Alemtuzumab CARE-MS II 5-year follow-up Efficacy and safety findings

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

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

170 Citations (Web of Science)

Abstract

Objective: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy.

Methods: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity. 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) were assessed.

Results: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3-5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1-5: 20.48%, 20.22%, 20.10%, 20.19%, 20.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter.

Conclusions: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment.

Original languageEnglish
Pages (from-to)1117-1126
Number of pages10
JournalNeurology
Volume89
Issue number11
DOIs
Publication statusPublished - 12 Sep 2017

Keywords

  • REMITTING MULTIPLE-SCLEROSIS
  • CONTROLLED PHASE-3 TRIAL
  • BRAIN ATROPHY
  • INTERFERON BETA-1A
  • DISEASE-ACTIVITY
  • THYROID-CANCER
  • NATALIZUMAB
  • FINGOLIMOD
  • THERAPY
  • SWITCH

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