5th Joint triennial congress of the European and Americas Committees
for Treatment and Research in Multiple Sclerosis
Amsterdam, The Netherlands

19.10.2011 - 22.10.2011
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Home - 22.10.2011 - Late breaking News

Late breaking News

Saturday, October 22, 2011, 09:15 - 09:30

Efficacy and safety results from CARE-MS I: a phase 3 study comparing alemtuzumab and interferon-beta-1a

A. Coles, V. Brinar, D.L. Arnold, J. Cohen, C. Confavreaux, E.J. Fox, H.-P. Hartung, E. Havrdova, K. Selmaj, H. Weiner, G. Giovannoni, S.L. Lake, D.H. Margolin, M. Panzara, D.A.S. Compston (Cambridge, GB; Zagreb, HR; Montreal, CA; Cleveland, US; Lyon, FR; Round Rock, US; Düsseldorf, DE; Prague, CZ; Lodz, PL; Boston, US; London, GB; Cambridge, US)

Objective: Presentation of top line clinical efficacy and safety results from phase 3 pivotal study: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis I (CARE-MS I)
Background: Alemtuzumab is an anti-CD52 humanized monoclonal antibody that alters the circulating lymphocyte pool. Alemtuzumab was significantly more effective than subcutaneous interferon-beta-1a (SC IFNB-1a) in a phase 2 trial (CAMMS223) with relapsing-remitting multiple sclerosis (RRMS) patients. CARE-MS I is a phase 3 trial designed to confirm the efficacy and safety of alemtuzumab versus SC INFB-1a.
Methods: CARE-MS I is a 2-year, randomised, rater-blinded, active-comparator, global trial comparing the safety and efficacy of alemtuzumab to IFNB-1a in active, treatment-naïve RRMS patients. Patients received 2 annual short cycles (5 days and 3 days) of 12 mg/day intravenous alemtuzumab or 44 mcg SC IFNB-1a 3 x weekly for 24 months. Entry criteria included: age 18-50 years; MS symptom onset <= 5 years; baseline Expanded Disability Status Score (EDSS) <=3; 2 or more relapses in the 24 months prior to study entry; and at least 1 attack in the 12 months prior to study entry. The primary efficacy endpoints are relapse rate and time to sustained accumulation of disability (SAD). SAD is defined as an >=1 point increase in EDSS lasting >=6 months (or >=1.5 point increase if baseline EDSS <1). Blinded raters assessed EDSS quarterly, and relapses as needed. Safety was assessed continuously. The protocol included a safety education and monitoring program for early detection of identified secondary autoimmune disorders as part of a proactive risk mitigation strategy.
Results: 581 patients from 97 centres in 16 countries were randomised 2:1 to alemtuzumab or IFNB-1a. Baseline characteristics (mean unless otherwise specified) were: age 33 yrs; disease duration 2.1 yrs; EDSS 2.0; relapses in year prior to study entry 1.7 (median 2.0); number of enhancing lesions 2.2; 47% of patients had an enhancing lesion. Database lock will occur in June, 2011; final clinical efficacy and safety results including relapse and disability outcomes will be presented.
Conclusions: If positive, CARE-MS I will confirm alemtuzumab's ability to slow or reverse the accumulation of physical disability and reduce the frequency of clinical exacerbations in early, active RRMS patients compared with SC IFNB-1a; and further characterize the benefit/risk profile and potential of this promising new treatment.

Dr. Alasdair J. Coles reports receiving consulting fees, lecture fees and institutional grant support from Genzyme, Merck Serono and UCB-Celltech. Dr. Edward Fox reports receiving consultancy fees, honoraria, travel and research support from Bayer, Novartic, Ono, and Sanofi, Biogen Idec, EMD Serono, Genzyme, Opexa Therapeutics, Pfizer, Teva Neuroscience and Eli Lilly. Dr. Krzysztof Selmaj reports receiving consulting fees from Genzyme, Novartis, Biogen, and Roche; he has received lecture fees from Novartis, Merck-Serono, Biogen, and Bayer; and received financial compensation including travel from Genzyme for presentation at ECTRIMS 2010. Prof. Alastair Compston reports receiving consulting fees, lecture fees and grant support from Genzyme and lecture fees from Bayer Schering Pharma on behalf of himself and the University of Cambridge. Drs. Vesna Brinar, Doug L. Arnold, Jeffrey Cohen, Christian Confavreaux, H.P. Hartung, Eva Havrdova, Howard Weiner, and Gavin Giovannoni report no conflicts of interest. Dr. David H. Margolin, Stephen L. Lake, and Michael Panzara receives personal compensation as an employee of Genzyme (a company of Sanofi-Aventis). Funding provided by Genzyme and Bayer Healthcare Pharmaceuticals.