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Alemtuzumab slows brain volume loss over 5 years in patients with active relapsing-remitting multiple sclerosis with most patients not receiving treatment for 4 years: CARE MS I and II extension study
Author(s): ,
F. Barkhof
Affiliations:
VU University Medical Centre, Amsterdam, The Netherlands
,
J.A. Cohen
Affiliations:
Cleveland Clinic, Cleveland, OH, United States
,
A.J. Coles
Affiliations:
University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom
,
D.A.S. Compston
Affiliations:
University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom
,
M. Filippi
Affiliations:
San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy
,
E.J. Fox
Affiliations:
Central Texas Neurology Consultants, Round Rock, TX, United States
,
G. Giovannoni
Affiliations:
Queen Mary University of London, Barts and The London School of Medicine, London, United Kingdom
,
H.-P. Hartung
Affiliations:
Heinrich-Heine University, Düsseldorf, Germany
,
E. Havrdova
Affiliations:
First Medical Faculty, Charles University in Prague, Prague, Czech Republic
,
S. Schippling
Affiliations:
Neuroimmunology and Multiple Sclerosis Research, Department of Neurology, University Hospital Zurich and University of Zurich, Zurich, Switzerland
,
K.W. Selmaj
Affiliations:
Medical University of Łódź, Łódź, Poland
,
D.H. Margolin
Affiliations:
Genzyme, a Sanofi company, Cambridge, MA, United States
,
K. Thangavelu
Affiliations:
Genzyme, a Sanofi company, Cambridge, MA, United States
,
M.A. Panzara
Affiliations:
Genzyme, a Sanofi company, Cambridge, MA, United States
,
D.L. Arnold
Affiliations:
NeuroRx Research, Montréal, QC, Canada; Montréal Neurological Institute, McGill University, Montréal, QC, Canada
on behalf of the CARE-MS I and CARE-MS II Investigators
on behalf of the CARE-MS I and CARE-MS II Investigators
Affiliations:
ECTRIMS Online Library. Barkhof F. Oct 9, 2015; 116687; 1896
Prof. Dr. Frederik Barkhof
Prof. Dr. Frederik Barkhof
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Abstract: 151

Type: Oral

Abstract Category: Long-term treatment monitoring

Background: In two phase 3 trials in patients with active relapsing-remitting multiple sclerosis (RRMS), alemtuzumab had superior efficacy versus subcutaneous interferon beta-1a (SC IFNB-1a), including a significant slowing of brain volume (BV) loss over 2 years; in active treatment-naive patients in CARE-MS I (NCT00530348) by 42% and in patients who had an inadequate response (≥1 relapse) to a prior therapy, in CARE-MS II (NCT00548405) by 24%. Slowing of BV loss was durable through 4 years, despite most patients not receiving alemtuzumab retreatment since Month 12 or another disease-modifying therapy (DMT).

Goals: To examine alemtuzumab's effect on BV change over 5 years in patients who participated in the CARE-MS study program and ongoing extension study.

Methods: The CARE-MS studies enrolled patients with active RRMS (≥1 relapse in the past year and ≥2 in the past 2 years). Patients randomised to alemtuzumab received 2 annual courses of alemtuzumab 12 mg, at Month 0 and Month 12. In the extension study (NCT00930553), as-needed alemtuzumab retreatment was available based on evidence of disease activity (eg, relapse or magnetic resonance imaging [MRI] activity). Patients could receive another DMT at the investigator's discretion. MRI scans were acquired at baseline and annually thereafter. BV loss was measured by relative brain parenchymal fraction change.

Results: 349 (95%) CARE-MS I and 393 (93%) CARE-MS II alemtuzumab patients entered the extension study. Of those, 68% in CARE-MS I and 60% in CARE-MS II did not receive alemtuzumab treatment since Month 12, and 2% and 8% received another DMT. Median rate of BV loss decreased progressively over 4 years in CARE-MS I and remained low in Year 5 (Year 1: -0.59%, Year 2: -0.25%, Year 3: -0.19%, Year 4: -0.15%, Year 5: -0.20%). Median rate of BV loss progressively slowed over 3 years in CARE-MS II and remained low in Years 4 and 5 (Year 1: -0.48%, Year 2: -0.22%, Year 3: -0.10%, Year 4: -0.19%, Year 5: -0.07%).

Conclusion: Slowing of BV loss with alemtuzumab was maintained over 5 years in patients who were treatment-naive or had an inadequate response to prior therapy, despite most patients not receiving additional treatment over the previous 4 years. The durable effect on slowing BV loss may result from a reduction in inflammation and the immunomodulatory effects of the distinct pattern of lymphocyte repopulation following treatment with alemtuzumab, which represents a novel treatment approach for RRMS.

Disclosure:

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

FB: Consultancy fees or honoraria (Bayer Schering Pharma, Biogen Idec, Genzyme, Janssen Research, Merck-Serono, Novartis, Roche, Sanofi, SynthonBV, and Teva); compensation for speaker bureau participation (Serono Symposia Foundation, MedScape); research support paid to his institution (Biogen Idec, Dutch MS Society, Janssen Research, Merck-Serono, Novartis, Roche, SynthonBV, and Teva).

JAC: Personal compensation for serving as a consultant or speaker (EMD Serono, Genentech, Innate Immunotherapeutics, and Vaccinex).

AJC: Consulting fees, lecture fees, and institutional grant support (Genzyme).

DASC: Consulting fees and grant support (Genzyme) and lecture fees (Bayer Schering Pharma) on behalf of the University of Cambridge; and personal remuneration for lecture fees (Genzyme) from July 2014.

MF: Personal compensation (Bayer-Schering, Biogen Idec, Merck-Serono, and Teva), research support (Bayer Schering Pharma, Biogen Idec, Merck Serono, Teva Pharmaceutical Industries, Italian Ministry of Health; Fondazione Italiana Sclerosi Multipla, Cure PSP, Alzheimer´s Drug Discovery Foundation, Jacques and Gloria Gossweiler Foundation, and AriSLA [Fondazione Italiana di Ricerca per la SLA]), and compensation in an editorial capacity (Journal of Neurology).

EJF:
Consultancy fees, honoraria, travel, and research support (Bayer Healthcare, Biogen Idec, Eli Lilly, EMD Serono, Genzyme, Novartis, Ono, Opexa Therapeutics, Pfizer, Sanofi, and Teva).

GG:
Compensation for consulting, serving on a scientific advisory board, speaking, or other activities (Biogen Idec, Five Prime Therapeutics, Genzyme, GW Pharma, Merck Serono, Novartis, Roche, Synthon, Teva, and Vertex Pharmaceuticals); compensation for serving as a journal editor (Multiple Sclerosis and Related Disorders); and research support (Serono).

H-PH: Honoraria for consulting and speaking at symposia (Bayer Healthcare, Biogen Idec, CSL Behring, Genzyme, Merck Serono, Novartis, Octapharma, Roche, Teva, and Sanofi, with approval by the Rector of Heinrich Heine-University).

EH: Honoraria and consulting fees (Bayer, GlaxoSmithKline, Genzyme, Biogen Idec, Sanofi, Merck Serono, Roche, Teva, and Novartis); consulting services, speaking and serving on scientific advisory boards and research support (Czech Ministry of Education).

SS: Nothing to disclose.

KWS:
Consulting fees (Biogen Idec, Genzyme, Novartis, and Roche); lecture fees (Bayer Healthcare Pharmaceuticals, Biogen Idec, Merck Serono, and Novartis), and financial compensation for scientific presentations (Genzyme).

DHM, KT and MAP:
Compensation as employees of Genzyme.

DLA:
Compensation for serving as a speaker, consultant, and advisory board participant, and receiving research support (Acorda, Bayer, Biogen Idec, Canadian Institutes of Health Research, Eli Lilly, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, MedImmune, Merck Serono, MS Society of Canada, NeuroRx Research, Novartis, Opexa Therapeutics, Receptos, Roche, Sanofi, and Teva); holds stock in NeuroRx Research.
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