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Durable efficacy of alemtuzumab on clinical outcomes over 5 years in treatment-naive patients with active relapsing-remitting multiple sclerosis with most patients not receiving treatment for 4 years: CARE-MS I extension study
Author(s): ,
E. Havrdova
Affiliations:
First Medical Faculty, Charles University in Prague, Prague, Czech Republic
,
D.L. Arnold
Affiliations:
NeuroRx Research; Montréal Neurological Institute, McGill University, Montréal, QC, Canada
,
J.A. Cohen
Affiliations:
Cleveland Clinic, Cleveland, OH, United States
,
D.A.S. Compston
Affiliations:
University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom
,
E.J. Fox
Affiliations:
Central Texas Neurology Consultants, Round Rock, TX, United States
,
H.-P. Hartung
Affiliations:
Heinrich-Heine University, Düsseldorf, Germany
,
K.W. Selmaj
Affiliations:
Medical University of Łódź, Łódź, Poland
,
D.H. Margolin
Affiliations:
Genzyme, a Sanofi company
,
L. Kasten
Affiliations:
PROMETRIKA, LLC, Cambridge, MA, United States
,
M.A. Panzara
Affiliations:
Genzyme, a Sanofi company
,
A.J. Coles
Affiliations:
University of Cambridge School of Clinical Medicine, Cambridge, United Kingdom
on behalf of the CARE-MS I Investigators
on behalf of the CARE-MS I Investigators
Affiliations:
ECTRIMS Online Library. Havrdova E. Oct 9, 2015; 116625; 58
Prof. Eva Havrdova
Prof. Eva Havrdova
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Abstract: 152

Type: Oral

Abstract Category: Long-term treatment monitoring

Background: In CARE-MS I (NCT00530348), alemtuzumab had a superior effect on relapse versus subcutaneous interferon beta-1a over 2 years, with a manageable and consistent safety profile, in treatment-naive patients with active relapsing-remitting multiple sclerosis (RRMS). Alemtuzumab's efficacy was durable through 4 years, despite most patients not receiving alemtuzumab or other disease-modifying (DMT) therapy since Month 12.

Goals: To examine 5-year efficacy and safety in patients who received alemtuzumab in CARE-MS I.

Methods: In CARE-MS I, patients with active disease (≥1 relapse in the past year and ≥2 in the past 2 years) received 2 annual courses of alemtuzumab 12 mg. In the ongoing extension (NCT00930553), as-needed alemtuzumab retreatment was available ≥1 year apart based on evidence of disease activity (eg, relapse or magnetic resonance imaging activity). Endpoints included annualised relapse rate (ARR), sustained accumulation of disability (SAD; ≥1-point Expanded Disability Status Scale [EDSS] increase over 6 months [≥1.5-point if baseline EDSS=0]), EDSS score improvement or worsening (≥0.5-point decrease or increase from baseline), and sustained reduction in preexisting disability (SRD; ≥1-point EDSS decrease from baseline over 6 months [baseline score ≥2.0]).

Results: 349 (95%) alemtuzumab-treated patients completing CARE-MS I enrolled in the extension. Through 5 years, 318 (91%) remained on study, 68% did not receive alemtuzumab since Month 12, and 2% received another DMT. The low ARR was maintained from Year 3 (0.19) to Year 5 (0.15). Through Years 0-5, 80% of patients were free from 6-month SAD and 69% had stable/improved EDSS scores. An additional 9% of patients achieved 6-month SRD from Years 2-5 (33% total Years 0-5). Incidences of infusion-associated reactions and infections during the extension were reduced versus core study, and serious adverse event (AE) incidence was low. Thyroid AE incidence peaked at Year 3 and subsequently declined.

Conclusion: Alemtuzumab's efficacy was maintained for 5 years, despite most patients not receiving additional treatment over the previous 4 years. Incidence of most AEs during the extension study was comparable or reduced compared with core study, and thyroid AEs declined after Year 3. Durable efficacy of alemtuzumab may result from immunomodulatory effects of the distinct pattern of lymphocyte repopulation following treatment, representing a novel treatment approach for RRMS.

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

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

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, NeuroRxResearch, Novartis, OpexaTherapeutics, Receptos, Roche, Sanofi, and Teva); holds stock in NeuroRxResearch.

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

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.

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

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

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:
Employee of Genzyme.

LK:
Provides statistical support as a consultant for Genzyme.

MAP:
Employee of Genzyme.

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

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