{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T16:02:54Z","timestamp":1787414574057,"version":"build-2736575974"},"reference-count":13,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2021,8,17]],"date-time":"2021-08-17T00:00:00Z","timestamp":1629158400000},"content-version":"vor","delay-in-days":5,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Celgene. Amgen Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,2,28]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>Apremilast efficacy and safety was assessed in a prespecified subgroup of Japanese patients with oral ulcers associated with Beh\u00e7et\u2019s syndrome from a Phase 3 randomized, placebo-controlled, double-blind study of apremilast (RELIEF).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The primary end point was area under the curve for number of oral ulcers during the 12-week placebo-controlled phase (AUCWk0\u201312). Key secondary end points were change from baseline in oral ulcer pain, complete oral ulcer resolution, and measures of disease activity and quality of life (QoL).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Thirty-nine Japanese patients were randomised (apremilast 30\u2009mg BID: n\u2009=\u200919; placebo: n\u2009=\u200920). Improvements at Week 12 were observed for apremilast vs. placebo in AUCWk0\u201312 for the number of oral ulcers (115.9 vs. 253.3; nominal P\u2009=\u20090.0168); 57.9% vs. 25.0% achieved complete oral ulcer resolution, 47.4% vs. 0.0% achieved oral ulcer resolution by Week 6 and maintained oral ulcer-free status for \u22656 additional weeks; mean change from baseline in BSAS was \u221210.5 vs. 0.5. Favourable effects were observed for apremilast vs. placebo in other secondary end points, including QoL. Clinical benefits were sustained over 28\u2009weeks of continued apremilast treatment. Adverse events were consistent with apremilast\u2019s known safety profile.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Apremilast reduced the number of oral ulcers and overall disease activity in this Japanese subgroup with Beh\u00e7et\u2019s syndrome.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/mr\/roab008","type":"journal-article","created":{"date-parts":[[2021,12,11]],"date-time":"2021-12-11T14:05:21Z","timestamp":1639231521000},"page":"413-421","source":"Crossref","is-referenced-by-count":16,"title":["Apremilast in a Japanese subgroup with Beh\u00e7et\u2019s syndrome: Results from a Phase 3, randomised, double-blind, placebo-controlled study"],"prefix":"10.1093","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9212-7046","authenticated-orcid":false,"given":"Mitsuhiro","family":"Takeno","sequence":"first","affiliation":[{"name":"Department of Allergy and Rheumatology, Nippon Medical School, Musashi Kosugi Hospital, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Dobashi","sequence":"additional","affiliation":[{"name":"Division of Hematology, Rheumatology and Respiratory Medicine, Department of Internal Medicine, Faculty of Medicine, Kagawa University, Kagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0807-7139","authenticated-orcid":false,"given":"Yoshiya","family":"Tanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hajime","family":"Kono","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shouji","family":"Sugii","sequence":"additional","affiliation":[{"name":"Department of Rheumatic Diseases, Tokyo Metropolitan Matsuzawa Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitsumasa","family":"Kishimoto","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Rheumatology, Kyorin University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue","family":"Cheng","sequence":"additional","affiliation":[{"name":"Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shannon","family":"McCue","sequence":"additional","affiliation":[{"name":"Celgene Corporation, Summit, NJ, USA"},{"name":"The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Paris","sequence":"additional","affiliation":[{"name":"Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mindy","family":"Chen","sequence":"additional","affiliation":[{"name":"Amgen Inc., Thousand Oaks, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiaki","family":"Ishigatsubo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Clinical Immunology, Yokohama City University Graduate School of Medicine, Yokohama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,8,12]]},"reference":[{"key":"2022030105113729400_R1","article-title":"Clinical and pathological manifestations with differential diagnosis in Beh\u00e7et\u2019s disease","volume":"2012","author":"Kokturk","year":"2012","journal-title":"Patholog Res Int"},{"key":"2022030105113729400_R2","doi-asserted-by":"crossref","first-page":"352","DOI":"10.1016\/j.clindermatol.2013.01.002","article-title":"Beh\u00e7et\u2019s syndrome: facts and 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and psoriatic arthritis","volume":"83","author":"Schafer","year":"2012","journal-title":"Biochem Pharmacol"},{"key":"2022030105113729400_R10","doi-asserted-by":"publisher","DOI":"10.1155\/2015\/906349.","article-title":"The pharmacodynamic impact of apremilast, an oral phosphodiesterase 4 inhibitor, on circulating levels of inflammatory biomarkers in patients with psoriatic arthritis: substudy results from a phase III, randomized, placebo-controlled trial (PALACE 1)","volume":"2015","author":"Schafer","year":"2015","journal-title":"J Immunol Res"},{"key":"2022030105113729400_R11","doi-asserted-by":"crossref","first-page":"842","DOI":"10.1111\/j.1476-5381.2009.00559.x","article-title":"Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis","volume":"159","author":"Schafer","year":"2010","journal-title":"Br J 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