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Title: | 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 | Authors: | VAN WIJMEERSCH, Bart Singer, Barry A. Boster, Aaron Broadley, Simon Fernandez, Oscar Freedman, Mark S. Izquierdo, Guillermo Lycke, Jan Pozzilli, Carlo Sharrack, Basil Steingo, Brian Wiendl, Heinz Wray, Sibyl Ziemssen, Tjalf Chung, Luke Margolin, David H. Thangavelu, Karthinathan Vermersch, Patrick |
Issue Date: | 2020 | Publisher: | SAGE PUBLICATIONS LTD | Source: | MULTIPLE SCLEROSIS JOURNAL, 26 (13), p. 1719-1728 | Abstract: | 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. ClinicalTrials.gov registration numbers:CARE-MS I, II, extension: NCT00530348, NCT00548405, NCT00930553. | Notes: | Van Wijmeersch, B (reprint author), Hasselt Univ, Fac Med & Life Sci, Campus Hasselt,Martelarenlaan 42, B-3500 Hasselt, Belgium. bart.vanwijmeersch@uhasselt.be |
Other: | Van Wijmeersch, B (reprint author), Hasselt Univ, Fac Med & Life Sci, Campus Hasselt,Martelarenlaan 42, B-3500 Hasselt, Belgium. bart.vanwijmeersch@uhasselt.be | Keywords: | Alemtuzumab;disease-modifying therapy;relapsing-remitting multiple sclerosis (MS);efficacy;magnetic resonance imaging (MRI);disability | Document URI: | http://hdl.handle.net/1942/30883 | ISSN: | 1352-4585 | e-ISSN: | 1477-0970 | DOI: | 10.1177/1352458519881759 | ISI #: | WOS:000495335100001 | Rights: | The Author(s), 2019. ( CC-BY-NC )Article reuse guidelines: sagepub.com/journalspermissions | Category: | A1 | Type: | Journal Contribution | Validations: | ecoom 2020 |
Appears in Collections: | Research publications |
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van-wijmeersch-et-al-2019-efficacy-of-alemtuzumab-over-6-years-in-relapsing-remitting-multiple-sclerosis-patients-who.pdf | Published version | 814.73 kB | Adobe PDF | View/Open |
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