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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.
Mult Scler. 2020 12; 26(14):1866-1876.MS

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.

Authors+Show Affiliations

Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy.Department of Medicine, Amiri Hospital, Sharq, Kuwait.OhioHealth Neurological Physicians, Columbus, OH, USA.Neurology Center of San Antonio, San Antonio, TX, USA.Keck School of Medicine, University of Southern California, Los Angeles, CA, USA/Regina Berkovich, MD, PhD, Inc., West Hollywood, CA, USA.Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.Research Institute and Hospital, National Cancer Center, Goyang, South Korea.Klinik für Neurologie und Palliativmedizin, Cologne, Germany.Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.Department of Neurology, Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia.NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK.MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, F-59000 Lille, France.Department of Neurology, University of Münster, Münster, Germany.Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.Sanofi, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA.Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada.No affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31762387

Citation

Comi, Giancarlo, et al. "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." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 26, no. 14, 2020, pp. 1866-1876.
Comi G, Alroughani R, Boster AL, et al. 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. Mult Scler. 2020;26(14):1866-1876.
Comi, G., Alroughani, R., Boster, A. L., Bass, A. D., Berkovich, R., Fernández, Ó., Kim, H. J., Limmroth, V., Lycke, J., Macdonell, R. A., Sharrack, B., Singer, B. A., Vermersch, P., Wiendl, H., Ziemssen, T., Jacobs, A., Daizadeh, N., Rodriguez, C. E., & Traboulsee, A. (2020). 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. Multiple Sclerosis (Houndmills, Basingstoke, England), 26(14), 1866-1876. https://doi.org/10.1177/1352458519888610
Comi G, et al. 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. Mult Scler. 2020;26(14):1866-1876. PubMed PMID: 31762387.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Comi,Giancarlo, AU - Alroughani,Raed, AU - Boster,Aaron L, AU - Bass,Ann D, AU - Berkovich,Regina, AU - Fernández,Óscar, AU - Kim,Ho Jin, AU - Limmroth,Volker, AU - Lycke,Jan, AU - Macdonell,Richard Al, AU - Sharrack,Basil, AU - Singer,Barry A, AU - Vermersch,Patrick, AU - Wiendl,Heinz, AU - Ziemssen,Tjalf, AU - Jacobs,Alan, AU - Daizadeh,Nadia, AU - Rodriguez,Claudio E, AU - Traboulsee,Anthony, AU - ,, Y1 - 2019/11/25/ PY - 2019/11/26/pubmed PY - 2019/11/26/medline PY - 2019/11/26/entrez KW - Alemtuzumab KW - efficacy KW - multiple sclerosis KW - relapse KW - retreatment KW - safety SP - 1866 EP - 1876 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult Scler VL - 26 IS - 14 N2 - 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. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/31762387/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_ L2 - https://journals.sagepub.com/doi/10.1177/1352458519888610?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -
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