Follow-up data extending out to 8 years suggest that both clinical and MRI outcomes are better with alemtuzumab (Lemtrada) than interferon beta-1a in patients with relapsing-remitting multiple sclerosis.
Ann D. Bass, MD, Medical Director, Comprehensive MS Clinic, the Neurology Center of San Antonio
Ann D. Bass, MD
Long-term follow-up data demonstated that treatment with alemtuzumab (Lemtrada; Sanofi Genzyme) significantly improves both clinical and magnetic resonance imaging (MRI) outcomes compared to treatment with subcutaneous interferon beta-1a (IFNß-1a) in patients with relapsing-remitting multiple sclerosis (MS).1
All told, the therapy’s efficacy was superior to IFN-ß1a through year 2 of treatment and was maintained through 8 years of follow-up. In addition, the observed controllable and consistent safety profile across multiple age groups is indicative of a prolonged benefit with alemtuzumab irrespective of age, the study authors, including Ann D. Bass, MD, medical director, Comprehensive MS Clinic, the Neurology Center of San Antonio, noted. The overall incidence of adverse events (AEs) was balanced across all age groups.
The study data were presented at the 2019 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC), May 28-June 1, in Seattle, Washington.
Alemtuzumab was evaluated over the course of an 8-year period in 811 patients with MS from the pooled CARE-MS I (NCT00530348) and II (NCT00548405) studies, as well as their respective extension studies (NCT00930553 and NCT02255656), dubbed TOPAZ. The therapy was administered in 2 infusions: 12-mg dose per day over the course of 5 days, and then another 12 months later over the course of 3 days. The treatment is a monoclonal antibody that binds to CD52.
Patients were organized into subgroups based on age, with 17% of patients (n = 137) ≤25 years of age, 43% of patients (n = 350) aged >25 to ≤35 years, 29% of patients (n = 238) aged >35 to ≤45 years, and the remaining 11% of patients (n = 86) over the age of 45 years. Through year 8, 73% (n = 590) of alemtuzumab-treated patients remained in the study, and 51% to 55% of patients across all age groups received no additional alemtuzumab.
The annualized relapse rate (ARR) within all age groups was improved significantly through the second year from baseline compared to IFNß-1a, with alemtuzumab-treated patients experiencing rates of 0.22 to 0.24 and IFNß-1a-treated patients experiencing rates of 0.38 to 0.51 (P ≤.05 for all ages). Additionally, ARR was stabilized for these patients in year 8.
Expanded Disability Status Scale (EDSS) scores were improved or stable in 59% to 80% of patients treated with the Sanofi product in the eighth year, while 6-month confirmed disability worsening was observed to occur in fewer patients treated with alemtuzumab (85% to 92% were free of worsening) than IFNß-1a (62% to 88% were free of worsening). The rates of freedom from confirmed disability worsening decreased with age through year 8.
Meanwhile, 20% to 31% of patients treated with alemtuzumab in each age group experienced confirmed disability improvement, compared to only 13% to 25% of those treated with IFNß-1a at year 2. Bass and colleagues noted that unlike the variability observed with rates of disability worsening, the rates of confirmed disability improvement remained relatively stable.
Additionally, the rates of patients who were free of MRI disease activity were much higher with alemtuzumab. In year 2, those rates ranged from 70% to 86% across age groups with the CD52 antibody compared to 42% to 63% with IFNß-1a (P ≤.001 for all ages). At year 8, the rates with alemtuzumab ranged from 61% to 86%.
Bass and colleagues also noted that “median annual brain volume loss was reduced with alemtuzumab vs subcutaneous IFNB-1a within each age group through year 2, and was ≤0.26% annually in years 3-8.”
Alemtuzumab is also being assessed in a study of data from a Risk Evaluation and Mitigation Strategy (REMS) program to explore the impact of the therapy in a real-world MS center population. Thus far, the retrospective chart review has identified patients at a Novant Health Center for Multiple Sclerosis clinic who had an MS diagnosis and were treated with alemtuzumab from August 2016 to the present.2
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1. 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: 2019 CMSC Annual Meeting. May 28-June 1, 2019; Seattle, WA. Abstract DXT05.
2. Kidd J, Tchinda S, Carror M, Schuette N. Evaluation of the Safety and Efficacy of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis. Presented at: 2019 CMSC Annual Meeting. May 28-June 1, 2019; Seattle, WA. Abstract DXT06.