Alemtuzumab Improves Clinical and Radiological Outcomes in Patients with Relapsing-remitting Multiple Sclerosis Over 8 Years: Care-MS I Follow-up (topaz Study)

Abstract

Background: In the 2-year (y) CARE-MS I trial (nct00530348), alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved clinical and MRI outcomes versus sc IFNB-1a in treatment-naive patients with active RRMS. In a 4-y extension (nct00930553), patients could receive additional alemtuzumab (12 mg/day; 3 days; ≥12 months apart) as needed for disease activity or receive other disease-modifying therapy (DMT; investigator's discretion). Efficacy was maintained in the extension, with 63% of patients receiving no additional alemtuzumab or other DMTS through y6. Following the initial 4-y extension, patients could continue in TOPAZ (nct02255656), an additional 5-y extension. Here, we report 8-y efficacy and safety of alemtuzumab in CARE-MS I patients.