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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EImprovements in annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) score were maintained throughout 4 years following treatment with alemtuzumab for 2 years in patients with relapsing-remitting multiple sclerosis (RRMS) who relapsed on prior therapy. This article presents data from the Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00930553\u0026amp;atom=%2Fspmdc%2F14%2F29%2F10.atom\u0022\u003ENCT00930553\u003C\/a\u003E; Hartung H-P et al. ECTRIMS 2014 (poster P043)].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EImprovements in annualized relapse rate (ARR) and Expanded Disability Status Scale (EDSS) score were maintained throughout 4 years following treatment with alemtuzumab for 2 years in patients with relapsing-remitting multiple sclerosis (RRMS) who relapsed on prior therapy. Hans-Peter Hartung, MD, Heinrich Heine University, D\u00fcsseldorf, Germany, presented data from the Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab trial [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00930553\u0026amp;atom=%2Fspmdc%2F14%2F29%2F10.atom\u0022\u003ENCT00930553\u003C\/a\u003E; Hartung H-P et al. ECTRIMS 2014 (poster P043)].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EA humanized anti-CD52 monoclonal antibody, alemtuzumab is approved for the treatment of specific forms of relapsing MS in multiple countries. In the CARE-MS II trial, the ARR was reduced by 49% compared with subcutaneous interferon beta-1a (SC IFN-\u03b2-1a) at 2 years in patients with RRMS who relapsed on prior therapy [Coles AJ et al. \u003Cem\u003ELancet\u003C\/em\u003E 2012]. In addition, the reduction in relapses and improvement in MRI outcomes were maintained through year 3 during the open-label CARE-MS II extension trial, with around 80% of patients not requiring retreatment or treatment with another therapy [Fox E] et al. AAN 2013 (S41.001)]. The purpose of this analysis was to evaluate the efficacy and safety of alemtuzumab through year 4 in patients who received alemtuzumab in the core study and those who switched to alemtuzumab in the extension trial.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the phase 3 CARE-MS II trial, patients with RRMS were randomly assigned to receive 2 annual courses of alemtuzumab or SC IFN-\u03b2-1a 3 times per week for 2 years [Coles AJ et al. \u003Cem\u003ELancet\u003C\/em\u003E 2012]. Patients who completed CARE-MS II were eligible to enroll in the extension study, in which patients who had received alemtuzumab in the core trial received alemtuzumab retreatment as needed and patients who switched from SC IFN-\u03b2-1a received alemtuzumab at the beginning of the extension period and 12 months later, then retreatment as needed [Fox EJ et al. AAN 2013 (S41.001)].\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EOf the 393 patients from the alemtuzumab arm in CARE-MS II who enrolled in the extension trial, 68% did not require retreatment with alemtuzumab and only 5% required treatment with another disease-modifying therapy (DMT). The reduction in ARR achieved during CARE-MS II at years 0 to 2 (0.26 with alemtuzumab vs 0.52 with SC IFN-\u03b2-1a) was maintained through year 4 with a rate of 0.23. In addition, the change in EDSS from baseline was maintained or improved in 69.2% of patients at year 4.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EIn patients who switched from SC IFN-\u03b2-1a to alemtuzumab, the ARR was decreased by 71% (from 0.52 to 0.15) during the first 2 years of alemtuzumab treatment.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe majority of adverse events (AEs) were mild to moderate and were similar to those observed in the core trial, with common AEs including nasopharyngitis, urinary tract infection, and upper respiratory tract infection throughout 4 years. Thyroid AEs occurred with a cumulative incidence of 34.7% during the 4 years, which peaked in year 3 and decreased in year 4. Discontinuation of alemtuzumab due to treatment-related AEs occurred in 4.1% of patients who received alemtuzumab in the core trial and 4.2% in patients who received SC IFN-\u03b2-1a in the core trial.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EIn conclusion, Prof Hartung indicated that the data from this analysis show that improvements in ARR and EDSS achieved with alemtuzumab treatment for 2 years were maintained throughout 4 years, with a minority of patients requiring retreatment. In addition, there were no unexpected AEs.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/29\/10.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzp7bp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}