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Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies

Journal article
Authors B. Van Wijmeersch
B. A. Singer
A. Boster
S. Broadley
O. Fernandez
M. S. Freedman
G. Izquierdo
Jan Lycke
C. Pozzilli
B. Sharrack
B. Steingo
H. Wiendl
S. Wray
T. Ziemssen
L. Chung
D. H. Margolin
K. Thangavelu
P. Vermersch
Published in Multiple Sclerosis Journal
ISSN 1352-4585
Publication year 2019
Published at Institute of Neuroscience and Physiology
Language en
Keywords Alemtuzumab, disease-modifying therapy, relapsing-remitting multiple, sclerosis (MS), efficacy, magnetic resonance imaging (MRI), disability, interferon, therapy, natalizumab, disability, disease, trial, Neurosciences & Neurology
Subject categories Neurosciences


Background:Alemtuzumab is administered as two annual courses for relapsing-remitting multiple sclerosis (MS). Patients may relapse before completing the two-course regimen. Objective: The objective was to evaluate 6-year outcomes in patients who relapsed between alemtuzumab Courses 1 and 2 (early relapsers). Methods:Post hoc analysis of patients from the Comparison of Alemtuzumab and Rebif (R) Efficacy in Multiple Sclerosis (CARE-MS) studies who enrolled in the extension. Results:Early relapsers (CARE-MS I: 15%; CARE-MS II: 24%) had more relapses in 1-2 years pre-alemtuzumab and higher mean baseline Expanded Disability Status Scale score than patients without relapse. Their annualized relapse rate declined from Year 1 (CARE-MS I: 1.3; CARE-MS II: 1.2) to Year 2 following Course 2 (0.3; 0.5) and remained low thereafter. Over 6 years, 60% remained free of 6-month confirmed disability worsening; 24% (CARE-MS I) and 34% (CARE-MS II) achieved 6-month confirmed disability improvement. During Year 6, 69% (CARE-MS I) and 68% (CARE-MS II) were free of magnetic resonance imaging (MRI) disease activity. Median percent yearly brain volume loss (Year 1: -0.67% (CARE-MS I); -0.47% (CARE-MS II)) declined after Course 2 (Year 6: -0.24%; -0.13%). Conclusion: Early relapsers' outcomes improved after completing the second alemtuzumab course. These findings support administering the approved two-course regimen to maximize clinical benefit. registration numbers:CARE-MS I, II, extension: NCT00530348, NCT00548405, NCT00930553.

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