Alemtuzumab CARE-MS I 5-year follow-up: Durable efficacy in the absence of continuous MS therapy

Eva Havrdova*, Douglas L. Arnold, Jeffrey A. Cohen, Hans-Peter Hartung, Edward J. Fox, Gavin Giovannoni, Sven Schippling, Krzysztof W. Selmaj, Anthony Traboulsee, D. Alastair S. Compston, David H. Margolin, Karthinathan Thangavelu, Claudio E. Rodriguez, Darlene Jody, Richard J. Hogan, Panos Xenopoulos, Michael A. Panzara, CARE-MS I CAMMS03409 Investigators, Raymond Hupperts, Alasdair J. Coles

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

138 Citations (Web of Science)

Abstract

Objective: To evaluate 5-year efficacy and safety of alemtuzumab in treatment-naive patients with active relapsing-remitting MS (RRMS) (CARE-MS I; NCT00530348).

Methods: Alemtuzumab-treated patients received treatment courses at baseline and 12 months later; after the core study, they could enter an extension (NCT00930553) with as-needed alemtuzumab retreatment for relapse or MRI activity. Assessments included annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; $1-point Expanded Disability Status Scale [EDSS] score increase [$1.5 if baseline EDSS 5 0]), 6-month confirmed disability improvement (CDI; $1-point EDSS decrease [baseline score $2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs).

Results: Most alemtuzumab-treated patients (95.1%) completing CARE-MS I enrolled in the extension; 68.5% received no additional alemtuzumab treatment. ARR remained low in years 3, 4, and 5 (0.19, 0.14, and 0.15). Over years 0-5, 79.7% were free of 6-month CDW; 33.4% achieved 6-month CDI. Most patients (61.7%, 60.2%, and 62.4%) had NEDA in years 3, 4, and 5. Median yearly BVL improved over years 2-4, remaining low in year 5 (years 1-5: 20.59%, 20.25%, 20.19%, 20.15%, and 20.20%). Exposure-adjusted incidence rates of most AEs declined in the extension relative to the core study. Thyroid disorder incidences peaked at year 3 and subsequently declined.

Conclusions: Based on these data, alemtuzumab provides durable efficacy through 5 years in the absence of continuous treatment, with most patients not receiving additional courses.

Original languageEnglish
Pages (from-to)1107-1116
Number of pages10
JournalNeurology
Volume89
Issue number11
DOIs
Publication statusPublished - 12 Sep 2017

Keywords

  • MULTIPLE-SCLEROSIS PATIENTS
  • CONTROLLED PHASE-3 TRIAL
  • LONG-TERM DISABILITY
  • BRAIN ATROPHY
  • INTERFERON-BETA

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