{"id":"https://openalex.org/W7225736497","doi":"https://doi.org/10.25251/7zfb6071","title":"Long-term (\u22653 year) efficacy and safety of subcutaneous spesolimab for treatment of generalized pustular psoriasis: results from the EFFISAYIL program","display_name":"Long-term (\u22653 year) efficacy and safety of subcutaneous spesolimab for treatment of generalized pustular psoriasis: results from the EFFISAYIL program","publication_year":2026,"publication_date":"2026-11-10","ids":{"openalex":"https://openalex.org/W7225736497","doi":"https://doi.org/10.25251/7zfb6071"},"language":"en","primary_location":{"id":"doi:10.25251/7zfb6071","doi":"https://doi.org/10.25251/7zfb6071","is_oa":true,"landing_page_url":"https://doi.org/10.25251/7zfb6071","pdf_url":null,"source":{"id":"https://openalex.org/S4210210594","display_name":"SKIN The Journal of Cutaneous Medicine","issn_l":"2574-1624","issn":["2574-1624"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","poland-20"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"SKIN The Journal of Cutaneous Medicine","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","doaj"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://doi.org/10.25251/7zfb6071","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5058475475","display_name":"Johann Eli Gudjonsson","orcid":"https://orcid.org/0000-0002-0080-0812","observed_orcids":["https://orcid.org/0000-0002-0080-0812"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Johann E. Gudjonsson","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5045731013","display_name":"Alexander  Andreas Navarini","orcid":"https://orcid.org/0000-0001-7059-632X","observed_orcids":["https://orcid.org/0000-0001-7059-632X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Alexander A. Navarini","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5124940473","display_name":"Richard G. Langley","orcid":"https://orcid.org/0000-0003-4730-2164","observed_orcids":["https://orcid.org/0000-0003-4730-2164"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Richard G. Langley","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5080337749","display_name":"James G. Krueger","orcid":"https://orcid.org/0000-0002-3775-1778","observed_orcids":["https://orcid.org/0000-0002-3775-1778"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"James G. Krueger","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083722360","display_name":"Arash Mostaghimi","orcid":"https://orcid.org/0000-0002-6084-5617","observed_orcids":["https://orcid.org/0000-0002-6084-5617"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Arash Mostaghimi","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161368636","display_name":"A. David Burden","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"A. David Burden","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161410635","display_name":"Ming Tang","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ming Tang","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5064818960","display_name":"Juliann Reardon","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Juliann Reardon","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5074403803","display_name":"Christian Thoma","orcid":"https://orcid.org/0000-0002-0967-2028","observed_orcids":["https://orcid.org/0000-0002-0967-2028"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Christian Thoma","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5161372842","display_name":"Akimichi Morita","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Akimichi Morita","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"10","issue":"6","first_page":"s850","last_page":"s850"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10469","display_name":"Psoriasis: Treatment and Pathogenesis","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T10469","display_name":"Psoriasis: Treatment and Pathogenesis","score":0.9994999766349792,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10837","display_name":"Dermatology and Skin Diseases","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/2708","display_name":"Dermatology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11092","display_name":"Spondyloarthritis Studies and Treatments","score":9.999999747378752e-05,"subfield":{"id":"https://openalex.org/subfields/2745","display_name":"Rheumatology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9290000200271606},{"id":"https://openalex.org/C2776907424","wikidata":"https://www.wikidata.org/wiki/Q5532501","display_name":"Generalized pustular psoriasis","level":3,"score":0.7311999797821045},{"id":"https://openalex.org/C2779588948","wikidata":"https://www.wikidata.org/wiki/Q628261","display_name":"Flare","level":2,"score":0.7139999866485596},{"id":"https://openalex.org/C2777288759","wikidata":"https://www.wikidata.org/wiki/Q4164182","display_name":"Dosing","level":2,"score":0.6421999931335449},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.38449999690055847},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.37880000472068787},{"id":"https://openalex.org/C16005928","wikidata":"https://www.wikidata.org/wiki/Q171171","display_name":"Dermatology","level":1,"score":0.37790000438690186},{"id":"https://openalex.org/C2987315675","wikidata":"https://www.wikidata.org/wiki/Q1773974","display_name":"Disease control","level":2,"score":0.3747999966144562},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.36800000071525574},{"id":"https://openalex.org/C2992053201","wikidata":"https://www.wikidata.org/wiki/Q2585693","display_name":"Clinical efficacy","level":2,"score":0.3637000024318695},{"id":"https://openalex.org/C2780564577","wikidata":"https://www.wikidata.org/wiki/Q179945","display_name":"Psoriasis","level":2,"score":0.34470000863075256},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3280999958515167},{"id":"https://openalex.org/C2993769353","wikidata":"https://www.wikidata.org/wiki/Q7598360","display_name":"Standard of care","level":2,"score":0.30809998512268066},{"id":"https://openalex.org/C2779134260","wikidata":"https://www.wikidata.org/wiki/Q12136","display_name":"Disease","level":2,"score":0.30709999799728394},{"id":"https://openalex.org/C151032500","wikidata":"https://www.wikidata.org/wiki/Q5194182","display_name":"Cumulative dose","level":2,"score":0.2825999855995178},{"id":"https://openalex.org/C187212893","wikidata":"https://www.wikidata.org/wiki/Q123028","display_name":"Pediatrics","level":1,"score":0.26019999384880066}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.25251/7zfb6071","doi":"https://doi.org/10.25251/7zfb6071","is_oa":true,"landing_page_url":"https://doi.org/10.25251/7zfb6071","pdf_url":null,"source":{"id":"https://openalex.org/S4210210594","display_name":"SKIN The Journal of Cutaneous Medicine","issn_l":"2574-1624","issn":["2574-1624"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","poland-20"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"SKIN The Journal of Cutaneous Medicine","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.25251/7zfb6071","doi":"https://doi.org/10.25251/7zfb6071","is_oa":true,"landing_page_url":"https://doi.org/10.25251/7zfb6071","pdf_url":null,"source":{"id":"https://openalex.org/S4210210594","display_name":"SKIN The Journal of Cutaneous Medicine","issn_l":"2574-1624","issn":["2574-1624"],"is_oa":true,"is_in_doaj":true,"is_core":true,"listed_in":["cwts-core","doaj","poland-20"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"SKIN The Journal of Cutaneous Medicine","raw_type":"journal-article"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":2,"referenced_works":["https://openalex.org/W4200421636","https://openalex.org/W4308256951"],"related_works":[],"abstract_inverted_index":{"Introduction:":[0],"Spesolimab":[1],"is":[2,112,278],"an":[3,113],"anti-interleukin-36":[4],"monoclonal":[5],"antibody":[6],"approved":[7],"for":[8,32,105,133,146,159,202],"the":[9,41,50,88,121,223,236,249,257,282,292],"treatment":[10,31,58,104,132,152,189,217,277],"of":[11,54,120,155,157,174,198,225,243,261,285,295],"generalized":[12],"pustular":[13],"psoriasis":[14],"(GPP).":[15],"We":[16],"report":[17],"long-term":[18,55,82,118,188,272,300],"efficacy":[19,51,83],"and":[20,52,65,79,84,128,205],"safety":[21,53,85,259,293],"data":[22,86,253],"from":[23,87,227,266],"patients":[24,60,94,167,288],"with":[25,61,70,95,256,289,299],"GPP":[26,96,147],"receiving":[27],"subcutaneous":[28],"(SC)":[29],"spesolimab":[30,38,57,101,151,216,276,296],"\u22653":[33,106,203],"years":[34,204],"since":[35],"their":[36],"first":[37],"dose":[39,173],"in":[40,59,91,222,280,287],"EFFISAYIL":[42,89,109,122,129,237],"program.":[43],"The":[44],"objectives":[45],"were":[46,139,254],"to":[47,219,234,239],"(1)":[48],"describe":[49],"SC":[56,100,175,179,215,275],"GPP,":[62,160],"a":[63,71,143,199,220,240],"chronic":[64],"potentially":[66],"life-threatening":[67],"inflammatory":[68],"disease":[69,77],"heterogenous":[72],"clinical":[73],"course":[74],"requiring":[75],"continuous":[76,103],"control":[78],"(2)":[80],"communicate":[81],"program":[90,238],"over":[92,248],"100":[93],"who":[97],"have":[98,168,186],"received":[99,169,187],"as":[102],"years.":[107],"Methods:":[108],"ON":[110],"(NCT03886246)":[111],"ongoing":[114],"open-label,":[115],"multicenter,":[116],"5-year,":[117],"extension":[119],"1":[123],"(intravenous":[124],"[IV]":[125],"flare":[126,134,148,200,212],"treatment)":[127],"2":[130],"(SC":[131],"prevention)":[135],"trials.":[136],"Flare":[137],"events":[138],"defined":[140],"as:":[141],"meeting":[142],"protocol-defined":[144],"threshold":[145],"and/or":[149,153],"IV":[150],"use":[154],"standard":[156],"care":[158],"per":[161,230,245],"investigator":[162],"discretion.":[163],"Results:":[164],"Overall,":[165],"159":[166],"at":[170,209],"least":[171,210],"one":[172,211],"spesolimab,":[176],"considering":[177],"all":[178],"dosing":[180],"regimens":[181],"tested;":[182],"most":[183],"(n=118,":[184],"74.2%)":[185],"(\u22653":[190,273],"years).":[191],"Of":[192],"these,":[193],"74.6%":[194],"(n=88)":[195],"remained":[196],"free":[197],"event":[201],"25.4%":[206],"(n=30)":[207],"had":[208],"event.":[213],"Long-term":[214],"led":[218],"reduction":[221],"number":[224,284],"flares":[226,229,286],"2.0":[228],"year":[231,246],"reported":[232],"prior":[233],"entering":[235],"cumulative":[241,283],"mean":[242],"0.13":[244],"(0.4":[247],"3-year":[250],"period).":[251],"Safety":[252],"consistent":[255],"known":[258],"profile":[260,294],"spesolimab.":[262],"Conclusion:":[263],"Preliminary":[264],"results":[265],"this":[267],"open-label":[268],"study":[269],"demonstrate":[270],"that":[271],"years)":[274],"effective":[279],"reducing":[281],"GPP.":[290],"Additionally,":[291],"remains":[297],"unchanged":[298],"use.":[301]},"counts_by_year":[],"updated_date":"2026-11-11T12:16:26.678958","created_date":"2026-11-11T00:00:00"}