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.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: R.A. and D.C. have nothing to disclose. D.P.B. is currently employed by Sanofi on a contract basis (RWE/COA/PRO group). J.D.G. was an employee of Sanofi at the time of the analysis and is currently employed at Bristol-Myers Squibb, Lawrence Township, NJ, USA. D.H.M. was an employee of Sanofi at the time of the analysis and is currently employed at Cerevance, Inc., Boston, MA, USA, and reports personal fees from Sanofi outside the submitted work; in addition, he has patents US9664688 and US009498528 issued. M.M. and N.D. are employees of Sanofi.

Figures

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.