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. (December 2020)

• Record Type: Journal Article
• Authors: Comi, Giancarlo; Alroughani, Raed; Boster, Aaron L; Bass, Ann D; Berkovich, Regina; Fernández, Óscar; Kim, Ho Jin; Limmroth, Volker; Lycke, Jan; Macdonell, Richard AL; Sharrack, Basil; Singer, Barry A; Vermersch, Patrick; Wiendl, Heinz; Ziemssen, Tjalf; Jacobs, Alan; Daizadeh, Nadia; Rodriguez, Claudio E; Traboulsee, Anthony
• Other Names: Baker Darren P. non-byline-author.; Bueno Ericka M. non-byline-author.; Mitchell Colin non-byline-author.; Orndorff Rebecca L. non-byline-author.; Zediak Valerie P. non-byline-author.
• Is Part Of: Multiple sclerosis. Volume 26:Number 14(2020)
• Page Start: 1866
• Page End: 1876
• Publication Date: 2020-12
• Subjects: Alemtuzumab -- efficacy -- multiple sclerosis -- relapse -- retreatment -- safety; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458519888610
• Languages: English
• ISSNs: 1352-4585

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.