Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies

Giancarlo Comi, Raed Alroughani, Aaron L. Boster, Ann D. Bass, Regina Berkovich, Óscar Fernández, Ho Jin Kim, Volker Limmroth, Jan Lycke, Richard A.L. Macdonell, Basil Sharrack, Barry A. Singer, Patrick Vermersch, Heinz Wiendl, Tjalf Ziemssen, Alan Jacobs, Nadia Daizadeh, Claudio E. Rodriguez, Anthony Traboulsee, Darren P. BakerEricka M. Bueno, Colin Mitchell, Rebecca L. Orndorff, Valerie P. Zediak

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Alemtuzumab is given as two annual courses. Patients with continued disease activity may receive as-needed additional courses. Objective: To evaluate efficacy and safety of additional alemtuzumab courses in the CARE-MS (Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis) studies and their extensions. Methods: Subgroups were based on the number of additional alemtuzumab courses received. Exclusion criteria: other disease-modifying therapy (DMT); <12-month follow-up after last alemtuzumab course. Results: In the additional-courses groups, Courses 3 and 4 reduced annualized relapse rate (12 months before: 0.73 and 0.74, respectively; 12 months after: 0.07 and 0.08). For 36 months after Courses 3 and 4, 89% and 92% of patients were free of 6-month confirmed disability worsening, respectively, with 20% and 26% achieving 6-month confirmed disability improvement. Freedom from magnetic resonance imaging (MRI) disease activity increased after Courses 3 and 4 (12 months before: 43% and 53%, respectively; 12 months after: 73% and 74%). Safety was similar across groups; serious events occurred irrespective of the number of courses. Conclusion: Additional alemtuzumab courses significantly improved outcomes, without increased safety risks, in CARE-MS patients with continued disease activity after Course 2. How this compares to outcomes if treatment is switched to another DMT instead remains unknown.

Original languageEnglish
Pages (from-to)1866-1876
Number of pages11
JournalMultiple Sclerosis Journal
Volume26
Issue number14
DOIs
Publication statusPublished - Dec 2020

Keywords

  • Alemtuzumab
  • efficacy
  • multiple sclerosis
  • relapse
  • retreatment
  • safety

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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