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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\u003EApremilast, an oral phosphodiesterase 4 inhibitor that works intracellularly to regulate inflammatory mediators, has been tested in the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) program, which consists of 2 trials: ESTEEM 1 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01194219\u0026amp;atom=%2Fspmdc%2F14%2F37%2F15.atom\u0022\u003ENCT01194219\u003C\/a\u003E] and ESTEEM 2 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01232283\u0026amp;atom=%2Fspmdc%2F14%2F37%2F15.atom\u0022\u003ENCT01232283\u003C\/a\u003E]. This article presents the 52-week results of the ESTEEM 2 trial.\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\u003EApremilast, an oral phosphodiesterase 4 inhibitor that works intracellularly to regulate inflammatory mediators, has been tested in the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) program, which consists of 2 trials: ESTEEM 1 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01194219\u0026amp;atom=%2Fspmdc%2F14%2F37%2F15.atom\u0022\u003ENCT01194219\u003C\/a\u003E] and ESTEEM 2 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01232283\u0026amp;atom=%2Fspmdc%2F14%2F37%2F15.atom\u0022\u003ENCT01232283\u003C\/a\u003E]. Carle Paul, MD, Toulouse University, Toulouse, France, presented the 52-week results of the ESTEEM 2 trial.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EPatients with moderate-to-severe plaque psoriasis, defined as Psoriasis Area and Severity Index (PASI) \u2265 12, body surface area \u2265 10%, and Static Physician\u0027s Global Assessment (sPGA) \u2265 3, were randomized 2:1 to treatment with apremilast 30 mg BID (n = 274) or placebo (n = 137). At week 16, placebo patients switched to apremilast, and all patients received apremilast through week 32. At week 32, patients receiving apremilast from baseline who achieved PASI-50 response were rerandomized to continue apremilast or receive placebo. On loss of 50% of PASI improvement achieved at week 32, patients who had been rerandomized to placebo were switched back to apremilast. The primary end point was PASI-75 at week 16.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe included patients were aged \u2265 18 years and had moderate-to-severe chronic plaque psoriasis for \u2265 12 months. The full analysis set included 411 patients. At week 16, significantly more patients treated with apremilast achieved PASI-75 (28.8% vs 5.8%; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001) when compared with placebo. Significant findings were also noted in PASI-50 (55.5% vs 19.7%; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001) and sPGA 0 or 1 (20.4% vs 4.4%; \u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001; \u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\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\/14\/37\/15\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022PASI-75, PASI-50, and sPGA Responses at Week 16\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-835538393\u0022 data-figure-caption=\u0022PASI-75, PASI-50, and sPGA Responses at Week 16\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\/14\/37\/15\/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\/14\/37\/15\/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\/14\/37\/15\/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\/12113\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-5\u0022 class=\u0022first-child\u0022\u003EPASI-75, PASI-50, and sPGA Responses at Week 16\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003EData are the full analysis set, last observation carried forward (N = 411). PASI, Psoriasis Area and Severity Index; sPGA, Static Physician\u0027s Global Assessment.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003E*\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001 vs placebo; sPGA score of 0 (clear) or 1 (almost clear) with \u22652-point reduction from baseline.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EReproduced with permission from C Paul, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-6\u0022\u003EPASI responses generally were maintained through week 32 (\u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F2\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\/14\/37\/15\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022PASI-50, PASI-75, and PASI-90 Throughout 32 Weeks in Patients Receiving Apremilast From Baselinea             \u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-835538393\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;PASI-50, PASI-75, and PASI-90 Throughout 32 Weeks in Patients Receiving Apremilast From Baseline\u0026amp;lt;sup\u0026amp;gt;a\u0026amp;lt;\/sup\u0026amp;gt;             \u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/37\/15\/F2.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\/14\/37\/15\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\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\/14\/37\/15\/F2.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\/12114\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 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-7\u0022 class=\u0022first-child\u0022\u003EPASI-50, PASI-75, and PASI-90 Throughout 32 Weeks in Patients Receiving Apremilast From Baseline\u003Csup\u003Ea\u003C\/sup\u003E\n            \u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-4\u0022\u003EPASI, Psoriasis Area and Severity Index.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-5\u0022\u003E\n            \u003Csup\u003Ea\u003C\/sup\u003EData using nonresponder imputation at each time point.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-6\u0022\u003EReproduced with permission from C Paul, MD.\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\u003EAmong patients randomized at baseline to apremilast, the mean percent change from baseline PASI at week 52 was \u221245.7% in week 32 PASI-50 nonresponders and \u221274.4% in week 32 PASI-50 responders. Among patients randomized at baseline to placebo and switched to apremilast at week 16, the mean percent change from baseline PASI at week 52 was \u221224.7% in week 32 PASI-50 nonresponders and \u221271.8% in week 32 PASI-50 responders.\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EThe mean improvement in PASI generally remained stable from week 32 (77%) to 52 (74%) in patients with PASI-50 rerandomized to apremilast at week 32. The median time to loss of 50% of PASI improvement at week 32 was 12.4 weeks for patients rerandomized to placebo. Approximately 66% of patients rerandomized to placebo regained PASI-50 response after reinitiation of treatment with apremilast (duration of retreatment ranged from 2.6 to 18.3 weeks).\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EMost adverse events (AEs) were mild or moderate and did not lead to discontinuation. The serious AE rate was low and comparable among treatment arms. AEs occurring in \u2265 5% of patients exposed to apremilast from weeks 0 to 52 were nausea (16.6%), diarrhea (14.5%), nasopharyngitis (14.5%), upper respiratory tract infection (9.2%), tension headache (7.6%), vomiting (6.3%), headache (5.8%), and back pain (5.3%). Changes in laboratory parameters were transient with no trends observed.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003EApremilast 30 mg BID significantly reduced (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001) the severity of moderate-to-severe psoriasis throughout 16 weeks, with responses generally maintained to 52 weeks. The results of ESTEEM 2 confirm the efficacy of apremilast in patients with psoriasis, as reported in ESTEEM 1. Apremilast was generally well tolerated up to 52 weeks. Prof Paul concluded that apremilast represents a novel therapeutic option for patients with moderate-to-severe plaque psoriasis.\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\/15.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?nzop9p\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?nzop9p\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}