{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T05:01:50Z","timestamp":1789189310615,"version":"build-2803163510"},"reference-count":30,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T00:00:00Z","timestamp":1764115200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,11,26]],"date-time":"2025-11-26T00:00:00Z","timestamp":1764115200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100002429","name":"Amgen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002429","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2026,6]]},"abstract":"Abstract<\/jats:title>\n \n Background<\/jats:title>\n Palmoplantar pustulosis (PPP) is a difficult\u2010to\u2010treat chronic dermatitis with limited treatment options.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n To report results from a Phase 3 study of apremilast in patients with moderate to severe PPP (NCT05174065).<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n In this randomized, placebo\u2010controlled, double\u2010blind, confirmatory study, Japanese adults with PPP Area and Severity Index (PPPASI) total score \u226512, PPPASI pustules\/vesicles severity score\u2009\u22652 and inadequate response to topicals were randomly assigned (1:1) to apremilast or placebo for 16\u2009weeks, followed by an active treatment phase where all patients received apremilast through Week 52. The primary endpoint was a \u226550% reduction in PPPASI total score (PPPASI\u201050) at Week 16, evaluated in all randomized patients. Safety outcomes were assessed in all patients who received \u22651 dose of the study drug.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Between March 8, 2022 to April 28, 2023, 176 patients (141 [80%] women, 35 [20%] men) were randomly assigned to apremilast (\n n<\/jats:italic>\n \u2009=\u200988 [50%]) or placebo (\n n<\/jats:italic>\n \u2009=\u200988 [50%]). Mean (SD) PPPASI total score at baseline was 22.1 (8.1) in the apremilast group and 22.0 (8.4) in the placebo group. A significantly greater proportion of patients achieved PPPASI\u201050 at Week 16 with apremilast versus placebo (60 of 88 [68%] vs. 31 of 88 [35%]; treatment difference: 32.6% [95% CI: 18.7, 46.5],\n p<\/jats:italic>\n \u2009<\u20090.0001). Improvements were maintained through Week 52. The most common adverse events (\u226510% of patients) during the double\u2010blind phase in patients receiving apremilast were diarrhea (placebo:\n n<\/jats:italic>\n \u2009=\u20093 [3%]; apremilast:\n n<\/jats:italic>\n \u2009=\u200917 [19%]), feces soft (placebo:\n n<\/jats:italic>\n \u2009=\u20091 [1%]; apremilast:\n n<\/jats:italic>\n \u2009=\u200915 [17%]), headache (placebo:\n n<\/jats:italic>\n \u2009=\u20092 [2%]; apremilast:\n n<\/jats:italic>\n \u2009=\u200910 [11%]) and nausea (placebo:\n n<\/jats:italic>\n \u2009=\u20091 [1%]; apremilast:\n n<\/jats:italic>\n \u2009=\u200910 [11%]). There were no events of depression or fatal adverse events.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n In this Phase 3 trial, apremilast was effective in Japanese patients with moderate to severe PPP. Adverse events were consistent with the known safety profile of apremilast.<\/jats:p>\n \n ClinicalTrials.gov<\/jats:ext-link>\n : NCT05174065.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/jdv.70166","type":"journal-article","created":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T01:37:13Z","timestamp":1764207433000},"page":"994-1004","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Apremilast in Japanese patients with palmoplantar pustulosis: A\u00a0randomized, Phase 3 trial"],"prefix":"10.1111","volume":"40","author":[{"given":"Tadashi","family":"Terui","sequence":"first","affiliation":[{"name":"Nihon University School of Medicine Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9526-1259","authenticated-orcid":false,"given":"Yukari","family":"Okubo","sequence":"additional","affiliation":[{"name":"Tokyo Medical University Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satomi","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Seibo International Catholic Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8372-3754","authenticated-orcid":false,"given":"Akimichi","family":"Morita","sequence":"additional","affiliation":[{"name":"Nagoya City University Nagoya City Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Imafuku","sequence":"additional","affiliation":[{"name":"Fukuoka University Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yayoi","family":"Tada","sequence":"additional","affiliation":[{"name":"Teikyo University Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masatoshi","family":"Abe","sequence":"additional","affiliation":[{"name":"Sapporo Skin Clinic Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8394-2057","authenticated-orcid":false,"given":"Bruce","family":"Strober","sequence":"additional","affiliation":[{"name":"Yale University New Haven Connecticut USA"},{"name":"Central Connecticut Dermatology Research Cromwell Connecticut USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melinda","family":"Gooderham","sequence":"additional","affiliation":[{"name":"SKiN Centre for Dermatology Peterborough Ontario Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wendy","family":"Zhang","sequence":"additional","affiliation":[{"name":"Amgen Inc. 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