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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\u003EAtopic dermatitis (AD) is a common, chronic skin condition induced by a type 2 helper T cell-mediated response to various environmental antigens. These cells release cytokines that promote occurrence and recurrence of AD. This article reviews safety and efficacy results from the phase 2b Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01859988\u0026amp;atom=%2Fspmdc%2F14%2F37%2F13.1.atom\u0022\u003ENCT01859988\u003C\/a\u003E].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ESkin Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDermatology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ESkin Diseases\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDermatology\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EDermatology Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EMarius Ardeleanu, MD, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA, reviewed safety and efficacy results from the phase 2b Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01859988\u0026amp;atom=%2Fspmdc%2F14%2F37%2F13.1.atom\u0022\u003ENCT01859988\u003C\/a\u003E].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EAtopic dermatitis (AD) is a common, chronic skin condition induced by a type 2 helper (Th2) T cell-mediated response to various environmental antigens. These cells release cytokines that promote occurrence and recurrence of AD. Two Th2 cytokines thought likely to be involved in the pathogenesis of AD are interleukin (IL)-4 and IL-13 [Lebwohl MG et al. \u003Cem\u003EJ Clin Aesthet Dermatol\u003C\/em\u003E. 2013]. Dupilumab is a monoclonal antibody that targets the IL-4 receptor \u03b1 subunit, blocking intracellular signaling of both IL-4 and IL-13. Data from early clinical trials have suggested that dupilumab is safe and efficacious for adults with moderate-to-severe AD [Beck LA et al. \u003Cem\u003EN Engl J Med.\u003C\/em\u003E 2014].\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe multicenter, international, double-blind, placebo-controlled, randomized, dose-ranging study was designed to test the safety and efficacy of subcutaneous injections of dupilumab in 380 adults with chronic moderate-to-severe AD poorly controlled on current topical medications. Patients were divided into 5 treatment groups. On day 1 of the 16-week study, patients received a loading dose of either 400 or 600 mg. The 5 groups of patients then received dupilumab in doses ranging from 100 mg every 4 weeks to 300 mg every week. All groups were followed for an additional 16 weeks.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EThe primary end point was percent change in the Eczema Area and Severity Index (EASI) from baseline to week 16. Key secondary end points included the proportion of patients who achieved a reduction of 50%, 75%, or 90% in the EASI (EASI-50\/75\/90); changes in various measurements of pruritus and skin condition; and safety.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EAll patients had chronic AD for \u2265 3 years (EASI \u2265 16), with a documented inadequate response to topical treatments for at least 6 months prior to the screening visit. Patients who had received prior treatment with dupilumab, had an active infection, or had used topical medications for AD within 1 week of baseline were excluded from the trial. Mean patient age was 37 years, and mean duration of time with AD was 31 years.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EPatients who received any regimen of dupilumab achieved a significantly greater mean percent change in the EASI compared with placebo (all \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001); the 300-mg dose given every week produced the greatest percent change. According to Dr Ardeleanu, most of the response was evident within 4 to 6 weeks.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003ERelative to the secondary end points, almost every dose regimen was statistically more likely to achieve EASI-50\/75\/90 throughout 16 weeks compared with placebo (\u003Cem\u003EP\u003C\/em\u003E range, \u0026lt; .05 to \u0026lt; .0001); the only exception was the 100-mg dose once weekly, which did not reach statistical significance for EASI-50. Although patients who took any dose of dupilumab achieved an improved Investigator\u0027s Global Assessment response as well as self-reported reductions in pruritus, the 300-mg weekly and every 2-week doses showed the most consistent benefits among all the outcomes.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe most common adverse events were nasopharyngitis, headache, and injection site reactions, all of which were higher in the dupilumab groups. There were no dose-limiting toxicities. Based on these results, Dr Ardeleanu noted that the 2 highest dose regimens will be further tested in a phase 3 trial and that a maintenance study will be done to test whether lower doses of dupilumab can maintain the improvements sustained with higher doses.\u003C\/p\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\/37\/13.1.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?nzop1d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}