Impact of alemtuzumab on health-related quality of life over 6?years in CARE-MS II trial extension patients with relapsing-remitting multiple sclerosis.

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.

SUBMITTER: Arroyo R 

PROVIDER: S-EPMC7350196 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature