DX66
Active RRMS Patients Show Disability Improvements in Each Functional System Following Treatment with Alemtuzumab: Results from Care-MS II Extension
Objectives: To assess the effect of alemtuzumab on disability improvement at the level of functional systems (FS) scores of the Expanded Disability Status Scale (EDSS) in CARE-MS II patients over 6 years.
Methods: Assessments: percentage of patients achieving stable/improved EDSS score (≤0.5-point change/≥1.0-point decrease from baseline mean [SD] EDSS score, 2.7 [1.2]), stable/improved FS score (0-point change/≥1.0-point decrease from baseline FS score), and 6-month CDI (≥1.0-point EDSS decrease confirmed over 6 months in patients with baseline score ≥2.0). In patients who achieved 6-month CDI over 6 years (n=297), assessments included percentage with EDSS score (<4; ≥4), number of improved FS per patient, and percentage with stable/improved FS scores.
Results: Of the 393 patients who entered the extension, 338 (86%) remained on study through Year 6. At Year 6, 77% of the patients showed stable/improved EDSS scores versus baseline, and 75%–85% showed stability/improvement across all FS. Through Year 6, 43% achieved 6-month CDI; 96% of these patients had an EDSS score <4. The majority of patients (>70%) achieved improvements in >1 FS (improvement in 2 FS: 29.4%; 3 FS: 24.6%; and ≥4 FS: 16.7%). Improvements were observed in each FS; the percentage of patients showing improvements was the highest in the sensory (48%), pyramidal (44%), and cerebellar (44%) FS; 21%–25% showed improvements in the brainstem, cerebral, visual, and bowel/bladder FS.
Conclusions: At Year 6, the majority (75%–85%) of alemtuzumab-treated patients from CARE-MS II had improved/stable scores across all FS of the EDSS. The robustness of these results is underscored by the high retention rate observed in the extension (86% of patients remained on study through Year 6). Improvements were seen for each of the FS in patients who achieved 6-month CDI, with more than 70% showing improvements in >1 FS, indicating a broad treatment effect with alemtuzumab in improving multiple aspects of disability.
Study Support: Sanofi and Bayer Healthcare Pharmaceuticals