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dc.contributor.authorColes, AJen_US
dc.contributor.authorCohen, JAen_US
dc.contributor.authorFox, EJen_US
dc.contributor.authorGiovannoni, Gen_US
dc.contributor.authorHartung, H-Pen_US
dc.contributor.authorHavrdova, Een_US
dc.contributor.authorSchippling, Sen_US
dc.contributor.authorSelmaj, KWen_US
dc.contributor.authorTraboulsee, Aen_US
dc.contributor.authorCompston, DASen_US
dc.contributor.authorMargolin, DHen_US
dc.contributor.authorThangavelu, Ken_US
dc.contributor.authorChirieac, MCen_US
dc.contributor.authorJody, Den_US
dc.contributor.authorXenopoulos, Pen_US
dc.contributor.authorHogan, RJen_US
dc.contributor.authorPanzara, MAen_US
dc.contributor.authorArnold, DLen_US
dc.contributor.authorCARE-MS II and CAMMS03409 Investigatorsen_US
dc.description.abstractOBJECTIVE: To evaluate 5-year efficacy and safety of alemtuzumab in patients with active relapsing-remitting multiple sclerosis and inadequate response to prior therapy. METHODS: In the 2-year Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis (CARE-MS) II study (NCT00548405), alemtuzumab-treated patients received 2 courses (baseline and 12 months later). Patients could enter an extension (NCT00930553), with as-needed alemtuzumab retreatment for relapse or MRI activity. Annualized relapse rate (ARR), 6-month confirmed disability worsening (CDW; ≥1-point Expanded Disability Status Scale [EDSS] score increase [≥1.5 if baseline EDSS = 0]), 6-month confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline score ≥2.0]), no evidence of disease activity (NEDA), brain volume loss (BVL), and adverse events (AEs) were assessed. RESULTS: Most alemtuzumab-treated patients (92.9%) who completed CARE-MS II entered the extension; 59.8% received no alemtuzumab retreatment. ARR was low in each extension year (years 3-5: 0.22, 0.23, 0.18). Through 5 years, 75.1% of patients were free of 6-month CDW; 42.9% achieved 6-month CDI. In years 3, 4, and 5, proportions with NEDA were 52.9%, 54.2%, and 58.2%, respectively. Median yearly BVL remained low in the extension (years 1-5: -0.48%, -0.22%, -0.10%, -0.19%, -0.07%). AE exposure-adjusted incidence rates in the extension were lower than in the core study. Thyroid disorders peaked at year 3, declining thereafter. CONCLUSIONS: Alemtuzumab provides durable efficacy through 5 years in patients with an inadequate response to prior therapy in the absence of continuous treatment. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that alemtuzumab provides efficacy and slowing of brain atrophy through 5 years.en_US
dc.description.sponsorshipSupported by Sanofi and Bayer HealthCare Pharmaceuticals. A.J. Coles reports institutional grant support from Sanofi Genzyme E. Havrdova reports grant support from Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi Genzyme, and Teva, and is supported by Ministry of Education of Czech Republic, project PROGRES Q27/LF1. S. Schippling reports research grants from Novartis and Sanofi Genzyme D.A.S. Compston reports grant support from Genzymeen_US
dc.format.extent1117 - 1126en_US
dc.subjectAntibodies, Monoclonal, Humanizeden_US
dc.subjectDisability Evaluationen_US
dc.subjectFollow-Up Studiesen_US
dc.subjectImmunologic Factorsen_US
dc.subjectKaplan-Meier Estimateen_US
dc.subjectMultiple Sclerosis, Relapsing-Remittingen_US
dc.subjectOrgan Sizeen_US
dc.subjectTime Factorsen_US
dc.subjectTreatment Outcomeen_US
dc.titleAlemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings.en_US
dc.rights.holder2017 The Authors.
pubs.notesNot knownen_US

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