Alemtuzumab improves preexisting disability in active relapsing-remitting MS patients

Gavin Giovannoni, Jeffrey A. Cohen, Alasdair J. Coles, Hans-Peter Hartung, Eva Havrdova, Krzysztof W. Selmaj, David H. Margolin, Stephen L. Lake, Susan M. Kaup, Michael A. Panzara, Xavier Montalban, D. Alastair S. Compston

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46 Citations (Scopus)


Objective: To characterize effects of alemtuzumab treatment on measures of disability improvement in patients with relapsing-remitting multiple sclerosis (RRMS) with inadequate response (>= 1 relapse) to prior therapy.Methods: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II, a 2-year randomized, rater-blinded, active-controlled, head-to-head, phase 3 trial, compared efficacy and safety of alemtuzumab 12 mg with subcutaneous interferon-beta-1a (SC IFN-beta-1a) 44 mg in patients with RRMS. Prespecified and post hoc disability outcomes based on Expanded Disability Status Scale (EDSS), Multiple Sclerosis Functional Composite (MSFC), and Sloan low-contrast letter acuity (SLCLA) are reported, focusing on improvement of preexisting disability in addition to slowing of disability accumulation.Results: Alemtuzumab-treated patients were more likely than SC IFN-beta-1a-treated patients to show improvement in EDSS scores (p < 0.0001) on all 7 functional systems. Significantly more alemtuzumab patients demonstrated 6-month confirmed disability improvement. The likelihood of improved vs stable/worsening MSFC scores was greater with alemtuzumab than SC IFN-beta-1a (p = 0.0300); improvement in MSFC scores with alemtuzumab was primarily driven by the upper limb coordination and dexterity domain. Alemtuzumab-treated patients had more favorable changes from baseline in SLCLA (2.5% contrast) scores (p = 0.0014) and MSFC + SLCLA composite scores (p = 0.0097) than SC IFN-beta-1a-treated patients.Conclusions: In patients with RRMS and inadequate response to prior disease-modifying therapies, alemtuzumab provides greater benefits than SC IFN-beta-1a across several disability outcomes, reflecting improvement of preexisting disabilities.Classification of evidence: This study provides Class I evidence (based on rater blinding and a balance in baseline characteristics between arms) that alemtuzumab modifies disability measures favorably compared with SC IFN-beta-1a.
Original languageEnglish
Pages (from-to)1985-1992
Number of pages8
Issue number19
Early online date12 Oct 2016
Publication statusPublished - 8 Nov 2016


  • Sclerosis functional composite
  • Placebo-controlled trial
  • Multiple-sclerosis
  • Controlled phase-3
  • Natalizumab
  • Progression
  • Therapy
  • Impact


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