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.

Keywords: Alemtuzumab; EQ-VAS; FAMS; SF-36; health-related quality of life; patient-reported outcomes; relapsing-remitting multiple sclerosis.

Figure 1.

Change from baseline in HRQL over 6 years in RRMS patients from CARE-MS II. Change from core study baseline in (a) FAMS total, (b) SF-36 MCS, (c) SF-36 PCS, and (d) EQ-VAS scores. FAMS and EQ-VAS were administered at baseline (Month 0), every 6 months thereafter up to Year 3, and every 12 months from Years 3 to 6. The SF-36 was administered at baseline (Month 0), every 12 months thereafter up to Year 2, every 6 months from Years 2 to 3, and every 12 months from Years 3 to 6. CARE-MS: Comparison of Alemtuzumab and Rebif^® Efficacy in Multiple Sclerosis; CI: confidence interval; EQ-VAS: European Quality of Life-5 Dimensions-3-level visual analog scale; FAMS: Functional Assessment of Multiple Sclerosis, version 4; HRQL: health-related quality of life; MCS: mental component summary; PCS: physical component summary; RRMS: relapsing-remitting multiple sclerosis; SC IFNB-1a: subcutaneous interferon beta-1a; SD: standard deviation; SF-36: 36-Item Short-Form Survey, version 2. ^aData are least-squares means (95% CIs). ^bAlemtuzumab baseline mean (SD) scores: FAMS total score, 119.1 (31.6); SF-36 MCS score, 44.9 (11.8); SF-36 PCS score, 42.7 (10.2); EQ-VAS score, 70.1 (19.1). *p < 0.05 versus baseline (alemtuzumab-treated patients). ^†p < 0.05 versus SC IFNB-1a.

Figure 2.

Change from baseline in HRQL over 6 years in the HAD subpopulation of RRMS patients from CARE-MS II. Change from core study baseline in (a) FAMS total, (b) SF-36 MCS, (c) SF-36 PCS, and (d) EQ-VAS scores. FAMS and EQ-VAS were administered at baseline (Month 0), every 6 months thereafter up to Year 3, and every 12 months from Years 3 to 6. The SF-36 was administered at baseline (Month 0), every 12 months thereafter up to Year 2, every 6 months from Years 2 to 3, and every 12 months from Years 3 to 6. CARE-MS: Comparison of Alemtuzumab and Rebif^® Efficacy in Multiple Sclerosis; CI: confidence interval; EQ-VAS: European Quality of Life-5 Dimensions-3-level visual analog scale; FAMS: Functional Assessment of Multiple Sclerosis, version 4; HAD: highly active disease; HRQL: health-related quality of life; MCS: mental component summary; PCS: physical component summary; RRMS: relapsing-remitting multiple sclerosis; SC IFNB-1a: subcutaneous interferon beta-1a; SD: standard deviation; SF-36: 36-Item Short-Form Survey, version 2. ^aData are least-squares means (95% CIs). ^bAlemtuzumab baseline mean (SD) score: FAMS total score, 122.0 (29.1); SF-36 MCS score, 45.0 (11.6); SF-36 PCS score, 43.3 (9.7); and EQ-VAS score, 72.0 (17.4). *p < 0.05 versus baseline. ^†p < 0.05 versus SC IFNB-1a.