Alemtuzumab Improves Clinical, MRI Outcomes in MS Across all Age Groups

brain scan, MS
brain scan, MS
Investigators sought to determine the 8-year safety and efficacy of alemtuzumab in patients with relapsing-remitting multiple sclerosis from the CARE-MS I and II studies.

The following article is part of conference coverage from the 2019 Annual Meeting of the Consortium of Multiple Sclerosis Centers , in Seattle, Washington. Neurology Advisor‘s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from CMSC 2019.

SEATTLE — Alemtuzumab improved clinical and magnetic resonance imaging (MRI) outcomes compared with subcutaneous interferon beta-1a (SC IFNB-1a) through year 2 in all age groups with relapsing-remitting multiple sclerosis, according to research presented at the Consortium of Multiple Sclerosis Centers’ Annual Meeting, held May 28 to June 1, in Seattle, Washington. Efficacy persisted through year 8, with a consistent and manageable safety profile across all of the age groups.

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The CARE-MS I and II studies assessed the efficacy and safety of alemtuzumab (12 mg per day for 5 days at baseline, then 12 mg per day for 3 days 12 months later) vs SC IFNB-1a and continued assessment with 2 consecutive extensions through year 8. The studies evaluated the safety and efficacy of alemtuzumab in a pool of CARE-MS patients stratified by age (N=811). Participants were grouped at baseline as follows: 137 patients aged ≤25 (17%), 350 patients aged >25 and ≤35 (43%), 238 patients >35 and ≤45 (29%), and 86 patients >45 (11%).

Of the 811 alemtuzumab-treated patients, 73% (n=590) remained through year 8, and 51% to 55% of patients across all age groups received no additional alemtuzumab. Annualized relapse rate for each age group significantly improved with alemtuzumab vs SC IFNB-1a through year 2 (0.22-0.24 vs 0.38-0.51; all P ≤.05), and annualized relapse rate stabilized through year 8. In year 8, 59% to 80% of alemtuzumab-treated patients had Expanded Disability Status Scale scores that were improved or stable when compared with baseline. At year 2, more patients treated with alemtuzumab vs SC IFNB-1a were free of 6-month confirmed disability worsening (85%-92% vs 62%-88%) and achieved 6-month confirmed disability improvement (20%-31% vs 13%-25%) within each age group. Alemtuzumab-treated patients showed decreased confirmed disability worsening rates through year 8, while rates of confirmed disability improvement showed less variability. The percentages of participants showing no MRI disease activity within each age group were significantly higher with alemtuzumab compared with SC IFNB-1a in year 2 (70%-86% vs 42%-63%; all P ≤.001), reaching 61%-86% with alemtuzumab at year 8. Within each age group through year 2, median annual brain volume loss was reduced with alemtuzumab compared with SC IFNB-1a, reaching ≤0.26% annually in year 3 to year 8. Overall prevalence of adverse events were similar across all age groups.

Study investigators conclude, “Alemtuzumab significantly improved clinical and MRI outcomes vs SC IFNB-1a through [year 2] in CARE-MS patients across all age groups tested. Efficacy was maintained through [year-8], with a manageable and consistent safety profile across age groups, suggesting prolonged benefit with alemtuzumab irrespective of age.”

This study was supported by Sanofi and Bayer HealthCare Pharmaceuticals. Several authors report connection with pharmaceutical companies. Please see the reference for a complete list of disclosures.

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Bass AD, Arroyo R, Boster A, et al. Alemtuzumab improves clinical and magnetic resonance imaging outcomes in relapsing-remitting multiple sclerosis patients across age groups: CARE-MS I and II 8-year follow-up. Presented at: The Consortium of Multiple Sclerosis Centers Annual Meeting; May 28-June 1, 2019; Seattle, WA. Abstract DXT05.