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

• Bart Van Wijmeersch
• Barry A Singer
• Aaron Boster, OhioHealth
• Simon Broadley
• Óscar Fernández
• Mark S Freedman
• Guillermo Izquierdo
• Jan Lycke
• Carlo Pozzilli
• Basil Sharrack
• Brian Steingo
• Heinz Wiendl
• Sibyl Wray
• Tjalf Ziemssen
• Luke Chung
• David H Margolin
• Karthinathan Thangavelu
• Patrick Vermersch

Document Type

Article

Publication Title

Multiple sclerosis (Houndmills, Basingstoke, England)

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

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.

First Page

1719

Last Page

1728

DOI

10.1177/1352458519881759

Publication Date

11-1-2020

Recommended Citation

Van Wijmeersch B, Singer BA, Boster A, Broadley S, Fernández Ó, Freedman MS, Izquierdo G, Lycke J, Pozzilli C, Sharrack B, Steingo B, Wiendl H, Wray S, Ziemssen T, Chung L, Margolin DH, Thangavelu K, Vermersch P. 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. Mult Scler. 2020 Nov;26(13):1719-1728. doi: 10.1177/1352458519881759. Epub 2019 Nov 1. PMID: 31675266; PMCID: PMC7604550.