{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T13:51:02Z","timestamp":1779112262802,"version":"3.51.4"},"reference-count":40,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T00:00:00Z","timestamp":1657152000000},"content-version":"unspecified","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/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":["bmj.com"],"crossmark-restriction":true},"short-container-title":["RMD Open"],"accepted":{"date-parts":[[2022,4,7]]},"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To assess apremilast\u2019s impact on patient quality of life (QoL) in active Beh\u00e7et\u2019s syndrome and correlations between improvement in patients\u2019 QoL and efficacy measures in the phase 3 RELIEF study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>QoL measures included Beh\u00e7et\u2019s Disease QoL (BDQoL), 36-Item Short-Form Health Survey V.2 (SF-36v2) Physical\/Mental Component Summary (PCS\/MCS) and eight subscale scores, focusing on Physical Functioning (PF). Pearson\u2019s correlation coefficients assessed relationships between efficacy endpoints (oral ulcer count, oral ulcer pain, Beh\u00e7et\u2019s Syndrome Activity Scale (BSAS), Beh\u00e7et\u2019s Disease Current Activity Form (BDCAF)) and QoL endpoints for apremilast at Week 12.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Apremilast (n=104) demonstrated significantly greater improvements versus placebo (n=103) in SF-36v2 PCS (3.1 vs 0.9), MCS (4.6 vs \u25000.7) and PF (2.9 vs 0.14), respectively (all p&lt;0.05). Mild correlations were observed in improvements of SF-36v2 measures (PCS, MCS, PF) with oral ulcer count (r=\u22120.11, PCS), and change in oral ulcer pain from baseline (r=\u22120.28, PCS; r=\u22120.10, PF) and BSAS (r=\u22120.38, PCS; r=\u22120.20, PF; r=\u22120.16, MCS). Correlations among BDCAF and SF-36v2 components and BDQoL were variable. BDQoL showed mild\/moderate correlations with SF-36v2 components (r=\u22120.18, PCS; r=\u22120.13, PF; r=\u22120.45, MCS).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Apremilast was associated with significant improvements in QoL measures of SF-36v2 PCS, MCS and PF and BDQoL in patients with Beh\u00e7et\u2019s syndrome. Correlations of improvement among QoL endpoints support the beneficial clinical effects of apremilast in Beh\u00e7et\u2019s syndrome.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02307513\">NCT02307513<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/rmdopen-2022-002235","type":"journal-article","created":{"date-parts":[[2022,7,7]],"date-time":"2022-07-07T12:16:24Z","timestamp":1657196184000},"page":"e002235","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Impact of apremilast on quality of life in Beh\u00e7et\u2019s syndrome: analysis of the phase 3 RELIEF study"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"nct02307513","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1952-1135","authenticated-orcid":false,"given":"G\u00fclen","family":"Hatemi","sequence":"first","affiliation":[{"name":"Cerrahpa\u015fa School of Medicine and Beh\u00e7et\u2019s Disease Research Center, Istanbul University, Istanbul, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alfred","family":"Mahr","sequence":"additional","affiliation":[{"name":"Cantonal Hospital St. Gallen, St. Gallen, Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mitsuhiro","family":"Takeno","sequence":"additional","affiliation":[{"name":"Nippon Medical School, Musashi Kosugi Hospital, Kawasaki, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Doyoung","family":"Kim","sequence":"additional","affiliation":[{"name":"Yonsei University College of Medicine and Severance Hospital, Seoul, South Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Melike","family":"Meliko\u011flu","sequence":"additional","affiliation":[{"name":"Cerrahpa\u015fa School of Medicine and Beh\u00e7et\u2019s Disease Research Center, Istanbul University, Istanbul, Turkey"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sue","family":"Cheng","sequence":"additional","affiliation":[{"name":"Amgen Inc, Thousand Oaks, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shannon","family":"McCue","sequence":"additional","affiliation":[{"name":"Celgene Corporation, Summit, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Paris","sequence":"additional","affiliation":[{"name":"Amgen Inc, Thousand Oaks, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mindy","family":"Chen","sequence":"additional","affiliation":[{"name":"Amgen Inc, Thousand Oaks, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7605-5759","authenticated-orcid":false,"given":"Yusuf","family":"Yazici","sequence":"additional","affiliation":[{"name":"New York University School of Medicine, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,7,7]]},"reference":[{"key":"2025090313501725000_8.2.e002235.1","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1038\/s41572-021-00301-1","article-title":"Beh\u00e7et syndrome","volume":"7","author":"Yazici","year":"2021","journal-title":"Nat Rev Dis Primers"},{"key":"2025090313501725000_8.2.e002235.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clindermatol.2013.01.002"},{"key":"2025090313501725000_8.2.e002235.3","doi-asserted-by":"publisher","DOI":"10.2165\/11641370-000000000-00000"},{"key":"2025090313501725000_8.2.e002235.4","doi-asserted-by":"crossref","DOI":"10.1038\/nrrheum.2018.3","article-title":"Beh\u00e7et syndrome: a contemporary view","volume":"14","author":"Yazici","year":"2018","journal-title":"Nat Rev Rheumatol"},{"key":"2025090313501725000_8.2.e002235.5","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2018-213225"},{"key":"2025090313501725000_8.2.e002235.6","doi-asserted-by":"crossref","first-page":"69","DOI":"10.1186\/s13075-017-1222-3","article-title":"Treatment of mucocutaneous manifestations in Beh\u00e7et's disease with anakinra: a pilot open-label study","volume":"19","author":"Grayson","year":"2017","journal-title":"Arthritis Res Ther"},{"key":"2025090313501725000_8.2.e002235.7","first-page":"1078","article-title":"Criteria for diagnosis of Beh\u00e7et's disease. 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