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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 presents the 48-week results of the Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis and Multiple Joint Involvement Who Have Poor Response to Methotrexate [GO KIDS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01230827\u0026amp;atom=%2Fspmdc%2F14%2F51%2F17.atom\u0022\u003ENCT01230827\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology Clinical Trials Arthritis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatological Autoimmune Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EArthritis\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatological Autoimmune Disorders\u003C\/li\u003E\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EChildren with juvenile idiopathic arthritis (JIA) treated with subcutaneous golimumab (GLM) showed a rapid response during the initial 16 weeks of treatment, which resulted in inactive disease in 34% of the patients. Despite this response, at week 48, there was no difference in flare rate between patients who continued on GLM and those randomized to placebo.\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EHermine I. Brunner, MD, Cincinnati Children\u0027s Hospital Medical Center, Cincinnati, Ohio, USA, presented the 48-week results of the Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate [GO KIDS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01230827\u0026amp;atom=%2Fspmdc%2F14%2F51%2F17.atom\u0022\u003ENCT01230827\u003C\/a\u003E].\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe multicenter, double-blind, randomized-withdrawal phase 3 trial involved 2 parts. In the first part, 173 children with JIA received GLM 30 mg\/m\u003Csup\u003E2\u003C\/sup\u003E every 4 weeks with methotrexate (MTX) until week 16. In part 2, children who achieved clinical response at week 16 were randomized to placebo or continued GLM from week 16 to week 48, with GLM given to patients in the placebo group on flare.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EPatients included in this analysis were children aged 2 to 17 years with JIA, active arthritis involving \u2265 5 joints despite \u0026gt; 3 months of MTX at 10 to 30 mg\/m\u003Csup\u003E2\u003C\/sup\u003E, disease duration of \u2265 6 months, and prior exposure to one anti-tumor necrosis factor drug or background therapy with a stable dose of prednisone.\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EPatients were excluded if they had current or prior uveitis, latent or active tuberculosis or other chronic infection, a history of severe progressive or uncontrolled liver or renal insufficiency (or significant other organ involvement), or a history of or current malignancy.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003EThe primary end point of the study was the proportion of treatment responders at week 16 who did not display flare-up to week 48. Among the secondary end points was the proportion of patients with inactive disease status in part 2.\u003C\/p\u003E\n         \u003Cp id=\u0022p-8\u0022\u003EFor part 1, the study found that 151 of 173 (87.3%) children achieved a 30% improvement from baseline in 3 of 6 criteria. Overall, 34.3% of children displayed inactive disease status at the end of part 1 of the study.\u003C\/p\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EHowever, the study failed to reach its primary end point because no difference was found in flares at week 48 between patients randomized to placebo and those given GLM (52.6% vs 59.0%; \u003Cem\u003EP\u003C\/em\u003E = .414). The study also found no difference in patients with inactive disease from weeks 16 through 48 between GLM and placebo.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EOn secondary analysis, the study found that only patients with elevated baseline C-reactive protein level had a higher chance of flaring at week 48. However, baseline CRP levels did not influence the response rates to GLM.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EIn conclusion, the study failed to meet the primary end point as a result of differences in flare rate between the GLM and placebo arms in part 2 of the study. Because of these negative findings, Dr Brunner said that the development program for GLM in JIA has been discontinued.\u003C\/p\u003E\n      \u003C\/div\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\/51\/17.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?nzoeo2\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}