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

Author:

Comi Giancarlo1,Alroughani Raed2ORCID,Boster Aaron L3,Bass Ann D4,Berkovich Regina5,Fernández Óscar6,Kim Ho Jin7,Limmroth Volker8,Lycke Jan9ORCID,Macdonell Richard AL10,Sharrack Basil11,Singer Barry A12,Vermersch Patrick13,Wiendl Heinz14,Ziemssen Tjalf15ORCID,Jacobs Alan16,Daizadeh Nadia16,Rodriguez Claudio E16,Traboulsee Anthony17,Baker Darren P.,Bueno Ericka M.,Mitchell Colin,Orndorff Rebecca L.,Zediak Valerie P.

Affiliation:

1. Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy

2. Department of Medicine, Amiri Hospital, Sharq, Kuwait

3. OhioHealth Neurological Physicians, Columbus, OH, USA

4. Neurology Center of San Antonio, San Antonio, TX, USA

5. Keck School of Medicine, University of Southern California, Los Angeles, CA, USA/Regina Berkovich, MD, PhD, Inc., West Hollywood, CA, USA

6. Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain

7. Research Institute and Hospital, National Cancer Center, Goyang, South Korea

8. Klinik für Neurologie und Palliativmedizin, Cologne, Germany

9. Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden

10. Department of Neurology, Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia

11. NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK

12. MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA

13. Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, F-59000 Lille, France

14. Department of Neurology, University of Münster, Münster, Germany

15. Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany

16. Sanofi, Cambridge, MA, USA

17. Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada

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.

Funder

bayer healthcare

Sanofi

Publisher

SAGE Publications

Subject

Neurology (clinical),Neurology

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