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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\u003EWhether a biologic response modifier or triple disease-modifying antirheumatic drug (DMARD) therapy should be the mainstay of treatment for patients with rheumatoid arthritis (RA) is a subject for debate. This article compares triple conventional DMARD therapy versus biologic agents for the treatment of RA.\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\u003EExclusive Article - For home page\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ERheumatoid Arthritis\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EWhether a biologic response modifier or triple disease-modifying antirheumatic drug (DMARD) therapy should be the mainstay of treatment for patients with rheumatoid arthritis (RA) is a subject for debate.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EJames R. O\u0027Dell, MD, University of Nebraska Medical Center, Omaha, Nebraska, USA, presented the opinion that favors triple conventional DMARD therapy. In emphasizing a treat-to-target strategy, he said that conventional DMARD therapy should be started before biologics as initial treatment for RA, and conventional DMARDs should be combined with existing methotrexate (MTX) before biologics are added.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDr. O\u0027Dell argued that treatment for RA should hinge on value, the three components of which are efficacy, toxicity, and cost. He first discussed the efficacy component of value, pointing to major investigator-initiated studies in support of synthetic DMARDs. Dr. O\u0027Dell supported his position using the TEAR study [Moreland LW et al. \u003Cem\u003EArthritis Rheum\u003C\/em\u003E 2012], in which there was no difference in the primary endpoint\u2014the disease activity score in 28 joints (DAS28) plus erythrocyte sedimentation rate at Weeks 48 and 102\u2014between patients randomized to triple therapy and those randomized to MTX plus etanercept.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EClinical outcomes between the two strategies as initial therapy were identical at 2 years in the BeST study [Goekoop-Ruiterman YP et al. \u003Cem\u003EAnn Intern Med\u003C\/em\u003E 2007], at which time \u0026lt;15% of patients who were started on conventional DMARD therapy required step-up to a biologic. In an observational study conducted in two Nordic hospitals [Sokka T et al. \u003Cem\u003EClin Exp Rheumatol\u003C\/em\u003E 2013], remission\/low disease activity was achieved at similar rates between therapy with combination conventional DMARDs and biologic drugs.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EIn examining the best strategy after MTX failure, Dr. O\u0027Dell cited the RACAT study [O\u0027Dell JR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013], in which triple DMARD therapy was noninferior to etanercept plus MTX on the DAS28 endpoint in RA patients who had active disease despite MTX therapy. Twenty-four month data from the Swefot study [van Vollenhoven RF et al. \u003Cem\u003ELancet\u003C\/em\u003E 2012] also demonstrated no convincing clinical difference between adding DMARDs or a biologic after initial MTX failure, although 12-month data favored the biologic (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E) [van Vollenhoven RF et al. \u003Cem\u003ELancet\u003C\/em\u003E 2009].\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\/13\/18\/10\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Swefot: Rates of Achieving Primary Outcome (EULAR Good Response) by Treatment\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-219725447\u0022 data-figure-caption=\u0022Swefot: Rates of Achieving Primary Outcome (EULAR Good Response) by Treatment\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\/18\/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\/13\/18\/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\/13\/18\/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\/13829\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-7\u0022 class=\u0022first-child\u0022\u003ESwefot: Rates of Achieving Primary Outcome (EULAR Good Response) by Treatment\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EEULAR=European League Against Rheumatism; Swefot=Swedish Farmacotherapy.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced from van Vollenhoven RF et al. Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. \u003Cem\u003ELancet\u003C\/em\u003E 2009;374(9688):459\u2013466. With permission from Elsevier.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-8\u0022\u003EIf treatment is to target, the choice of agent does not matter, said Dr. O\u0027Dell.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003ERonald F. van Vollenhoven, MD, PhD, Karolinska Institute, Stockholm, Sweden, countered that biologic agents have revolutionized the treatment of RA and are clearly the more effective choice when used with MTX. Biologic agents are not only superior to conventional agents on the endpoint of disease activity, they act more quickly than conventional agents and are significantly superior to conventional agents on radiographic endpoints, he argued.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EFinnish investigators, in their own investigator-initiated trial, Neo-RACo, found that the 2-year remission rate improved from 53% to 66% when patients with early active RA were treated with infliximab added to conventional intensified DMARDs compared with intensified treatment alone for the initial 6 months [Leirisalo-Repo M et al. \u003Cem\u003EAnn Rheum Dis\u003C\/em\u003E 2013].\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EAddition of adalimumab to MTX and intra-articular steroids improved several endpoints including the DAS28-CRP, remission, function, and quality of life in the investigator-initiated OPERA study [H\u00f8rslev-Petersen K et al. \u003Cem\u003EAnn Rheum Dis\u003C\/em\u003E 2013]. The additional improvement with adalimumab was \u223c25% on these outcomes (\u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E).\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\/13830\/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\/13830\/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\/13830\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-12\u0022 class=\u0022first-child\u0022\u003EOPERA: Outcomes by Treatment\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-15\u0022\u003EIn the Swefot study, the rate of good responses was better with the addition of infliximab than with the addition of sulfasalazine and hydroxychloroquine after MTX failure at both 12 months (39% vs 25%) [van Vollenhoven RF et al. \u003Cem\u003ELancet\u003C\/em\u003E 2009] and 24 months (43% vs 31%) [van Vollenhoven RF et al. \u003Cem\u003ELancet\u003C\/em\u003E 2012]. The difference at 24 months failed to achieve significance because the high number of dropouts left the study underpowered. Radiographic progression was significantly less in the biologic arm at 24 months, said Prof. van Vollenhoven.\u003C\/p\u003E\u003Cp id=\u0022p-16\u0022\u003EResponse is faster with biologics than with conventional DMARDs, he continued. RACAT showed a trend toward a more rapid response in patients assigned to etanercept-MTX compared with conventional combinations of DMARDs [O\u0027Dell JR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013]. It also demonstrated strong trends that favored etanercept in the change in DAS28 by 24 weeks, the percentage who achieved a DAS28 \u22643.2 and \u22642.6 (indicative of remission) at 24 weeks, American College of Rheumatology 50% improvement response criteria (ACR50) response at 24 weeks, and ACR70 response at 48 weeks, with a significant improvement (p=0.001) in the percentage who achieved an ACR70 response at 24 weeks. Radiographic outcomes were also superior with anti-tumor necrosis factor (TNF) therapy.\u003C\/p\u003E\u003Cp id=\u0022p-17\u0022\u003EIn his rebuttal, Dr. O\u0027Dell said that although the TEAR trial did indeed show a faster response to biologics in patients with poor prognosis, patients on triple therapy did as well as those on biologics from Week 36 to Year 2 [Moreland LW et al. \u003Cem\u003EArthritis Rheum\u003C\/em\u003E 2012]. Similar results were obtained in the BeST trial of patients with early RA [Goekoop-Ruiterman YP et al. \u003Cem\u003EAnn Intern Med\u003C\/em\u003E 2007]. In RACAT, patients were permitted to switch therapies with insufficient response to their original therapy, but by the end of the trial, outcomes were identical regardless of initial or secondary therapy [O\u0027Dell JR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013].\u003C\/p\u003E\u003Cp id=\u0022p-18\u0022\u003EThe small radiographic differences in favor of biologics, although statistically significant, are not clinically significant, said Dr. O\u0027Dell. The advantage is typically in the range of one-half point on the 488-point total Sharp score (TSS). A 22-point difference would be required to detect a clinical difference on the TSS, he said.\u003C\/p\u003E\u003Cp id=\u0022p-19\u0022\u003EIn terms of toxicity, anti-TNF therapy was associated with double the rate of serious infections and triple the rate of malignancies compared with placebo in a meta-analysis [Bongartz T et al. \u003Cem\u003EJAMA\u003C\/em\u003E 2006].\u003C\/p\u003E\u003Cp id=\u0022p-20\u0022\u003EBiologics, as a class, are much better tolerated than conventional agents, said Prof. van Vollenhoven. He pointed to the higher rates of gastrointestinal and other complaints with conventional therapies [O\u0027Dell JR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2013]. In RACAT, the withdrawal rate due to adverse events was more than double in patients assigned to conventional agents compared with patients assigned to biologics. Statistically significant higher rates of cardiovascular events and serious respiratory\/thoracic\/mediastinal events were also recorded among the patients assigned to conventional DMARDs.\u003C\/p\u003E\u003Cp id=\u0022p-21\u0022\u003EDr. O\u0027Dell concluded with cost to support the position of triple DMARD therapy. In the Nordic hospitals study, despite equal outcomes, drug costs were nearly twice as high in the biologics group [Sokka T et al. \u003Cem\u003EClin Exp Rheumatol\u003C\/em\u003E 2013]. In TEAR, every quality-adjusted life-year gained in patients treated with biologics costs $837,100 [Jalal H et al. ACR 2013 (abstr 2646)].\u003C\/p\u003E\u003Cp id=\u0022p-22\u0022\u003EWhile the economic considerations are legitimate, biologic therapy is the most effective treatment for RA today, said Prof. van Vollenhoven.\u003C\/p\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\/18\/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?nzo5tp\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?nzo5tp\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?nzo5tp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}