Alemtuzumab Maintains Efficacy on Clinical and MRI Disease Activity Outcomes, Including Slowing of Brain Volume Loss, Over 9 Years in RRMS Patients: CAREMS II Follow-up (TOPAZ Study)

Abstract

Background: In CARE-MS II (NCT00548405), alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved clinical/MRI outcomes vs SC IFNB-1a over 2 years in RRMS patients. Efficacy was maintained in a 4-year extension (NCT00930553), and further follow-up was available in an additional 5-year extension, TOPAZ (NCT02255656).

Objective: To evaluate the efficacy and safety of alemtuzumab in CARE-MS II patients over 9 years.

Methods: At investigator discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (⩾12 months apart; no criteria)/receive other DMT (at any time).

Results: Through Y9, 288/435 (66%) CARE-MS II alemtuzumab-treated patients remained on study,41% received neither additional alemtuzumab/another DMT. At Y9, annualised relapse rate was 0.13. Over 9years, 68% of patients had stable/improved EDSS scores (mean change +0.32), 60% were free of 6-month disability worsening, 49% achieved improvement. In Y9, 72%, 88% and 73% of patients were free of MRI disease activity, new gadolinium-enhancing lesions, and new/enlarging T2 hyperintense lesions, respectively. Median percent cumulative brain volume loss (BVL) was –1.22%; median annual BVL was ⩽0.19% each year (Y3–9). Alemtuzumab had a consistent safety profile, with the incidence of overall adverse events and infections declining through Y9. Efficacy and safety in SC IFNB-‍1a-treated patients from the core study who switched to alemtuzumab in the extension were consistent with those treated with alemtuzumab in the core and extension.

Conclusion: Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 9years in CARE-MS II patients, Safety remained consistent and manageable throughout.