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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.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\u003EThis article describes the results of the phase 3, randomized, double-blind, double-dummy, active-controlled Efficacy and Safety of Daclizumab High Yield Process Versus Interferon \u03b2 1a in Patients With Relapsing-Remitting Multiple Sclerosis trial [DECIDE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01064401\u0026amp;atom=%2Fspmdc%2F14%2F29%2F15.atom\u0022\u003ENCT01064401\u003C\/a\u003E] establishing the superiority of the humanized monoclonal antibody, daclizumab high-yield process (DAC HYP), to interferon beta-1a (IFN-\u03b2-1a) in the treatment of relapsing-remitting multiple sclerosis (RRMS).\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ELudwig Kappos, MD, University Hospital, Basel, Switzerland, described the results of the phase 3, randomized, double-blind, double-dummy, active-controlled Efficacy and Safety of Daclizumab High Yield Process Versus Interferon \u03b2 1a in Patients With Relapsing-Remitting Multiple Sclerosis trial [DECIDE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01064401\u0026amp;atom=%2Fspmdc%2F14%2F29%2F15.atom\u0022\u003ENCT01064401\u003C\/a\u003E] establishing the superiority of the humanized monoclonal antibody, daclizumab high-yield process (DAC HYP), to interferon beta-1a (IFN-\u03b2-1a) in the treatment of relapsing-remitting multiple sclerosis (RRMS).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EDAC HYP selectively binds to a subunit of CD25 that is exuberantly expressed on T-cells that become abnormally activated in MS [Perry JSA et al. \u003Cem\u003ESci Transl Med.\u003C\/em\u003E 2012; Wuest SC et al. \u003Cem\u003ENat Med.\u003C\/em\u003E 2011; Martin JF et al. \u003Cem\u003EJ Immunol\u003C\/em\u003E. 2010; Bielekova B et al. \u003Cem\u003EProc Natl Acad Sci USA\u003C\/em\u003E. 2004; McDyer JF et al. \u003Cem\u003EJ Immunol\u003C\/em\u003E. 2002]. DAC HYP modulates interleukin-2 signaling without causing general immune cell depletion.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDECIDE was designed to determine if DAC HYP would provide superior outcomes for identified clinical end points compared with IFN-\u03b2-1a in greater than 1800 people with RRMS in 28 countries randomized to treatment with subcutaneous DAC HYP 150 mg every 4 weeks (n = 919) or intramuscular injection of IFN-\u03b2-1a 30 \u03bcg QW (n = 922). The primary end point was the reduction in annualized relapse rate (ARR). Secondary end points included the number of new or newly enlarging T2 hyperintense lesions on magnetic resonance imaging (MRI), the proportion of patients with sustained disability progression as determined by Extended Disability Severity Scale (EDSS) scores, the proportion of relapse-free patients, and a worsening physical impact score on the MS Impact Scale (MSIS-29).\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EBaseline demographic and clinical characteristics (duration of RRMS, relapses in previous year, EDSS score, prior treatment, the presence and number of gadolinium-enhancing [Gd+] lesions, and T2 lesions) were similar in both study arms.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary end point was met. ARR in the DAC HYP arm was 45% less than in the IFN\u03b2-1a arm (0.216 vs 0.393; 95% CI, 35.5% to 53.1%; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001). Significantly, more patients receiving DAC HYP remained relapse-free throughout the trial (overall RR 41%, \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001), with increasing divergence between the arms with time.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EWeek 96 MRI data revealed a reduction in the mean number of new and newly enlarged T2 lesions with DAC HYP (9.4 with IFN-\u03b2-1a, n = 841 vs 4.3 with DAC HYP, n = 864; 54% reduction), new Gd+ lesions (1.0 with IFN-\u03b2-1a, n = 909 vs .4 with DAC HYP, n = 900; 65% reduction), and new T1 hypointense lesions (4.4 with IFN-\u03b2-1a, n = 908 vs 2.1 with DAC HYP, n = 899; 52% reduction; all \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001).\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EConfirmed disability progression was lower in the DAC HYP arm vs IFN-\u03b2-1a, with a risk reduction of 16% (\u003Cem\u003EP\u003C\/em\u003E = .16) at 3 months in patients with suspected disease progression and 27% (\u003Cem\u003EP\u003C\/em\u003E = .0332) at 6 months in patients with confirmed disease progression; a similar pattern was seen in patients with suspected and confirmed progression with further divergence of the study arms out to week 144. More patients treated with IFN-\u03b2-1a than with DAC HYP had MSIS-29 scores that were indicative of a clinically meaningful worsening of symptoms (23% vs 19%; 24% reduction; \u003Cem\u003EP\u003C\/em\u003E = .0176). Finally, annualized brain volume change for weeks 0 to 24 and weeks 24 to 96 was lower with DAC HYP (0.67%; \u003Cem\u003EP\u003C\/em\u003E = .0325 and 0.52%; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001, respectively) vs IFN-\u03b2-1a (0.74% and 0.56%, respectively).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe number of adverse events and discontinuation rate were comparable in both arms. DAC HYP was associated with more overall serious adverse events (n = 40, 4%) than IFN-\u03b2-1a (n = 15, 2%), with more serious cutaneous events (n = 14, 2% vs n = 1, \u0026lt; 1%), and with more hepatic laboratory abnormalities (n = 59, 6% vs n = 31, 3%). These were manageable with standard monitoring and medical interventions. Discontinuation due to adverse events was higher in the DAC HYP arm (130, 14% vs 81, 9%), whereas the number of deaths was less (4 vs 1).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe researchers concluded that the DECIDE findings support the potential of DAC HYP as a once-monthly option for the treatment of patients with RRMS.\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\/15.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?nzp7k1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}