Durable Effect of Alemtuzumab on MRI Outcomes in Patients With Relapsing-Remitting Multiple Sclerosis Who Relapsed on Prior Therapy: 4-Year Follow-up of CARE-MS II (P7.249)

Abstract

OBJECTIVE: Examine the effect of alemtuzumab on 4-year magnetic resonance imaging (MRI) outcomes in CARE-MS II patients who entered an ongoing extension. BACKGROUND: In the CARE-MS II trial (NCT00548405), alemtuzumab had superior benefit versus subcutaneous interferon beta-1a, including improved MRI outcomes over 2 years, in relapsing-remitting multiple sclerosis (RRMS) patients who relapsed on prior therapy. DESIGN/METHODS: Core study patients randomized to alemtuzumab received 12 mg/day intravenously on 5 consecutive days and on 3 consecutive days 12 months later. In the extension study (NCT00930553), alemtuzumab-treated patients could receive as-needed retreatment 蠅1 year after the 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, and MRI activity (absence of Gd-enhancing and new/enlarging T2 lesions). RESULTS: 393 (92.9[percnt]) CARE-MS II alemtuzumab-treated patients entered the extension; data are available through 4 years from first treatment, and follow-up is ongoing. Through 4 years, 67.7[percnt] of patients received only the initial 2 courses of treatment, 24.2[percnt] received 1 additional course, and 7.4[percnt] received 2 additional courses. In Year 3 and Year 4, the proportions of patients free of Gd-enhancing (86.5[percnt] and 89.1[percnt]), new/enlarging T2 (69.0[percnt] and 70.3[percnt]) or new T1 lesions (87.5[percnt] and 86.3[percnt]) remained stable. Most patients were MRI activity-free at Year 3 (68.4[percnt]) and Year 4 (69.9[percnt]). CONCLUSIONS: The majority of alemtuzumab patients remained free of new lesions and MRI activity in Year 4 despite 68[percnt] of the patients receiving their last treatment course 3 years previously. These findings support the durable efficacy of alemtuzumab in this RRMS population. Study Supported by: Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals

Disclosure: Dr. Traboulsee has received personal compensation for activities with Roche Diagnostics Corporation, EMD Serono, Teva Neuroscience, and Biogen Idec, Novartis, and Genzyme Corporation. Dr. Coles has received personal compensation for activities with Genzyme as a speaker. Dr. Cohen has received personal compensation for activities with Biogen Idec, Eli Lilly, Novartis, and Vaccinex as a consultant and/or speaker. Dr. Compston has received personal compensation for activities with Genzyme and Lundbeck Research USA, Inc. Dr. Fox has received personal compensation for activities Acorda Therapeutics, Bayer Pharmaceuticals Corporation, Biogen Idec, Eli Lilly & Company, EMD Serono, Genzyme Corporation, GlaxoSmithKline, and Novartis. Dr. Hartung has holds stock and/or stock options from Opexa Therapeutics. Dr. Havrdova has received research support from the Czech Ministries of Education and Health. Dr. Selmaj has received personal compensation for activities with Genzyme Corporation, Novartis, Ono Pharmaceutical, Roche Diagnostics Corporation, Synthon, Teva Neuroscience, and Biogen Idec. as a consultant and/or speaker. Dr. Margolin has received personal compensation for activities with Genzyme as an employee., Dr. Zhao has received personal compensation for activities with Genzyme Corporation as an employee. Dr. Panzara has received personal compensation for activities with Genzyme as an employee. Dr. Arnold has received personal compensation for activities with Acorda, Bayer Healthcare, Biogen Idec, Merck Serono, Genentech, Genzyme, GlaxoSmithKline, Medimmune, Novartis, Receptos, Inc., Roche, Sanofi-Aventis, and Teva.