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Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis.
Mult Scler. 2020 07; 26(8):955-963.MS

Abstract

BACKGROUND

In CARE-MS II (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis; NCT00548405), alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved health-related quality of life (HRQL) outcomes versus subcutaneous interferon beta-1a (SC IFNB-1a) in relapsing-remitting multiple sclerosis (RRMS) patients over 2 years. Patients completing CARE-MS II could enter a 4-year extension study (NCT00930553).

OBJECTIVE

The aim of this study is to assess 6-year HRQL outcomes in alemtuzumab-treated CARE-MS II patients, including those with highly active disease (HAD).

METHODS

During extension, patients could receive additional alemtuzumab for clinical/magnetic resonance imaging (MRI) activity or other disease-modifying therapies per investigator's discretion. Assessments include Functional Assessment of Multiple Sclerosis (FAMS), 36-Item Short-Form Health Survey (SF-36), and EQ-5D visual analog scale (EQ-VAS).

RESULTS

Alemtuzumab-treated patients improved or stabilized all HRQL measures over 6 years with significant improvements from baseline at all time points on EQ-VAS and for up to 5 years on FAMS, SF-36 MCS, and SF-36 PCS. Alemtuzumab-treated patients with HAD showed significant improvements versus baseline at Year 2 on all HRQL measures, and significant improvements versus SC IFNB-1a on SF-36 PCS and EQ-VAS; however, the improvements did not reach the threshold for clinical relevance.

CONCLUSION

Alemtuzumab-treated CARE-MS II patients improved or stabilized HRQL versus baseline over 6 years. This is the first study to show long-term HRQL benefits in patients with HAD.

Authors+Show Affiliations

Department of Neurology, Hospital Universitario Quirónsalud, Madrid, Spain.Contractor to Sanofi Genzyme, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA; Bristol-Myers Squibb, Lawrence Township, NJ, USA.Sanofi, Cambridge, MA, USA; Cerevance, Inc., Boston, MA, USA.Sanofi, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA.Department of Medical Social Sciences, Center for Patient-Centered Outcomes, Institute for Public Health and Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31144568

Citation

Arroyo, Rafael, et al. "Impact of Alemtuzumab On Health-related Quality of Life Over 6 Years in CARE-MS II Trial Extension Patients With Relapsing-remitting Multiple Sclerosis." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 26, no. 8, 2020, pp. 955-963.
Arroyo R, Bury DP, Guo JD, et al. Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Mult Scler. 2020;26(8):955-963.
Arroyo, R., Bury, D. P., Guo, J. D., Margolin, D. H., Melanson, M., Daizadeh, N., & Cella, D. (2020). Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. Multiple Sclerosis (Houndmills, Basingstoke, England), 26(8), 955-963. https://doi.org/10.1177/1352458519849796
Arroyo R, et al. Impact of Alemtuzumab On Health-related Quality of Life Over 6 Years in CARE-MS II Trial Extension Patients With Relapsing-remitting Multiple Sclerosis. Mult Scler. 2020;26(8):955-963. PubMed PMID: 31144568.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of alemtuzumab on health-related quality of life over 6 years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis. AU - Arroyo,Rafael, AU - Bury,Denise P, AU - Guo,Jennifer D, AU - Margolin,David H, AU - Melanson,Maria, AU - Daizadeh,Nadia, AU - Cella,David, Y1 - 2019/05/30/ PY - 2019/5/31/pubmed PY - 2019/5/31/medline PY - 2019/5/31/entrez KW - Alemtuzumab KW - EQ-VAS KW - FAMS KW - SF-36 KW - health-related quality of life KW - patient-reported outcomes KW - relapsing-remitting multiple sclerosis SP - 955 EP - 963 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult Scler VL - 26 IS - 8 N2 - BACKGROUND: In CARE-MS II (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis; NCT00548405), alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved health-related quality of life (HRQL) outcomes versus subcutaneous interferon beta-1a (SC IFNB-1a) in relapsing-remitting multiple sclerosis (RRMS) patients over 2 years. Patients completing CARE-MS II could enter a 4-year extension study (NCT00930553). OBJECTIVE: The aim of this study is to assess 6-year HRQL outcomes in alemtuzumab-treated CARE-MS II patients, including those with highly active disease (HAD). METHODS: During extension, patients could receive additional alemtuzumab for clinical/magnetic resonance imaging (MRI) activity or other disease-modifying therapies per investigator's discretion. Assessments include Functional Assessment of Multiple Sclerosis (FAMS), 36-Item Short-Form Health Survey (SF-36), and EQ-5D visual analog scale (EQ-VAS). RESULTS: Alemtuzumab-treated patients improved or stabilized all HRQL measures over 6 years with significant improvements from baseline at all time points on EQ-VAS and for up to 5 years on FAMS, SF-36 MCS, and SF-36 PCS. Alemtuzumab-treated patients with HAD showed significant improvements versus baseline at Year 2 on all HRQL measures, and significant improvements versus SC IFNB-1a on SF-36 PCS and EQ-VAS; however, the improvements did not reach the threshold for clinical relevance. CONCLUSION: Alemtuzumab-treated CARE-MS II patients improved or stabilized HRQL versus baseline over 6 years. This is the first study to show long-term HRQL benefits in patients with HAD. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/31144568/Impact_of_alemtuzumab_on_health_related_quality_of_life_over_6_years_in_CARE_MS_II_trial_extension_patients_with_relapsing_remitting_multiple_sclerosis_ L2 - https://journals.sagepub.com/doi/10.1177/1352458519849796?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -
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