Abstract

The effect of alemtuzumab on functional systems (FS) scores of the Expanded Disability Status Scale (EDSS) was assessed in CARE-MS II patients over 6 years (y) (CARE-MS II, NCT00548405; extension, NCT00930553). Patients received alemtuzumab (12 mg/day; 2 courses: baseline, 5 days; 12 months later, 3 days), and as-needed alemtuzumab retreatment for relapse/MRI activity in the extension or another disease-modifying therapy per investigator discretion. Assessments: Proportion of patients achieving stable/improved EDSS score (versus core study baseline), FS scores, and 6 month confirmed disability improvement (CDI). In patients who achieved CDI over 6 y (n=126), assessments at 6 months post-CDI onset: EDSS score (<4; ≥4), number of improved FS per patient, and percentage with stable/improved FS scores. At Y6, 77% of patients showed stable/improved EDSS scores; 75%–85% showed stability/improvement in each FS. Through Y6, 43% achieved 6 month CDI. At 6 months post-CDI onset, 96% of CDI patients had an EDSS score <4, and 70% achieved improvements in >1 FS. Improvements were observed in each FS, most frequently Sensory (48%), Pyramidal (44%), and Cerebellar (44%) systems; 21%–25% showed improvements in the Brainstem, Cerebral, Visual, and Bowel/Bladder FS. These findings indicate a broad treatment effect of alemtuzumab on multiple aspects of disability improvements. STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.