRQoL, physical functioning, cognition, depression, work productivity, bladder function and fatigue as compared to baseline scores. Eleven studies presented results comparing NTZ-treated patients to those being treated with other disease-modifying agents (DMTs), primarily interferon and fingolimod. The majority of these comparative studies favoured NTZ over other DMTs in the assessed domains.
Conclusion: Over the last 10 years, NTZ has demonstrated an improvement in PROs in most major domains of physical, emotional and symptom assessment. The analysis of these relevant PROs will help enable more informed health care decision-making beyond the traditional clinical endpoints.
Disclosure: K Nair received personal compensation for consulting from Astellas and grant funding from Biogen, Genentech, Novartis and Gilead. T Vollmer received honoraria for serving on scientific advisory boards, lectures and for consulting services from AbbVie Inc, Aclimed, American Academy of Neurology, CB Partners, Capmaels and Rasford, Celestial Intas Pharmaceuticals Ltd, Compass Learning, Genentech/Roche, Genzyme/Sanofi, Goodwin Procter LLP, IMS Consulting Group, Medscape, Novartis Pharmaceuticals, Oxford Pharmagenesis, Patient Centered Outcomes Research Institute, Sommer Consulting, and Teva Neuroscience as well as research support from Genzyme, Teva Neuroscience, NIH/NINDS, Rocky Mountain MS Center, EMD Serono, Biogen Idec, Ono Pharmaceuticals, Medimmune and TG Therapeutics Inc. K Lipman is an employee of ICON, which was commissioned to conduct the research. E Flood is an employee of ICON, which was commissioned to conduct the research. C Davey is an employee of ICON, which was commissioned to conduct the research. W Huang is an employee of University of California San Francisco and is conducting a fellowship at Biogen. M Jhaveri is an employee of, and holds stock/stock options in Biogen. L Lee is an employee of, and holds stock/stock options in Biogen. S Licata is an employee of, and holds stock/stock options in Biogen. S Naoshy is an employee of, and holds stock/stock options in Biogen.