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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\u003ESignificantly more subjects with relapsing-remitting multiple sclerosis achieved freedom from measured disease activity when treated with peginterferon beta-1a every 2 weeks compared with those who were treated with peginterferon beta-1a every 4 weeks or placebo. This article presents results from a post hoc analysis of 48-week data from the Efficacy and Safety Study of BIIB017 (PEGylated Interferon Beta-1a) in Participants With Relapsing Multiple Sclerosis trial [ADVANCE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00906399\u0026amp;atom=%2Fspmdc%2F14%2F6%2F10.atom\u0022\u003ENCT00906399\u003C\/a\u003E].\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 Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDemyelinating Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ESignificantly more subjects with relapsing-remitting multiple sclerosis (RRMS) achieved freedom from measured disease activity (FMDA) when treated with peginterferon beta-1a every 2 weeks (Q2W) compared with those who were treated with peginterferon beta-1a every 4 weeks (Q4W) or placebo, said Douglas Arnold, MD, McGill University, Montreal, Quebec, Canada, who presented results from a post hoc analysis of 48-week data from the Efficacy and Safety Study of BIIB017 (PEGylated Interferon Beta-1a) in Participants With Relapsing Multiple Sclerosis trial [ADVANCE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00906399\u0026amp;atom=%2Fspmdc%2F14%2F6%2F10.atom\u0022\u003ENCT00906399\u003C\/a\u003E].\u003C\/p\u003E\u003Cp\u003EADVANCE was a Phase 3 multicenter double-blind study with subjects with RRMS and an Expanded Disability Status Scale (EDSS) \u00a35, who were randomly assigned to treatment with peginterferon beta-1a 125 \u03bcg Q2W or Q4W for 96 weeks or to placebo for 48 weeks, then 1 of the 2 peginterferon beta-1a dosing regimens for 48 weeks. Magnetic resonance imaging (MRI) was conducted at baseline and Weeks 24 and 48. Participants were assessed for\n\u003C\/p\u003E\u003Col class=\u0022list-ord \u0022 id=\u0022list-1\u0022\u003E\u003Cli id=\u0022list-item-1\u0022\u003E\n               \u003Cp id=\u0022p-4\u0022\u003EMRI freedom from measured disease activity (FMDA; defined as no gadolinium-enhancing [Gd+] lesions and no new or newly enlarging T2 lesions at Week 48 compared with baseline)\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-2\u0022\u003E\n               \u003Cp id=\u0022p-5\u0022\u003Eclinical freedom from measured disease activity (defined as no relapses or 12-week confirmed disability progression over 48 weeks), and\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-3\u0022\u003E\n               \u003Cp id=\u0022p-6\u0022\u003Ea composite of both conditions (overall FMDA). A sensitivity analysis was performed using a definition with minimal MRI allowance (no Gd+ lesions at Weeks 24 and 48 and \u22641 new or newly enlarging T2 lesions at Week 48 compared with baseline).\u003C\/p\u003E\n            \u003C\/li\u003E\u003C\/ol\u003E\u003Cp\u003E\n      \u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EThe primary outcome was annualized relapse rate (ARR) at Week 48.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003ESubjects (n=1516) had a mean age of approximately 36 years, approximately 71% were women, and most (\u221282%) were white. The mean time since first MS symptom was 6.5 years. A mean of 1.6 relapses had occurred within the previous 12 months. Mean EDSS score was 2.46, and mean T2 lesions and GD+ lesions were 50 and 1.5, respectively.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe primary results of ADVANCE showed that after 48 weeks, both peginterferon beta-1a dose regimens were associated with a significantly reduced relapse rate compared with placebo. These results have already been published [Calabresi PA et al. \u003Cem\u003ELancet Neurol\u003C\/em\u003E 2014]. Additionally, interim 2-year results support the maintenance of benefit and the significantly greater efficacy of the Q2W dose regime (vs the Q4W regime) [Deykin A et al. \u003Cem\u003ENeurology\u003C\/em\u003E 2014].\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EThe objective of the post hoc analysis presented by Dr. Arnold was to assess FMDA in patients treated with peginterferon beta-1a during Year 1 of ADVANCE. Results of the analysis showed that significantly more subjects receiving Q2W dosing achieved overall FMDA from baseline to Week 48 (33.9%) compared with those receiving placebo (15.1%; p\u0026lt;0.0001) or Q4W dosing (21.5%; p\u0026lt;0.0001). Between Week 24 and Week 48, 60.2% of subjects receiving Q2W dosing achieved FMDS compared with 28.9% receiving placebo (p\u0026lt;0.0001) or Q4W dosing (36.6%; p\u0026lt;0.0001) Subjects on the Q4W dosing were more like to achieve overall FMDA than were those receiving placebo.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EAmong subjects achieving MRI FMDA only, significantly (p\u0026lt;0.0001) higher proportions were from the group receiving Q2W dosing compared with those receiving placebo or Q4W dosing at both time points. Subjects in the Q4W dosing group were significantly (p\u0026lt;0.05) more likely to achieve MRI FMDA compared with those receiving placebo.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EAt both time points (baseline to Week 48 or Week 24 to Week 48), subjects in the Q2W dosing group were significantly (p\u0026lt;0.001) more likely to achieve clinical FMDA than were those receiving placebo or Q4W dosing. However, the proportion of patients achieving clinical FMDA was not significantly different between the 2 peginterferon beta-1a dosing regimens.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EThe robustness of these findings was confirmed with sensitivity analyses allowing for minimal MRI activity. Peginterferon beta-1a Q2W values were significantly (p\u0026lt;0.0001) greater than placebo and Q4W values. Q4W values were significantly (p\u0026lt;0.02) greater than placebo values.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EThese data, along with previous findings, support the use of peginterferon beta-1a as an effective treatment for patients with RRMS, with the benefit of less frequent subcutaneous administration.\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\/6\/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?nzpa3q\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}