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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\n      \u003Ch2\u003ESummary\u003C\/h2\u003E\n      \u003Cp id=\u0022p-1\u0022\u003EThis article discusses the efficacy and safety results from A Randomized, Placebo-Controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis, With an Open-Label Extension to Examine the Long-Term Use of Tocilizumab [TENDER; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00642460\u0026amp;atom=%2Fspmdc%2F11%2F13%2F14.atom\u0022\u003ENCT00642460\u003C\/a\u003E].\u003C\/p\u003E\n   \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003Earthritis clinical trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n      \u003Cp id=\u0022p-2\u0022\u003EFabrizio De Benedetti, MD, PhD, IRCCS Ospedale Pediatrico Bambino Ges\u00f9, Rome, Italy, presented efficacy and safety results from A Randomized, Placebo-Controlled Study to Evaluate the Effect of Tocilizumab (TCZ) on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (sJIA), With an Open-Label Extension to Examine the Long-Term Use of Tocilizumab [TENDER; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT00642460\u0026amp;atom=%2Fspmdc%2F11%2F13%2F14.atom\u0022\u003ENCT00642460\u003C\/a\u003E].\u003C\/p\u003E\n      \u003Cp id=\u0022p-3\u0022\u003EIn the TENDER trial, 112 patients aged 2 to 17 years with active, refractory sJIA (\u2265 6 months; inadequate response to previous anti-inflammatory drugs [NSAIDs] and oral corticosteroids [oral CS]) were randomly assigned 2:1 to TCZ (n=75; 8 mg\/kg if body weight \u226530 kg; 12 mg\/kg if body weight \u0026lt;30 kg) or placebo (n=37) every 2 weeks for 12 weeks in Part 1. All patients received open-label TCZ in Part 2 (to 104 weeks). Stable doses of NSAIDs and methotrexate were continued, with oral CS tapering permitted according to predefined criteria.\u003C\/p\u003E\n      \u003Cp id=\u0022p-4\u0022\u003EThe data were cut for each ongoing patient at the Week 104 infusion, based on date of randomization, with baseline in the longer-term extension considered the first dose of TCZ.\u003C\/p\u003E\n      \u003Cp id=\u0022p-5\u0022\u003EAt the data cutoff (May 31, 2011), 61 patients had received at least 104 weeks of treatment; 32 of the ongoing patients had not yet reached 104 weeks of TCZ treatment; and 20 withdrew, including 1 at Week 104 (safety, 9; insufficient therapeutic response, 5; other nonsafety issues, 6).\u003C\/p\u003E\n      \u003Cp id=\u0022p-6\u0022\u003EMain baseline characteristics included mean disease duration of 5.2 years, mean active joint count of 19.8, and presence of fever (temperature \u226537.5\u00b0C in the past 7 days) in 43% of patients. High proportions of those who were treated with TCZ achieved JIA ACR 70\/90 responses and maintained these responses over time (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E). Mean joint counts decreased over time. By Week 104, 55% of patients had 0 active joints and 31% had inactive disease status. In those patients who were taking oral CS at baseline, 60% was able to discontinue the drugs by Week 104 (\u003Ca id=\u0022xref-table-wrap-1-2\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E); mean oral CS dose decreased from 0.30 mg\/kg\/day at baseline to 0.04 mg\/kg\/day at Week 104.\u003C\/p\u003E\n      \u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\n         \u003Cdiv class=\u0022table-inline\u0022\u003E\n            \u003Cdiv class=\u0022callout\u0022\u003E\n               \u003Cspan\u003EView this table:\u003C\/span\u003E\n               \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\/12619\/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\/12619\/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\/12619\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\n            \u003C\/div\u003E\n         \u003C\/div\u003E\n         \u003Cdiv class=\u0022table-caption\u0022\u003E\n            \u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EEfficacy Endpoints (ITT Population).\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\n      \u003C\/div\u003E\n      \u003Cp id=\u0022p-16\u0022\u003EForty-seven serious adverse events (SAEs) occurred in 35 patients (\u003Ca id=\u0022xref-table-wrap-2-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T2\u0022\u003ETable 2\u003C\/a\u003E); 15 SAEs were considered by the investigator to be related (remotely, possibly, or probably) to TCZ. Twenty-two serious infection AEs were reported in 20 patients; 8 were reported as being related to TCZ (gastroenteritis, otitis media, pharyngotonsillitis, septic arthritis, streptococcal sepsis, tonsillitis, upper respiratory infection, varicella), and all but 1 resolved (patient death). At the data cutoff, 3 patients died (1, suspected tension pneumothorax; 1, road traffic accident [both reported as unrelated]; 1 suspected streptococcal sepsis [possibly treatment-related]).\u003C\/p\u003E\n      \u003Cdiv id=\u0022T2\u0022 class=\u0022table pos-float\u0022\u003E\n         \u003Cdiv class=\u0022table-inline\u0022\u003E\n            \u003Cdiv class=\u0022callout\u0022\u003E\n               \u003Cspan\u003EView this table:\u003C\/span\u003E\n               \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\/12620\/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\/12620\/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\/12620\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\n            \u003C\/div\u003E\n         \u003C\/div\u003E\n         \u003Cdiv class=\u0022table-caption\u0022\u003E\n            \u003Cspan class=\u0022table-label\u0022\u003ETable 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-17\u0022 class=\u0022first-child\u0022\u003ECumulative Safety (Safety Population; n=112).\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\n      \u003C\/div\u003E\n      \u003Cp id=\u0022p-22\u0022\u003EExcessive interleukin-6 (IL-6) production has been implicated in the pathogenesis of sJIA. TENDER study data show that treatment up to 104 weeks with the IL-6 inhibitor TCZ is highly effective, with a favorable risk-benefit ratio in patients with severe, refractory, persistent sJIA.\u003C\/p\u003E\n   \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2011 MD Conference Express\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\/11\/13\/14.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?nzmw81\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?nzmw81\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}