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  1. Alasdair Coles1,
  2. Douglas Arnold2,3,
  3. Frederik Barkhof4,
  4. Massimo Filippi5,
  5. Hans-Peter Hartung6,
  6. Eva Havrdova7,
  7. Krzysztof Selmaj8,
  8. David Margolin9,
  9. Karthinathan Thangavelu9,
  10. Sven Schippling10,
  11. on behalf of the CARE-MS I and CARE-MS II Investigators1
  1. 1 University of Cambridge
  2. 2 NeuroRx Research, Québec, Canada
  3. 3 Montréal Neurological Institute, McGill University, Montréal, Québec, Canada
  4. 4 University Medical Centre, Amsterdam, The Netherlands
  5. 5 Vita-Salute San Raffaele University, Milan, Italy
  6. 6 Heinrich-Heine University, Düsseldorf, Germany
  7. 7 First Medical Faculty, Charles University in Prague, Czech Republic
  8. 8 Medical University of Łódź, Poland
  9. 9 Sanofi Genzyme
  10. 10 Neuroimmunology and Multiple Sclerosis Research, University Hospital Zurich and University of Zurich


Patients with active relapsing-remitting MS (RRMS) who were treatment-naive (CARE-MS I; NCT00530348) or with inadequate response (≥1 relapse) to prior therapy (CARE-MS II; NCT00548405) demonstrated improved efficacy with alemtuzumab versus subcutaneous interferon beta-1a over 2 years, including slowing of brain volume loss (BVL). Here we examine alemtuzumab's effect on BVL over 5 years. Patients who received alemtuzumab at baseline and Month 12 in the core studies could enter an ongoing extension (NCT00930553), receiving as-needed alemtuzumab retreatment for disease activity. MRI scans were acquired at baseline and annually. BVL was measured by relative brain parenchymal fraction change. 349 (95%) CARE-MS I and 393 (93%) CARE-MS II alemtuzumab patients entered the extension. Of those, 68% and 60% received no alemtuzumab since Month 12; 98% and 92% received no other disease-modifying therapy. Median yearly BVL decreased over 4 years in CARE-MS I, remaining low in Year 5 (Year 1: −0.59%, Year 2: −0.25%, Year 3: −0.19%, Year 4: −0.15%, Year 5: −0.20%). The pattern was similar in CARE-MS II (Year 1: −0.48%, Year 2: −0.22%, Year 3: −0.10%, Year 4: −0.19%, Year 5: −0.07%). Slowing of BVL with alemtuzumab was maintained over 5 years, despite most patients not receiving treatment for 4 years.

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