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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\u003EAn investigational selective inhibitor of Janus kinase 1 (JAK1) was found to improve\n               clinical endpoints with a favorable safety profile in a Phase 2a dose-ranging study\n               of patients with rheumatoid arthritis (RA). This article discusses the results of a\n               4-week double-blind, placebo-controlled study of GLPG0634, an orally-available,\n               selective inhibitor of JAK1, in patients with active RA [Vanhoutte FP et al. EULAR\n               2013 (poster 0229)].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatoid Arthritis\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\u003C\/ul\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \n         \u003Cp id=\u0022p-2\u0022\u003EAn investigational selective inhibitor of Janus kinase 1 (JAK1) was found to improve\n            clinical endpoints with a favorable safety profile in a Phase 2a dose-ranging study of\n            patients with rheumatoid arthritis (RA).\u003C\/p\u003E\n         \u003Cp id=\u0022p-3\u0022\u003EFr\u00e9d\u00e9ric P. Vanhoutte, MD, Galapagos NV, Mechelen, Belgium, presented the results of a\n            4-week double-blind, placebo-controlled study of GLPG0634, an orally-available,\n            selective inhibitor of JAK1, in patients with active RA [Vanhoutte FP et al. EULAR 2013\n            (poster 0229)]. JAKs are critical components of signaling mechanisms used by a number of\n            cytokines and growth factors, including those that are elevated in patients with RA.\n            GLPG0634 had demonstrated encouraging efficacy and safety in a 4-week proof-of-concept\n            trial in RA.\u003C\/p\u003E\n         \u003Cp id=\u0022p-4\u0022\u003EThe current study was conducted in 91 patients with active RA who had an insufficient\n            response to methotrexate (MTX) and were na\u00efve to biological agents. They were randomized\n            to GLPG0634 at doses of 30, 75, 150, and 300 mg, or placebo, all once daily. All\n            patients continued to take their stable background therapy of MTX.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003EThe mean duration of RA was 4.4 years in the placebo group compared with 7.9 to 10.0\n            years in the active treatment groups. Mean scores on the disability activity score in 28\n            joints (DAS28) C-reactive protein (CRP) at baseline ranged from 5.7 to 6.4. The group\n            randomized to 150 mg of GLPG0634 had worse disease at baseline than the other groups, as\n            evident by the longest duration of RA (10 years), the highest DAS28 score (6.4), and the\n            highest scores (worst) on the Health Assessment Questionnaire-Disability Index (HAQ-DI),\n            tender joint count (TJC), and swollen joint count (SJC).\u003C\/p\u003E\n         \u003Cp id=\u0022p-6\u0022\u003EDose-dependent improvements in CRP, DAS28-CRP, American College of Rheumatology 20%\n            improvement criteria (ACR20), ACR50, TJC, SJC, and HAQ-DI were found for GLPG0634, with\n            little improvement at the 30-mg dose and the best results achieved with the 300-mg dose.\n            Relative to placebo, statistically significant improvements were found with GLPG0634 on\n            CRP, DAS28, ACR50, and HAQ-DI.\u003C\/p\u003E\n         \u003Cp id=\u0022p-7\u0022\u003ESeveral efficacy endpoints showed statistical significance in favor of GLPG0634 (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). The reduction in CRP\n            level from baseline ranged from 15 to 21 mg\/L (p\u0026lt;0.01 for all 3 doses vs placebo).\n            All GLPG0634 dose levels also showed improvement in DAS28 (\u22121.7 to \u22122.3; p\u22640.01 at 300\n            mg) and in HAQ-DI (\u22120.47 to \u22120.57; p\u22640.05 at 300 mg). This was not the case for\n            achieving an ACR20 response (41% of patients on placebo vs 65% on 300 mg), but it was\n            for ACR50 (6% for placebo vs 45% on 300 mg).\u003C\/p\u003E\n         \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\/13\/8\/18\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Results of the Efficacy Endpoints\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1727014137\u0022 data-figure-caption=\u0022Results of the Efficacy Endpoints\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\/13\/8\/18\/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\/13\/8\/18\/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\/13\/8\/18\/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\/13393\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\u003EResults of the Efficacy Endpoints\u003C\/p\u003E\n            \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EACR20=American College of Rheumatology 20% improvement criteria; CRP=C-reactive\n               protein; DAS28=disability activity score in 28 joints; GA=general assessment;\n               HAQ-DI=Health Assessment Questionnaire-Disability Index; SJC=swollen joint count;\n               TJC=tender joint count.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from FP Vanhoutte, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n         \u003Cp id=\u0022p-9\u0022\u003EThe overall safety profile of GLPG0634 was favorable (Table 1). GLPG0634 was associated\n            with a limited decrease in absolute neutrophil count, no neutropenia, and no impact on\n            lymphocyte differentials. No increases in levels of low-density lipoprotein cholesterol\n            and no elevations in liver transaminases (alanine aminotransferase\/aspartate\n            transaminase) were observed. A modest improvement in hemoglobin was induced by\n            GLPG0634.\u003C\/p\u003E\n         \u003Cp id=\u0022p-10\u0022\u003EMost adverse events were mild and no serious adverse events were reported. No patient\n            discontinued due to adverse events.\u003C\/p\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EThese early clinical results demonstrated that selective inhibition of JAK1 by\n            once-daily dosing of GLPG0634 from 75 to 300 mg was efficacious and generally well\n            tolerated for 4 weeks\u0027 treatment of RA, concluded Dr. Vanhoutte. Larger, longer-term\n            studies in RA are being initiated to evaluate optimal doses for efficacy and safety.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 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\/13\/8\/18.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?nznsmp\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?nznsmp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}