DX65
Durable Improvements in MRI Disease Activity and Brain Volume Loss with Alemtuzumab in RRMS Patients: 7-Year Follow-up of Care-MS II
Objectives: To evaluate MRI lesion outcomes and BVL over 7 y (2 y of core study plus 4 y of extension and Y1 of TOPAZ) in RRMS patients initially randomized to alemtuzumab in CARE-MS II.
Methods: In TOPAZ, patients can receive alemtuzumab (12 mg/day on 3 consecutive days) retreatment ≥12 months after the most recent course or other DMTs at any time, both per investigator’s discretion. Assessments: Annual MRI for disease activity (scored as new gadolinium [Gd]-enhancing lesions; new/enlarging T2 lesions), new T1 hypointense lesions, and BVL (derived by relative change in brain parenchymal fraction [BPF]).
Results: Of the 336 patients who entered TOPAZ, 317 (94%) completed Y1 (Y7 after initiating alemtuzumab). 47% received neither alemtuzumab retreatment nor another DMT, and 88% did not receive another DMT after the initial 2 courses. At Y7, patients were free of MRI disease activity (67%), new Gd-enhancing lesions (90%), new/enlarging T2 lesions (67%), and new T1 hypointense lesions (88%). Median change from baseline in BPF was –0.48%, –0.62%, –0.69%, –0.88%, –0.86%, –0.96%, and –0.94% in Y1–7, respectively. Median annual BPF change was significantly reduced with alemtuzumab versus SC IFNB-1a over 2 y (Y1: –0.48% vs –0.54%, Y2: –0.62% vs –0.81%; P=0.0121 vs SC IFNB-1a in Y2), remaining low in alemtuzumab-treated patients in Y3–7 (Y3: –0.10%, Y4: –0.19%, Y5: –0.07%, Y6: –0.10%, Y7: –0.14%).
Conclusions: Alemtuzumab durably reduced MRI disease activity and slowed BVL over 7 y in patients who were initially randomized to alemtuzumab in CARE-MS II, despite 47% receiving no additional treatment after the initial 2 courses. Alemtuzumab provides a unique treatment approach for RRMS patients, offering durable efficacy without continuous treatment.
Study Support: Sanofi and Bayer HealthCare Pharmaceuticals.