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dc.contributor.authorColes, Alasdairen
dc.contributor.authorCohen, JAen
dc.contributor.authorFox, EJen
dc.contributor.authorGiovannoni, Gen
dc.contributor.authorHartung, HPen
dc.contributor.authorHavrdova, Een
dc.contributor.authorSchippling, Sen
dc.contributor.authorSelmaj, KWen
dc.contributor.authorTraboulsee, Aen
dc.contributor.authorCompston, Alastairen
dc.contributor.authorMargolin, DHen
dc.contributor.authorThangavelu, Ken
dc.contributor.authorChirieac, MCen
dc.contributor.authorJody, Den
dc.contributor.authorXenopoulos, Pen
dc.contributor.authorHogan, RJen
dc.contributor.authorPanzara, MAen
dc.contributor.authorArnold, DLen
dc.date.accessioned2017-09-11T14:07:40Z
dc.date.available2017-09-11T14:07:40Z
dc.date.issued2017-08-23en
dc.identifier.issn0028-3878
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/267136
dc.description.abstractObjective: 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 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.
dc.description.sponsorshipGenzyme
dc.languageEngen
dc.publisherWolters Kluwer Health
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.titleAlemtuzumab CARE-MS II 5-year follow-upen
dc.typeArticle
prism.publicationDate2017en
prism.publicationNameNeurologyen
dc.identifier.doi10.17863/CAM.13152
dcterms.dateAccepted2017-06-09en
rioxxterms.versionAMen
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en
rioxxterms.licenseref.startdate2017-08-23en
dc.contributor.orcidColes, Alasdair [0000-0003-4738-0760]
rioxxterms.typeJournal Article/Reviewen
cam.issuedOnline2017-08-23en
rioxxterms.freetoread.startdate2018-06-09


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Attribution-NonCommercial-NoDerivatives 4.0 International
Except where otherwise noted, this item's licence is described as Attribution-NonCommercial-NoDerivatives 4.0 International