{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T04:45:11Z","timestamp":1793335511408,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2016,12,19]],"date-time":"2016-12-19T00:00:00Z","timestamp":1482105600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006436","name":"Celgene","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006436","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2017,3]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Apremilast, an oral, small\u2010molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate\u2010to\u2010severe psoriasis.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n \n Evaluate efficacy and safety of apremilast vs. placebo in biologic\u2010naive patients with moderate\u2010to\u2010severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase\n III<\/jats:styled-content>\n b, randomized, double\u2010blind, placebo\u2010controlled study (\n NCT<\/jats:styled-content>\n 01690299).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Two hundred and fifty patients were randomized to placebo (\n n\u00a0<\/jats:italic>\n =\n \u00a0<\/jats:italic>\n 84), apremilast 30\u00a0mg\n BID<\/jats:styled-content>\n (\n n\u00a0<\/jats:italic>\n =\n \u00a0<\/jats:italic>\n 83) or etanercept 50\u00a0mg\n QW<\/jats:styled-content>\n (\n n\u00a0<\/jats:italic>\n =\n \u00a0<\/jats:italic>\n 83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104. The primary efficacy endpoint was achievement of\n PASI<\/jats:styled-content>\n \u201075 at Week 16 with apremilast vs. placebo. Secondary endpoints included achievement of\n PASI<\/jats:styled-content>\n \u201075 at Week 16 with etanercept vs. placebo and improvements in other clinical endpoints vs. placebo at Week 16. Outcomes were assessed through Week 52. This study was not designed for apremilast vs. etanercept comparisons.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n At Week 16,\n PASI<\/jats:styled-content>\n \u201075 achievement was greater with apremilast (39.8%) vs. placebo (11.9%;\n P\u00a0<\/jats:italic>\n <\n \u00a0<\/jats:italic>\n 0.0001); 48.2% of patients achieved\n PASI<\/jats:styled-content>\n \u201075 with etanercept (\n P\u00a0<\/jats:italic>\n <\n \u00a0<\/jats:italic>\n 0.0001 vs. placebo).\n PASI<\/jats:styled-content>\n \u201075 response was maintained in 47.3% (apremilast\/apremilast), 49.4% (etanercept\/apremilast) and 47.9% (placebo\/apremilast) of patients at Week 52. Most common adverse events (\u22655%) with apremilast, including nausea, diarrhoea, upper respiratory tract infection, nasopharyngitis, tension headache and headache, were mild or moderate in severity; diarrhoea and nausea generally resolved in the first month. No new safety or tolerability issues were observed through Week 52 with apremilast.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Apremilast demonstrated significant efficacy vs. placebo at Week 16 in biologic\u2010naive patients with psoriasis, which was sustained over 52\u00a0weeks, and demonstrated safety consistent with the known safety profile of apremilast. Switching from etanercept to apremilast did not result in any new or clinically significant safety findings, and efficacy was maintained with apremilast through Week 52.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/jdv.14015","type":"journal-article","created":{"date-parts":[[2016,10,21]],"date-time":"2016-10-21T13:54:49Z","timestamp":1477058089000},"page":"507-517","source":"Crossref","is-referenced-by-count":185,"title":["The efficacy and safety of apremilast, etanercept and placebo in patients with moderate\u2010to\u2010severe plaque psoriasis: 52\u2010week results from a phase IIIb, randomized, placebo\u2010controlled trial (LIBERATE)"],"prefix":"10.1111","volume":"31","author":[{"given":"K.","family":"Reich","sequence":"first","affiliation":[{"name":"SCIderm Research Institute and Dermatologikum Hamburg Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Gooderham","sequence":"additional","affiliation":[{"name":"SKiN Centre for Dermatology and Probity Medical Research Peterborough ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Green","sequence":"additional","affiliation":[{"name":"George Washington University School of Medicine Washington DC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Bewley","sequence":"additional","affiliation":[{"name":"Whipps Cross University Hospital & the Royal London Hospital London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Z.","family":"Zhang","sequence":"additional","affiliation":[{"name":"Celgene Corporation Summit NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I.","family":"Khanskaya","sequence":"additional","affiliation":[{"name":"Celgene Corporation Summit NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.M.","family":"Day","sequence":"additional","affiliation":[{"name":"Celgene Corporation Summit NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Goncalves","sequence":"additional","affiliation":[{"name":"Celgene Corporation Summit NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Shah","sequence":"additional","affiliation":[{"name":"Celgene Corporation Summit NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"V.","family":"Piguet","sequence":"additional","affiliation":[{"name":"Cardiff University and University Hospital of Wales Wales UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Soung","sequence":"additional","affiliation":[{"name":"Southern California Dermatology Santa Ana CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,12,19]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1468-3083.2011.04410.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-4632.2011.05154.x"},{"key":"e_1_2_8_4_1","first-page":"27","article-title":"Emerging treatment options for psoriasis","volume":"4","author":"Taheri A","year":"2014","journal-title":"Psoriasis Targets Ther"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bcp.2012.01.001"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cellsig.2014.05.014"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13075-015-0771-6"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2013-205056"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.3899\/jrheum.140647"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-207963"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2015.03.049"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.14164"},{"issue":"62","key":"e_1_2_8_13_1","first-page":"50","article-title":"Clinical meaning of change in dermatology life quality index scores [abstract P\u201059]","volume":"147","author":"Khilji FA","year":"2002","journal-title":"Br J Dermatol"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1159\/000365390"},{"key":"e_1_2_8_15_1","first-page":"609","article-title":"Determination of minimum clinically important difference (MCID) of visual analogue scale (VAS): in which direction should we proceed? 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