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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\u003EThe new agent HD203 is a biosimilar of etanercept, a recombinant fusion protein that blocks tumor necrosis factor activity. The amino acid sequence of HD203 is identical to that of etanercept and is produced by the same method. The objective of the Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients [HERA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01270997\u0026amp;atom=%2Fspmdc%2F14%2F17%2F15.atom\u0022\u003ENCT01270997\u003C\/a\u003E] was to evaluate the equivalence in efficacy of HD203 and etanercept in combination with methotrexate in patients with rheumatoid arthritis (RA).\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatoid Arthritis Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology\u003C\/li\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\u003EThe new agent HD203 is a biosimilar of etanercept, a recombinant fusion protein that blocks tumor necrosis factor activity. The amino acid sequence of HD203 is identical to that of etanercept and is produced by the same method. A Phase 1 trial in healthy volunteers indicated that the pharmacokinetics, safety, and tolerability of HD203 were comparable to those of etanercept [Yi S et al. \u003Cem\u003EBioDrugs\u003C\/em\u003E 2012].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe objective of the Trial to Evaluate Equivalence in Efficacy and Safety of HD203 and Enbrel in RA Patients [HERA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01270997\u0026amp;atom=%2Fspmdc%2F14%2F17%2F15.atom\u0022\u003ENCT01270997\u003C\/a\u003E], presented by Sang-Cheol Bae, MD, PhD, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, was to evaluate the equivalence in efficacy of HD203 and etanercept in combination with methotrexate in patients with rheumatoid arthritis (RA). The patients were randomly assigned to HD203 (25 mg; n=115) or etanercept (25 mg; n=118), subcutaneous injection, twice weekly, for 24 weeks. An extension study continued for an additional 24 weeks.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe inclusion criteria included fulfillment of 1987 American College of Radiology (ACR) criteria for RA; class I to III ACR functional status; active RA; positive rheumatoid factor, anti-CCP antibody, or bone erosion in the hands or feet; and inadequate response to methotrexate. The primary efficacy endpoint was the ACR20 score, assessed at Week 24. The secondary endpoints were ACR20, ACR50, and ACR70, assessed at Weeks 12, 24, and 48, and the index of improvement in RA, Disease Activity Score in 28 joints (DAS28), and European League Against Rheumatism (EULAR) response, assessed at Weeks 24 and 48. Efficacy equivalence was defined as a 95% CI between the 2 drugs of \u221220% to +20%.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe mean patient age was \u223c51 years in each group, and 85.6% to 87.8% of patients were women. ACR functional status was similar between the 2 groups. The primary endpoint of ACR20 at Week 24 was achieved by 83.48% of patients in the HD203 group, compared with 81.36% of patients in the etanercept group (95% CI, 7.65 to 11.89; p=0.6706).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThere were no significant differences between the groups in the percentage of patients achieving ACR20 at Weeks 12 and 48; ACR50 at Week 12; and ACR70 at Weeks 12, 24, and 48 (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). A significant difference was observed for ACR50 in the HD203 group versus the etanercept group at Weeks 24 (65.2% vs 52.5%; p=0.0494) and 48 (68.2% vs 54.5%; p=0.0359).\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/14589\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/14589\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/14589\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003ESecondary Endpoints: ACR Responses per Protocol Set, n (%)\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EAt Weeks 24 and 48, there were no significant differences between the groups in mean change in DAS28 (Week 24, p=0.9170; Week 48, p=0.2534) or EULAR response rate (Week 24, p=0.5991; Week 48, p=0.1264).\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EThe adverse event (AE) rate at 48 weeks was 76.9% in the HD203 group and 78.1% in the etanercept group. Serious AEs were reported in 12.9% of HD203 patients and 12.3% of etanercept patients. The withdrawal rate was 6.8% in the HD203 group and 7.5% in the etanercept group. Ten patients in the HD203 group and 4 in the etanercept group developed transient antidrug antibodies over 48 weeks.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003EThis study demonstrated the equivalent efficacy and comparable safety of HD203 and etanercept in patients with RA. These findings confirm the biosimilarity of the 2 drugs.\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\/17\/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?nzp3e1\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_tables.js?nzp3e1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}