Alemtuzumab Decreased MRI Disease Activity Through 6 Years in Patients With Highly Active RRMS and an Inadequate Response to Prior Therapy: CARE-MS II Extension Study (S12.006)

Objective: Evaluate 6-year MRI outcomes in CARE-MS II alemtuzumab-treated patients with highly active disease at baseline. Background: CARE-MS II (NCT00548405) patients with highly active relapsing-remitting MS (≥2 relapses in the year before randomization and ≥1 gadolinium [Gd]-enhancing lesion) and an inadequate response (≥1 relapse) to prior therapy at baseline showed significantly reduced disease activity with alemtuzumab versus SC IFNB-1a over 2 years. Previous results from an extension study (NCT00930553) demonstrated durable efficacy on clinical and MRI outcomes over 5 years in this population in the absence of continuous treatment. Design/Methods: Patients received 2 courses of alemtuzumab 12 mg (baseline: 5 days; Month 12: 3 days), with as-needed alemtuzumab for relapse or MRI activity, or another disease-modifying therapy (DMT) per investigator discretion. MRI scans were conducted at baseline and annually thereafter. Endpoints included proportion of patients free of MRI disease activity (Gd-enhancing T 1 and new/enlarging T 2 hyper intense lesions), and proportion free of new non-enhancing T 1 hypointense lesions. Results: 92 of the 103 (89%) patients with highly active disease who received alemtuzumab in the 2-year core study entered the extension; of these, 86 (93%) remained on study 4 years later (Year 6). In Year 6, 87%, 66%, and 89% of patients were free of Gd-enhancing T 1 , new/enlarging T 2 , and new non-enhancing T 1 lesions, respectively, consistent with results observed in Years 3–5. In each extension year, most patients were free of MRI disease activity (Year 3: 65%, Year 4: 67%, Year 5: 70%, Year 6: 65%). Efficacy results were achieved, with 55% of patients receiving no additional alemtuzumab or other DMT. Conclusions: Alemtuzumab improved MRI outcomes through 6 years in patients with highly active RRMS and may provide a unique approach in this patient population, offering durable efficacy in the absence of continuous treatment. Study Supported by: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals. Disclosure: Dr. Rovira has received personal compensation for activities with Genzyme, Novartis, Biogen, Bracco, and Teva. Dr. Boster has received personal compensation for activities with Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi Genzyme, and Teva for consulting or non-CME services. Dr. Comi has received personal compensation for activities with Novartis, Teva, Sanofi, Genzyme, Merck Serono, Biogen, Serono Symposia International Foundation, Excemed, Roche Almirall, Chugai, Receptos, and Forward Pharma. Dr. Berkovich has received personal compensation for activities with Acorda, Avanir, Bayer, Biogen, Sanofi Genzyme, Novartis, Questcor, and Teva Neuroscience as an Advisory Board Member and a consultant. Dr. Pelletier has received personal compensation for activities with CNS Imaging Consultant, LLC as a consultant. Dr. Schippling has received personal compensation for activities with Bayer Healthcare, Biogen, Sanofi Genzyme, Merck Serono, Novartis, and TEVA. Dr. Schippling has received research support from Sanofi Genzyme and Novartis. Dr. Traboulsee has received personal compensation for activities with Genzyme and Roche as a consultant. Dr. Traboulsee has received research support from Genzyme, Roche, and Chugai. Dr. LaGanke has received personal compensation for activities with Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB as a consultant. Dr. Margolin has received personal compensation for activities with Sanofi Genzyme as an employee. Dr. Santra has received personal compensation for activities with Sanofi Genzyme as a consultant. Dr. Arnold has received personal compensation for activities with Coronado Biosciences, Consortium of Multiple Sclerosis Centers, Eli Lilly, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, MS Forum, NeuroRx Research, Novartis, Opexa Therapeutics, Roche, Merck Serono, S.A. Serono Symposia International Foundation, Teva, the Canadian Institutes of Health Research, and the Multiple Sclerosis Society of Canada. Dr. Arnold holds stock and/or stock options in NeuroRx Research. Dr. Investigators has nothing to disclose.