DX06
Efficacy of a Fourth Alemtuzumab Course in RRMS Patients with Disease Activity after Three Prior Courses: Analysis of Care-MS II
Objectives: To evaluate efficacy of a fourth course of alemtuzumab (Course [C] 4) in CARE-MS II patients who received ≥4 courses due to relapse and/or MRI activity.
Methods: Assessments 12 months before and up to 3 years after alemtuzumab C4 were compared: annualized relapse rate (ARR); improved/stable Expanded Disability Status Scale (EDSS) score (versus core study baseline); 6-month confirmed disability improvement (CDI). Included patients (N=43 [11%]) received ≥4 courses within 60 months of baseline to allow for 1 year of follow-up after C4, and received no other DMT. Data for those who received a fifth course (C5) were censored at the time of C5 administration onward.
Results: ARR decreased following treatment with C4, from 0.75 (12 months before C4) to 0.19 (12 months after C4; rate ratio [95% CI], 0.25 [0.13–0.49]; P<0.0001), remaining low (0.23) at Year 3 after C4. EDSS scores versus core study baseline were stable/improved in 67.5% of patients 12 months after C4, compared with 53.5% of patients at the time of C4 administration. The percentage with CDI increased from 10.0% (12 months before C4) to 26.7% (12 months after C4). Outcomes were similar among the subgroup of patients who received exactly 4 courses, as in those who received ≥4 courses.
Conclusions: A fourth course reduced relapses and stabilized/improved disability in CARE-MS II patients who received ≥4 courses due to disease activity after 3 prior alemtuzumab courses.
Study Support: Sanofi and Bayer HealthCare Pharmaceuticals.