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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\u003EOutcomes from the Abatacept Versus Adalimumab Head-to-Head [AMPLE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00929864\u0026amp;atom=%2Fspmdc%2F12%2F19%2F15.atom\u0022\u003ENCT00929864\u003C\/a\u003E] trial demonstrated comparable efficacy between subcutaneous abatacept and adalimumab on background methotrexate. This article discusses key efficacy and safety results from the trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatoid Arthritis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EOutcomes from the Abatacept Versus Adalimumab Head-to-Head [AMPLE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00929864\u0026amp;atom=%2Fspmdc%2F12%2F19%2F15.atom\u0022\u003ENCT00929864\u003C\/a\u003E] trial demonstrated comparable efficacy between subcutaneous (SC) abatacept and adalimumab on background methotrexate (MTX). Michael E. Weinblatt, MD, Brigham and Women\u0027s Hospital, Boston, Massachusetts, USA, presented key efficacy and safety results from the trial.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EDr. Weinblatt said that AMPLE is the first head-to-head study in rheumatoid arthritis (RA) patients that is powered to compare biologic disease-modifying antirheumatic drugs (DMARD) on a background of MTX in subjects who have failed MTX therapy and are na\u00efve to biologic DMARD therapy. The hypothesis was that 12 months of treatment with SC abatacept would be noninferior to adalimumab. The primary endpoint was the proportion of subjects meeting the American College of Rheumatology 20% improvement criteria (ACR20) at 12 months.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe Phase 3b AMPLE study is a randomized, investigator-blinded, 24-month trial with a 12-month primary efficacy endpoint. In total, 646 biologic-na\u00efve patients with active RA and inadequate response to MTX were stratified by disease activity and randomized 1:1 to either abatacept 125 mg SC (without an intravenous load) weekly or adalimumab 40 mg SC biweekly, in combination with a stable dose of MTX.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EBaseline characteristics were similar in both groups. The 646 patients had a mean disease duration of about 1.8 years. Both abatacept and adalimumab showed comparable efficacy and kinetics of clinical response over the course of 1 year. At 4 weeks, 42.5% of patients in the abatacept group achieved ACR20 response versus 47.6% in the adalimumab group. At 12 months, 64.8% of the abatacept group and 63.4% of the adalimumab group achieved the primary endpoint of ACR20 response, confirming abatacept noninferiority.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ERates for low disease activity (28-joint Disease Activity Score [DAS28]-C-reactive protein [CRP] score \u22643.2) at Year 1 were 59.3% for abatacept and 61.4% for adalimumab. The respective numbers for remission (DAS28-CRP \u0026lt;2.6) were 43.3% versus 41.9%. AMPLE also included measures for changes in radiographic scores and rates of nonprogressors at Year 1. The mean joint space narrowing score (standard deviation [SD]) was 0.28 (1.92) in the abatacept group (n=290) versus 0.39 (2.50) in the adalimumab group (n=289). Numbers for radiographic nonprogressors were 246\/290 (84.8%) and 256\/289 (88.6%), respectively.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EAccording to Dr. Weinblatt, SC abatacept was noninferior to adalimumab (64.8% vs 63.4%) in the primary outcome measure of ACR20 at 1 year (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Comparable responses, including similar onset, were seen across all efficacy variables, including the ACR core components. Other than fewer discontinuations due to adverse events and serious adverse events in the SC abatacept group and significantly (p=0.006) less frequent local injection-site reaction complaints in abatacept patients, safety outcomes were balanced.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/19\/15\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022SC Abatacept Is Noninferior to Adalimumab.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1618142956\u0022 data-figure-caption=\u0022SC Abatacept Is Noninferior to Adalimumab.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/19\/15\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/19\/15\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/12\/19\/15\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/11704\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-8\u0022 class=\u0022first-child\u0022\u003ESC Abatacept Is Noninferior to Adalimumab.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EReproduced with permission from ME Weinblatt, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2012 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\/12\/19\/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_figures.js?nzn5e2\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzn5e2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}