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• W2561520336 abstract "OBJECTIVE: To examine alemtuzumab efficacy in treatment-naive patients with highly active relapsing-remitting MS (RRMS).BACKGROUND: In CARE-MS I (NCT00530348), alemtuzumab significantly reduced clinical and MRI disease activity versus SC IFNB-1a over 2 years in the highly active patient subgroup. Efficacy was durable through 4 years, despite most receiving no therapy since Month 12.DESIGN/METHODS: Patients received courses of alemtuzumab at baseline and Month 12 in the core study. Patients could enter the extension (NCT00930553), with as-needed retreatment for relapse or radiological activity, or another disease-modifying therapy (DMT) at the investigator’s discretion. Highly active disease was ≥2 relapses in year before randomization and ≥1 baseline gadolinium-enhancing lesion. No evidence of disease activity (NEDA) was absence of MRI (new gadolinium-enhancing and new/enlarging T 2 lesions) and clinical (6-month confirmed disability progression or relapse) activity. Brain volume loss was measured by change in brain parenchymal fraction.RESULTS: The extension enrolled 99/105 (94[percnt]) highly active alemtuzumab-treated patients from CARE-MS I. Through 5 years, 68[percnt] received only the initial 2 courses; 94[percnt] did not receive another DMT. In the extension (Years 3-5), annualized relapse rate was 0.18, 64[percnt] of patients had no evidence of clinical disease activity, and 49[percnt] had no evidence of MRI disease activity. NEDA was observed in 58[percnt], 58[percnt], and 61[percnt] of patients in Years 3, 4, and 5, respectively, and 34[percnt] had NEDA sustained over Years 3-5. Annual median percent change in brain parenchymal fraction in Year 5 was -0.22[percnt].CONCLUSIONS: Efficacy was durable through Year 5 in patients with baseline highly active disease, despite most not receiving treatment since Month 12. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continued treatment for patients with highly active RRMS.STUDY SUPPORTED BY: Genzyme, a Sanofi company, and Bayer Healthcare Pharmaceuticals. Disclosure: Dr. Krieger has received personal compensation for activities with Acorda, Bayer, Biogen, EMD Serono, Genentech, Genzyme, Novartis, Questcor, Takeda, and Teva for consulting and non promotional lectures. Dr. Singer has received personal compensation for activities with Acorda, Bayer, Biogen Idec, EMD Serono, Genzyme, Novartis Pharmaceuticals Corporation, Pfizer, and Teva. Dr. Freedman has received research support from Bayer Healthcare and Genzyme. Dr. Lycke has received research support from Novartis, Biogen , and TEVA CNS. Dr. Berkovich has received personal compensation for activities with Acorda, Avanir Pharmaceuticals, Bayer, Biogen Idec, Genzyme, Novartis, Questcor, and Teva as an advisory board member and/or consultant. Dr. Margolin has received personal compensation for activities with Genzyme as an employee. Dr. Thangavelu has received personal compensation for activities with Genzyme as an employee. Dr. Havrdovahas has received research support from Czech Ministry of Education." @default.
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• W2561520336 date "2016-04-05" @default.
• W2561520336 modified "2023-09-22" @default.
• W2561520336 title "Treatment-Naive Patients with Highly Active RRMS Demonstrated Durable Efficacy with Alemtuzumab over 5 Years (S51.003)" @default.
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