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  1. Gavin Giovannoni1,
  2. Regina Berkovich2,
  3. Oscar Fernandez3,
  4. Heinz Wiendl4,
  5. David Margolin5,
  6. Karthinathan Thangavelu5,
  7. Christopher LaGanke6,
  8. on behalf of the CARE-MS I and CARE-MS II Investigators1
  1. 1 Queen Mary University of London, Barts and The London School of Medicine
  2. 2 Keck School of Medicine, University of Southern California, Los Angeles
  3. 3 Fundacion IMABIS, Hospital Universitario Carlos Haya, Spain
  4. 4 University of Münster, Germany
  5. 5 Sanofi Genzyme
  6. 6 North Central Neurology Associates, Cullman, USA


In patients with relapsing-remitting MS (RRMS) and an inadequate response (≥1 relapse) to prior therapy, alemtuzumab improved Expanded Disability Status Scale (EDSS) functional systems scores (FSS) over 2 years versus subcutaneous interferon beta-1a (CARE-MS II; NCT00548405). Here we assess alemtuzumab's effect on FSS over 5 years. Patients received alemtuzumab at baseline and Month 12 in the core study. Patients entering an extension (NCT00930553) could receive as-needed alemtuzumab retreatment, or another disease-modifying therapy (DMT), for disease activity. EDSS was evaluated quarterly by blinded raters. 6-month confirmed FSS disability progression was defined as ≥1.0-point increase in an FSS. 393 (93%) alemtuzumab patients entered the extension; 357 (91%) remained on study through 5 years, 60% received no alemtuzumab after Month 12, and 92% received no other DMT. Over 5 years, mean cerebellar, pyramidal, sensory, and cerebral FSS did not exceed baseline; for each FSS, 71%–80% of patients were free from disability progression. Patients who received only 2 courses of alemtuzumab and no other DMT for 5 years generally had lower FSS than other patients. RRMS patients with inadequate response to prior therapy had persistent improvement/stability across multiple FSS over 5 years with alemtuzumab; most patients received no additional treatment since Month 12.

Study supported by Sanofi Genzyme and Bayer Healthcare Pharmaceuticals.

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