DX05
Durable Effect of Alemtuzumab on MRI Activity and Brain Atrophy in Relapsing-Remitting Multiple Sclerosis Patients: 4-Year Follow-up of Care-MS II

Friday, May 29, 2015: 3:20 PM
White River F
Anthony Traboulsee, MD , The University of British Columbia, Vancouver, BC, Canada
Hans-Peter Hartung, MD, FRCP, FAAN, FANA , Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany
Eva Havrdova, MD, PhD , First Faculty of Medicine and General University Hospital, Charles University in Prague, Prague, Czech Republic
Krzysztof W Selmaj, MD, PhD , Department of Neurology, Medical Academy of Lodz, Lodz, Poland
D Alastair S Compston, MD , University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom
David H Margolin, MD, PhD , Sanofi Genzyme, Cambridge, MA
Linda Kasten, MA , PROMETRIKA, LLC, Cambridge, MA
Douglas L Arnold, MD , McGill University, Montreal, QC, Canada


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Background:  In the CARE-MS II trial (NCT00548405), alemtuzumab had superior effects versus subcutaneous interferon beta-1a, including improved magnetic resonance imaging (MRI) outcomes over 2 years, in relapsing-remitting multiple sclerosis (RRMS) patients with an inadequate efficacy response to prior therapy.

Objectives: Examine the effect of alemtuzumab on 4-year MRI outcomes in CARE-MS II patients who entered an ongoing extension.

Methods:  In the CARE-MS II core study, patients with ≥1 relapse after ≥6 months on prior therapy were randomized to alemtuzumab and received 12 mg/day intravenously on 5 consecutive days and on 3 consecutive days 12 months later. In the extension study (NCT00930553), these patients could receive as-needed retreatment ≥1 year after a previous course. MRI scans were acquired at baseline and yearly thereafter. MRI outcomes included gadolinium (Gd)-enhancing, new/enlarging T2 hyperintense and new T1 hypointense lesion activity, freedom from MRI activity (absence of Gd-enhancing and new/enlarging T2 lesions), and brain volume loss measured by brain parenchymal fraction (BPF) change.

Results:  393 (92.9%) CARE-MS II alemtuzumab-treated patients entered the extension. Through 4 years, 67.7% of patients received only the initial 2 courses of treatment, 24.2% received 1 additional course, and 7.4% received 2 additional courses. In Year 3 and Year 4, the proportions of patients free of Gd-enhancing (86.5% and 89.1%), new/enlarging T2 (69.0% and 70.3%), or new T1 lesions (87.5% and 86.3%) remained stable. Most patients were MRI activity-free at Year 3 (68.4%) and Year 4 (69.9%). Median rate of BPF loss progressively slowed over 3 years and remained low in Year 4 (Year 1: –0.48%, Year 2: –0.22%, Year 3: –0.10%, Year 4: –0.19%).

Conclusions:  The majority of alemtuzumab patients remained free of new lesions and MRI activity in Years 3 and 4 despite most patients not receiving more than the initial 2 treatment courses, and slowing of brain volume loss was maintained over the 4-year period. These findings support the durable efficacy of alemtuzumab in this RRMS population.

Study supported by Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals.

See more of: Disease Management, Mechanisms, and Treatment (Platform/Oral)
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