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ALEMTUZUMAB IMPROVES EDSS FUNCTIONAL SYSTEMS SCORES IN RRMS
  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

Abstract

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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