{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:44:30Z","timestamp":1790729070625,"version":"4.1.0"},"reference-count":49,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,10,25]],"date-time":"2022-10-25T00:00:00Z","timestamp":1666656000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"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":[[2023,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Generalized pustular psoriasis is a potentially life\u2010threatening neutrophilic skin disease characterized by recurrent flares of widespread erythema and eruption of sterile pustules. In the Effisayil\u2122 1 study (NCT03782792), 53 patients with a generalized pustular psoriasis flare were treated with placebo or spesolimab, a humanized anti\u2010interleukin\u201036 receptor monoclonal antibody, the first targeted treatment to be studied in a randomized clinical trial. Spesolimab treatment resulted in rapid pustular and skin clearance, with an acceptable safety profile. Here, we evaluate the efficacy and safety of spesolimab in 29 Asian patients in the Effisayil\u2122 1 study. The primary endpoint, a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 (no visible pustules) at Week 1, was achieved by 10 patients (62.5%) randomized to spesolimab and one patient (7.7%) randomized to placebo (risk difference 54.8, 95% confidence interval [CI] 17.3\u201379.8). The key secondary endpoint, a GPPGA total score of 0 or 1 (clear or almost clear skin) at Week 1, was achieved by eight (50.0%) and two (15.4%) patients, respectively (risk difference 34.6, 95% CI \u22123.1\u201364.7). This was similar to previously published data in the overall population in whom the primary and key secondary endpoints were achieved by 54% versus 6% and 43% versus 11% of patients, respectively. The percentages of Asian patients randomized to spesolimab with a GPPGA pustulation subscore of 0 and GPPGA total score of 0 or 1 were sustained above 60% for up to 12\u2009weeks. In these patients, patient\u2010reported outcomes also improved and markers of systemic inflammation were normalized. Eleven (68.8%) and eight (61.5%) of spesolimab\u2010 and placebo\u2010treated patients, respectively, experienced at least one adverse event. In conclusion, spesolimab improved outcomes in Asian patients compared with placebo, supporting its use in the treatment of generalized pustular psoriasis flares.<\/jats:p>","DOI":"10.1111\/1346-8138.16609","type":"journal-article","created":{"date-parts":[[2022,10,25]],"date-time":"2022-10-25T13:29:10Z","timestamp":1666704550000},"page":"183-194","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Efficacy and safety of spesolimab in Asian patients with a generalized pustular psoriasis flare: Results from the randomized, double\u2010blind, placebo\u2010controlled Effisayil\u2122 1 study"],"prefix":"10.1111","volume":"50","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\/0000-0002-1498-1474","authenticated-orcid":false,"given":"Tsen\u2010Fang","family":"Tsai","sequence":"additional","affiliation":[{"name":"Department of Dermatology National Taiwan University Hospital and National Taiwan University College of Medicine  Taipei Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evelyn Yap Wen","family":"Yee","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital Pakar Sultanah Fatimah  Muar Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9526-1259","authenticated-orcid":false,"given":"Yukari","family":"Okubo","sequence":"additional","affiliation":[{"name":"Department of Dermatology Tokyo Medical University  Tokyo 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":"Department of Dermatology, Faculty of Medicine Fukuoka University  Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Zheng","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Second Affiliated Hospital School of Medicine, Zhejiang University  Hangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Li","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim (China) Investment Corporation Limited  Shanghai People's Republic of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manuel","family":"Quaresma","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH  Ingelheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Thoma","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim International GmbH  Biberach Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siew Eng","family":"Choon","sequence":"additional","affiliation":[{"name":"Department of Dermatology Hospital Sultanah Aminah, Johor Bahru, Malaysia, and Clinical School Johor Bahru, Monash University Malaysia  Johor Bahru Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,10,25]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1013068"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.14523"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.14386"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajhg.2011.07.022"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMc1811317"},{"key":"e_1_2_9_7_1","first-page":"669","article-title":"Generalized pustular psoriasis (Zumbusch): a French epidemiological survey","volume":"16","author":"Augey F","year":"2006","journal-title":"Eur J Dermatol"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555766871"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.20966"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.16217"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2021.1951192"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2021.1894108"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.16022"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamadermatol.2021.4640"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.16084"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2021.06.008"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2017.05.019"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1080\/1744666X.2021.1961580"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2016.08.056"},{"key":"e_1_2_9_20_1","first-page":"131","article-title":"Pustular psoriasis: pathophysiology and current treatment perspectives","volume":"6","author":"Benjegerdes KE","year":"2016","journal-title":"Psoriasis (Auckl)"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/exd.13699"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-021-00493-0"},{"key":"e_1_2_9_23_1","unstructured":"Thailand FDA. Lumicef\u00ae (brodalumab). Product information2019[cited 2022 May 31].https:\/\/www.fda.moph.go.th\/sites\/oss\/Drug%20Registration\/Lumicef%20Subcutaneous%20Injection%20210%20mg%20Syringe_1C%2015051\u201061%20(NBC)\/LUMICEF%20SUBCUTANEOUS%20_SPC(8\u201311\u201019).pdf."},{"key":"e_1_2_9_24_1","unstructured":"AbbVie.AbbVie announces first regulatory approval of SKYRIZI\u2122 (risankizumab) for the treatment of plaque psoriasis generalized pustular psoriasis and erythrodermic psoriasis and psoriatic arthritis in Japan. 2019 March 26 [cited 2022 May 31].https:\/\/news.abbvie.com\/news\/abbvie\u2010announces\u2010first\u2010regulatory\u2010approval\u2010skyrizi\u2010risankizumab\u2010for\u2010treatment\u2010plaque\u2010psoriasis\u2010generalized\u2010pustular\u2010psoriasis\u2010and\u2010erythrodermic\u2010psoriasis\u2010and\u2010psoriatic\u2010arthritis\u2010in\u2010japan.htm."},{"key":"e_1_2_9_25_1","unstructured":"UCB.CIMZIA\u00ae (certolizumab pegol) now available for patients in Japan living with multiple psoriatic diseases. 2020 January 28 [cited 2022 May 31].https:\/\/www.ucb.com\/stories\u2010media\/Press\u2010Releases\/article\/CIMZIA\u2010certolizumab\u2010pegol\u2010now\u2010Available\u2010for\u2010Patients\u2010in\u2010Japan\u2010living\u2010with\u2010Multiple\u2010Psoriatic\u2010Diseases."},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.13622"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.14294"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.14318"},{"key":"e_1_2_9_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.14702"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.13306"},{"key":"e_1_2_9_31_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13555-021-00666-x"},{"key":"e_1_2_9_32_1","doi-asserted-by":"publisher","DOI":"10.1111\/1346-8138.14664"},{"key":"e_1_2_9_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.15287"},{"key":"e_1_2_9_34_1","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000011741"},{"key":"e_1_2_9_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jid.2018.03.471"},{"key":"e_1_2_9_36_1","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2013.230"},{"key":"e_1_2_9_37_1","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2013.267"},{"key":"e_1_2_9_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jdermsci.2014.08.007"},{"key":"e_1_2_9_39_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00403-015-1611-x"},{"key":"e_1_2_9_40_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2111563"},{"key":"e_1_2_9_41_1","doi-asserted-by":"publisher","DOI":"10.1159\/000365390"},{"key":"e_1_2_9_42_1","first-page":"811","article-title":"Validation of the functional assessment of chronic illness therapy fatigue scale relative to other instrumentation in patients with rheumatoid arthritis","volume":"32","author":"Cella D","year":"2005","journal-title":"J Rheumatol"},{"key":"e_1_2_9_43_1","doi-asserted-by":"publisher","DOI":"10.1197\/S1069-6563(03)00372-5"},{"key":"e_1_2_9_44_1","doi-asserted-by":"publisher","DOI":"10.1080\/09546634.2019.1709612"},{"key":"e_1_2_9_45_1","doi-asserted-by":"publisher","DOI":"10.1111\/bjd.12501"},{"key":"e_1_2_9_46_1","doi-asserted-by":"publisher","DOI":"10.1097\/CM9.0000000000001163"},{"key":"e_1_2_9_47_1","doi-asserted-by":"publisher","DOI":"10.1038\/jid.2012.339"},{"key":"e_1_2_9_48_1","doi-asserted-by":"crossref","unstructured":"BurdenD OkuboY ZhengM Tha\u00e7iD van de KerkhofP HuN et al.Efficacy of spesolimab for the treatment of GPP flares across prespecified patient subgroups in the Effisayil\u2122 1 study. Skin Inflammation & Psoriasis International Network.2022Abstract number: SPIN\u2010220144.","DOI":"10.25251\/skin.7.supp.121"},{"key":"e_1_2_9_49_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaad.2011.01.032"},{"key":"e_1_2_9_50_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.12773"}],"container-title":["The Journal of Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1346-8138.16609","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1346-8138.16609","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1346-8138.16609","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,17]],"date-time":"2023-08-17T08:11:17Z","timestamp":1692259877000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1346-8138.16609"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,10,25]]},"references-count":49,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,2]]}},"alternative-id":["10.1111\/1346-8138.16609"],"URL":"https:\/\/doi.org\/10.1111\/1346-8138.16609","archive":["Portico"],"relation":{},"ISSN":["0385-2407","1346-8138"],"issn-type":[{"value":"0385-2407","type":"print"},{"value":"1346-8138","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,25]]},"assertion":[{"value":"2022-06-27","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-09-27","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-10-25","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}