Sanofi Genzyme announced positive long-term data on Lemtrada (alemtuzumab) in patients with relapsing remitting multiple sclerosis (RRMS). The findings were presented at the 69th American Academy of Neurology (AAN) Annual Meeting.
In the Phase 3 CARE-MS II study, the majority of patients (76%) treated with Lemtrada did not relapse between their first and second courses of Lemtrada. Those patients who did relapse between courses, however, demonstrated marked improvements in clinical and MRI outcomes after the second course. Over the 6-year study period, the clinical and MRI data in these patients were comparable to those who did not relapse between courses.
The annualized relapse rate (ARR) declined from 1.2 (Year 1) to 0.5 (Year 2) after the second course in patients who relapsed between courses. The ARR decreased further to 0.2 by Year 6. For patients who did not relapse between courses, ARR was sustained at 0.2 (Years 2–5) and decreased to 0.1 by Year 6.
Confirmed disability worsening (CDW) was defined as ≥1-point Expanded Disability Status Scale (EDSS) increase (or ≥1.5 points if baseline EDSS=0). The majority of patients (80%) who relapsed between courses were free of CDW in Year 2 and 60% remained free of CDW by Year 6. For patients who did not relapse between courses, 91% were free of CDW in Year 2 and 75% remained free of CDW by Year 6.
Confirmed disability improvement (CDI) was defined as ≥1-point EDSS decrease from baseline among patients with baseline score ≥2.0 as confirmed over 6 months. Among patients who relapsed between courses, 28% achieved CDI in Year 2; this proportion grew to 34% by Year 6. For patients who did not relapse between courses, 31% achieved CDI in Year 2; this proportion grew to 45% by Year 6.
Additional data on no evidence of disease activity (NEDA), brain volume loss (BVL), and retreatment were also presented. Study authors reported that through 6 years, the most common adverse events seen with Lemtrada were consistent with the CARE-MS I and II full cohorts.
Lemtrada, a monoclonal antibody that targets CD52, is available as a 12mg/1.2mL strength solution in single-use vials.
For more information call (800) 745-4447 or visit Lemtrada.com.