{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T14:48:38Z","timestamp":1787496518459,"version":"build-2736575974"},"reference-count":15,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,12,30]],"date-time":"2025-12-30T00:00:00Z","timestamp":1767052800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,12,30]],"date-time":"2025-12-30T00:00:00Z","timestamp":1767052800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100008349","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008349","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Dermatology"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Generalized pustular psoriasis (GPP) is a heterogeneous, systemic neutrophilic inflammatory disease, characterized by chronic symptoms and recurrent flares, which can be potentially life\u2010threatening. Spesolimab, an interleukin\u201036 receptor antagonist, has been approved to treat GPP flares in many countries including Japan. An expanded access program (EAP) in Japan provided early access to spesolimab for patients aged 18\u201375\u2009years unable to participate in a clinical trial with no other treatment options. Patients received a single dose of 900\u2009mg intravenous spesolimab for flare treatment, with an optional second dose after 1\u2009week if symptoms persisted. Safety was monitored for 16\u2009weeks post\u2010treatment. Eleven patients (54.5% female; 51\u2009years mean age; 26.7\u2009kg\/m\n                    <jats:sup>2<\/jats:sup>\n                    mean body mass index) received 23 doses of intravenous spesolimab. Nine patients (81.8%) were diagnosed with GPP for &gt;\u20095\u2009years. Ten patients (90.9%) had \u2265\u20091 baseline medical condition. All patients used \u2265\u20091 concomitant medication prior to or during the spesolimab treatment period, most commonly immunosuppressants and non\u2010steroidal anti\u2010inflammatory agents. Seven patients (63.6%) experienced treatment\u2010emergent adverse events, all of mild or moderate intensity, including skin and subcutaneous tissue disorders, general disorders and administration site conditions. No adverse event led to treatment discontinuation or death. A potential hypersensitivity event (face edema) resolved without intervention and was not considered treatment related. Spesolimab was well tolerated in a heterogeneous patient population with GPP, including those with comorbidities and concomitant medication use. The safety profile of spesolimab aligned with the EFFISAYIL 1 clinical trial results.\n                  <\/jats:p>","DOI":"10.1111\/1346-8138.70122","type":"journal-article","created":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T07:43:52Z","timestamp":1767167032000},"page":"351-356","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Real\u2010World Safety Profile of Spesolimab in Generalized Pustular Psoriasis: Insights From Japan as Part of a Multinational Expanded Access Program (\n                    <scp>EAP<\/scp>\n                    )"],"prefix":"10.1111","volume":"53","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8372-3754","authenticated-orcid":false,"given":"Akimichi","family":"Morita","sequence":"first","affiliation":[{"name":"Department of Geriatric and Environmental Dermatology Nagoya City University Graduate School of Medical Sciences  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3743-135X","authenticated-orcid":false,"given":"Yayoi","family":"Tada","sequence":"additional","affiliation":[{"name":"Department of Dermatology Teikyo University School of Medicine  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuichiro","family":"Tsunemi","sequence":"additional","affiliation":[{"name":"Saitama Medical University Hospital  Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1086-1803","authenticated-orcid":false,"given":"Mayumi","family":"Komine","sequence":"additional","affiliation":[{"name":"Jichi Medical University Hospital  Tochigi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuro","family":"Kanekura","sequence":"additional","affiliation":[{"name":"Department of Dermatology Kagoshima University Graduate School of Medical and Dental Sciences  Kagoshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8568-4349","authenticated-orcid":false,"given":"Shinichi","family":"Imafuku","sequence":"additional","affiliation":[{"name":"Fukuoka University Hospital  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9742-2282","authenticated-orcid":false,"given":"Toshiya","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Tohoku University Hospital  Miyagi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuemei","family":"Ding","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim (China), Investment Co. Ltd  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nichiren","family":"Pillai","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International Gmbh  Ingelheim Am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morihisa","family":"Saitoh","sequence":"additional","affiliation":[{"name":"Nippon Boehringer Ingelheim Co. Ltd  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael Sani","family":"Simoes","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International Gmbh  Ingelheim Am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nora","family":"P\u00f6ntynen","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International Gmbh  Ingelheim Am Rhein Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiichi","family":"Yamanaka","sequence":"additional","affiliation":[{"name":"Department of Dermatology Mie University Graduate School of Medicine  Tsu Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,30]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-021-00658-9"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.18851"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-021-00654-z"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1177\/24755303251318976"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40257-021-00663-y"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-024-01103-5"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-022-01801-4"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2023.2195165"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-023-01988-0"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2111563"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/2168479015578154"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2666-7568(22)00186-6"},{"key":"e_1_2_10_14_1","unstructured":"\u201cAn Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare\u2010Up in Generalized Pustular Psoriasis Who Have no Other Treatment Options \u201d(2024) https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT05200247."},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/24755303211021786"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.16609"}],"container-title":["The Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1346-8138.70122","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1346-8138.70122","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1346-8138.70122","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T10:31:38Z","timestamp":1777804298000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1346-8138.70122"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,12,30]]},"references-count":15,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1111\/1346-8138.70122"],"URL":"https:\/\/doi.org\/10.1111\/1346-8138.70122","archive":["Portico"],"relation":{},"ISSN":["0385-2407","1346-8138"],"issn-type":[{"value":"0385-2407","type":"print"},{"value":"1346-8138","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,30]]},"assertion":[{"value":"2025-10-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-26","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}