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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003EResults from the Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg\/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis trial [ADACTA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01119859\u0026amp;atom=%2Fspmdc%2F12%2F9%2F10.atom\u0022\u003ENCT01119859\u003C\/a\u003E], suggest that tocilizumab monotherapy may be more effective than adalimumab monotherapy reducing the signs and symptoms of rheumatoid arthritis.\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\u003Cp id=\u0022p-2\u0022\u003EData from several registries and a United States health insurance claims database have shown that approximately one-third of rheumatoid arthritis (RA) patients are being treated with biologics as monotherapy [Yazici Y et al. \u003Cem\u003EBull NYU Hosp Jt Dis\u003C\/em\u003E 2008; Lee SJ et al. \u003Cem\u003EJ Rheumatol\u003C\/em\u003E 2009], but there have been no head-to-head studies to assist in the choice of monotherapy for these patients. Results from the Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg\/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis trial [ADACTA; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01119859\u0026amp;atom=%2Fspmdc%2F12%2F9%2F10.atom\u0022\u003ENCT01119859\u003C\/a\u003E], presented by Cem Gabay, MD, University Hospitals, Geneva, Switzerland, suggest that tocilizumab monotherapy may be more effective than adalimumab monotherapy reducing the signs and symptoms of RA.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe ADACTA trial was an international, multicenter, randomized, double-blind, 24-week superiority trial that compared tocilizumab with adalimumab monotherapy in patients with RA. Patients were required to have an RA diagnosis of \u22656 months and a Disease Activity Score (DAS) score \u0026gt;5.1 and to be methotrexate-intolerant or judged inappropriate for continued treatment with methotrexate. Patients with prior treatment with a biologic agent were excluded. The primary study endpoint was mean change from baseline in the DAS28 at Week 24. Key secondary endpoints included efficacy at Week 24, based on the proportions of patients who achieved DAS28 remission (\u0026lt;2.6) and low disease activity (\u22643.2), ACR 20\/50\/70 responses, and ACR\/EULAR remission. Safety was assessed using adverse events (AEs) and laboratory parameters. Clinical Disease Activity Index (CDAI) responses were assessed as a \u003Cem\u003Epost hoc\u003C\/em\u003E analysis.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EStudy participants, aged 53 to 54 years and mainly women (82% in the adalimumab arm; 79% in the tocilizumab arm), had active disease (DAS 6.7 to 6.8; Health Assessment Questionnaire score 1.6 to 1.7) and a disease duration of 6.3 to 7.3 years. Subjects were randomized to intravenous tocilizumab 8 mg\/kg every 4 weeks plus subcutaneous placebo (n=163) or adalimumab 40 mg subcutaneously every 2 weeks plus intravenous placebo (n=163). Patients who did not achieve at least a 20% improvement from baseline in swollen and tender joint count at Week 16 or later could escape to weekly subcutaneous injections of adalimumab\/placebo.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EAt Week 24, the change from baseline in DAS28 was \u22123.3 for the tocilizumab group versus \u22121.8 for subjects who received adalimumab (difference, 1.5; 95% CI for difference, \u22121.8 to \u22121.1; p\u0026lt;0.0001). Differences were observed, beginning at Week 8 (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). Significantly (p\u0026lt;0.0001) more subjects in the tocilizumab group also achieved the secondary endpoints of remission and low disease activity compared with those who received adalimumab (39.9% versus 10.5% and 51.5% versus 19.8%, respectively). ACR20\/50\/70 responses were also significantly (p\u0026lt;0.01) better among the tocilizumab subjects (65.0%, 47.2%, 32.5%) compared with subjects who received adalimumab (49.4%, 27.8%, 17.9%). In the \u003Cem\u003Epost hoc\u003C\/em\u003E analysis for CDAI response, 47.9% of tocilizumab versus 29.0% of adalimumab subjects (p=0.0003) were considered to be in remission or have low disease activity (CDAI score \u22650 to \u226410).\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\/9\/10\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022DAS28: Mean (\u0026#xB1;SE) Over Time.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-2093728950\u0022 data-figure-caption=\u0022DAS28: Mean (\u0026#xB1;SE) Over Time.\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\/9\/10\/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\/9\/10\/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\/9\/10\/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\/14204\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-6\u0022 class=\u0022first-child\u0022\u003EDAS28: Mean (\u00b1SE) Over Time.\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003ETJC=tender joint count; SJC=swollen joint count; TCZ=tocilizumab; ADA=adalimumab; LOCF used for TJC and SJC; ESR and Patient\u0027s Global Assessment of Disease Activity VAS; If ESR=0 then ESR=1 is substituted into the DAS28 calculation to enable a non-missing DAS28.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from C. Gabay, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-7\u0022\u003EThe incidence of AEs was similar (82.1% in the tocilizumab arm and 82.7% in the adalimumab arm). Serious AEs and serious infections were also similar (tocilizumab: 11.7%, 3.1%; adalimumab: 9.9%, 3.1%). Changes in transaminase, low-density lipoprotein elevations, and neutrophil reductions occurred in both arms, with the proportion of patients with abnormal values higher in the tocilizumab arm. There were 2 deaths in the tocilizumab arm; 1 from sudden death that was considered to possibly be related to the study drug and 1 from illicit drug overdose that was not considered to be related.\u003C\/p\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\/9\/10.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?nznfwd\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?nznfwd\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}