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 is efficacious and safe in the long term to treat high-risk patients with multiple sclerosis (MS) who are of African descent, according to research presented at the 2019 Consortium of Multiple Sclerosis Centers Annual Meeting, held May 28 to June 1, 2019, in Seattle, Washington.
The investigators of this study sought to evaluate the long-term efficacy and safety of alemtuzumab to treat patients of African descent who have relapsing-remitting MS. The study included 43 patients who participated in a 2-year core study and were randomly assigned to receive alemtuzumab or subcutaneous interferon beta-1a treatments; 29 patients remained in the 4-year extension study and received additional alemtuzumab or disease-modifying therapy ; 24 patients continued for another extension period of 2 years or longer.
The investigators pooled outcomes for patients who completed over 6 years in the study, including those who received core alemtuzumab treatment and those who received alemtuzumab in the extension only. After 2 years, the annualized relapse rate for the subcutaneous interferon beta-1a group was 0.42 compared with 0.1 in the pooled alemtuzumab group; at 6 years, the pooled relapse rate remained low at 0.15, and at 8 years, it was 0.30.
Compared with the core study baseline scores, 63% of patients had stable or improved Expanded Disability Status Scale scores at year 6; 47% reported 6-month confirmed disability improvement, and 72% were free of 6-month confirmed disability worsening. At 8 years, 60% of patients had stable/improved Expanded Disability Status Scale scores; 55% reported 6-month confirmed disability improvement, and 54% were free of 6-month confirmed disability worsening. On MRI at year 6, 77% of patients were free of Gd-enhancing lesions, and 61% were free of new/enlarging T2 lesions; at year 8, all patients were free of Gd-enhancing lesions, and 53% were free of new/enlarging T2 lesions.
The investigators concluded that through 6 or 8 years post-alemtuzumab, patients with MS of African descent maintained clinical and MRI efficacy. Safety outcomes were consistent with the core study results.
This study was sponsored by Sanofi, Bayer Health Care Pharmaceuticals.
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Okai A, Amezcua L, Berkovich R, et al. Efficacy and safety of alemtuzumab in patients of African descent in CARE-MS I and II: 8-year follow-up (TOPAZ study). Presented at: 2019 Consortium of Multiple Sclerosis Centers Annual Meeting; May 28 to June 1, 2019; Seattle, WA. Abstract DXM01.