{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T18:49:29Z","timestamp":1764874169322,"version":"3.37.3"},"reference-count":10,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2024,7,22]],"date-time":"2024-07-22T00:00:00Z","timestamp":1721606400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2024,7,22]],"date-time":"2024-07-22T00:00:00Z","timestamp":1721606400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Adv Ther"],"published-print":{"date-parts":[[2024,9]]},"DOI":"10.1007\/s12325-024-02940-8","type":"journal-article","created":{"date-parts":[[2024,7,22]],"date-time":"2024-07-22T18:02:12Z","timestamp":1721671332000},"page":"3557-3568","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics and Safety of Spesolimab in Healthy Chinese Subjects: An Open-Label, Phase I Study"],"prefix":"10.1007","volume":"41","clinical-trial-number":[{"clinical-trial-number":"nct04390568","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Guoying","family":"Cao","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Haijing","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jingjing","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Ishida","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Thoma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"Haeufel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sebastian","family":"Bossert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2966-9149","authenticated-orcid":false,"given":"Jing","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,7,22]]},"reference":[{"key":"2940_CR1","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1007\/s40257-021-00654-z","volume":"23","author":"SE Choon","year":"2022","unstructured":"Choon SE, Navarini AA, Pinter A. Clinical course and characteristics of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:21\u20139.","journal-title":"Am J Clin Dermatol"},{"key":"2940_CR2","doi-asserted-by":"publisher","first-page":"239","DOI":"10.1080\/1744666X.2019.1708193","volume":"16","author":"S Kharawala","year":"2020","unstructured":"Kharawala S, Golembesky AK, Bohn RL, Esser D. The clinical, humanistic, and economic burden of generalized pustular psoriasis: a structured review. Expert Rev Clin Immunol. 2020;16:239\u201352.","journal-title":"Expert Rev Clin Immunol"},{"key":"2940_CR3","doi-asserted-by":"publisher","first-page":"1402","DOI":"10.1016\/j.jaci.2021.09.035","volume":"149","author":"P Baum","year":"2022","unstructured":"Baum P, et al. Pustular psoriasis: molecular pathways and effects of spesolimab in generalized pustular psoriasis. J Allergy Clin Immunol. 2022;149:1402\u201312.","journal-title":"J Allergy Clin Immunol"},{"key":"2940_CR4","doi-asserted-by":"publisher","first-page":"2964","DOI":"10.1038\/jid.2015.288","volume":"135","author":"DM Berki","year":"2015","unstructured":"Berki DM, et al. Activating CARD14 mutations are associated with generalized pustular psoriasis but rarely account for familial recurrence in psoriasis vulgaris. J Invest Dermatol. 2015;135:2964\u201370.","journal-title":"J Invest Dermatol"},{"key":"2940_CR5","doi-asserted-by":"publisher","first-page":"1451","DOI":"10.1016\/j.jid.2019.11.024","volume":"140","author":"S Frey","year":"2020","unstructured":"Frey S, et al. Rare loss-of-function mutation in SERPINA3 in generalized pustular psoriasis. J Invest Dermatol. 2020;140:1451\u20135.","journal-title":"J Invest Dermatol"},{"key":"2940_CR6","doi-asserted-by":"publisher","first-page":"981","DOI":"10.1056\/NEJMc1811317","volume":"380","author":"H Bachelez","year":"2019","unstructured":"Bachelez H, et al. Inhibition of the interleukin-36 pathway for the treatment of generalized pustular psoriasis. N Engl J Med. 2019;380:981\u20133.","journal-title":"N Engl J Med"},{"key":"2940_CR7","doi-asserted-by":"publisher","first-page":"2431","DOI":"10.1056\/NEJMoa2111563","volume":"385","author":"H Bachelez","year":"2021","unstructured":"Bachelez H, et al. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385:2431\u201340.","journal-title":"N Engl J Med"},{"key":"2940_CR8","doi-asserted-by":"publisher","first-page":"730","DOI":"10.1111\/jdv.18820","volume":"37","author":"AA Navarini","year":"2023","unstructured":"Navarini AA, et al. Spesolimab improves patient-reported outcomes in patients with generalized pustular psoriasis: results from the Effisayil 1 study. J Eur Acad Dermatol Venereol. 2023;37:730\u20136.","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"2940_CR9","doi-asserted-by":"publisher","first-page":"1771","DOI":"10.1007\/s40262-022-01176-5","volume":"61","author":"D Joseph","year":"2022","unstructured":"Joseph D, Thoma C, Haeufel T, Li X. Assessment of the pharmacokinetics and safety of spesolimab, a humanised anti-interleukin-36 receptor monoclonal antibody, in healthy non-Japanese and Japanese subjects: results from Phase I clinical studies. Clin Pharmacokinet. 2022;61:1771\u201387.","journal-title":"Clin Pharmacokinet"},{"key":"2940_CR10","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1111\/cts.12582","volume":"12","author":"J Shen","year":"2019","unstructured":"Shen J, et al. Design and conduct considerations for first-in-human trials. Clin Transl Sci. 2019;12:6\u201319.","journal-title":"Clin Transl Sci"}],"container-title":["Advances in Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-024-02940-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12325-024-02940-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-024-02940-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,27]],"date-time":"2024-08-27T10:40:03Z","timestamp":1724755203000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12325-024-02940-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,22]]},"references-count":10,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,9]]}},"alternative-id":["2940"],"URL":"https:\/\/doi.org\/10.1007\/s12325-024-02940-8","relation":{},"ISSN":["0741-238X","1865-8652"],"issn-type":[{"type":"print","value":"0741-238X"},{"type":"electronic","value":"1865-8652"}],"subject":[],"published":{"date-parts":[[2024,7,22]]},"assertion":[{"value":"17 May 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 June 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 July 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Guoying Cao, Haijing Yang, Jingjing Wang, and Jing Zhang have no relevant financial or non-financial interests to disclose. Masahiro Ishida and Sebastian Bossert are employees of Boehringer Ingelheim. Christian Thoma is an employee of Boehringer Ingelheim International GmbH, Biberach, Germany. Thomas Haeufel is an employee of Boehringer Ingelheim International GmbH, Ingelheim, Germany.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The study protocol and any accompanying materials provided to the subjects were reviewed and approved by the Independent Ethics Committee of Huashan Hospital of the Shanghai Fudan University, Shanghai, China. This study was conducted in accordance with the principles of the Declaration of Helsinki, in accordance with the ICH GCP, and the applicable regulatory requirements. All subjects provided informed consent prior to entering the study. All subjects signed an informed consent form according to the local regulatory and legal requirements to participate in this study. This article does not contain identifiable information from any of the participating subjects.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}