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THUR 193 Alemtuzumab improves disability across functional systems
  1. Sharrack Basil1,
  2. Hunter Samuel2,
  3. Aburashed Rany3,
  4. Alroughani Raed4,
  5. Dive Dominique5,
  6. Izquierdo Giullermo6,
  7. Kim Ho Jin7,
  8. Lycke Jan8,
  9. Macdonell Richard9,
  10. et al,
  11. on behalf of the CARE-MS II and CAMMS03409 Investigators
  1. 1Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
  2. 2Advanced Neurosciences Institute, Franklin, TN, USA
  3. 3Institute for Neurosciences and Multiple Sclerosis, Owosso, MI, USA
  4. 4Amiri Hospital, Sharq, Kuwait
  5. 5University Hospital Centre of Liège, Liège, Belgium
  6. 6Virgen Macarena University Hospital, Seville, Spain
  7. 7Research Institute and Hospital of National Cancer Center, Goyang, Korea
  8. 8Institution of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg
  9. 9Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, Australia


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.

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