{"id":"https://openalex.org/W4414039800","doi":"https://doi.org/10.1055/s-0045-1810774","title":"Efficacy and safety of seladelpar in patients with primary biliary cholangitis previously treated with fibrates or obeticholic acid","display_name":"Efficacy and safety of seladelpar in patients with primary biliary cholangitis previously treated with fibrates or obeticholic acid","publication_year":2025,"publication_date":"2025-09-01","ids":{"openalex":"https://openalex.org/W4414039800","doi":"https://doi.org/10.1055/s-0045-1810774"},"language":"en","primary_location":{"id":"doi:10.1055/s-0045-1810774","doi":"https://doi.org/10.1055/s-0045-1810774","is_oa":false,"landing_page_url":"https://doi.org/10.1055/s-0045-1810774","pdf_url":null,"source":{"id":"https://openalex.org/S189922908","display_name":"Zeitschrift f\u00fcr Gastroenterologie","issn_l":"0044-2771","issn":["0044-2771","1439-7803"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-3"],"host_organization":"https://openalex.org/P4310320000","host_organization_name":"Thieme Medical Publishers (Germany)","host_organization_lineage":["https://openalex.org/P4310320000"],"host_organization_lineage_names":["Thieme Medical Publishers (Germany)"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Zeitschrift f\u00fcr Gastroenterologie","raw_type":"proceedings-article"},"volume":null,"type":"conference-paper","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5107841296","display_name":"A. Villamil","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I2802359038","display_name":"Hospital Italiano de Buenos Aires","ror":"https://ror.org/00bq4rw46","country_code":"AR","type":"healthcare","lineage":["https://openalex.org/I2802359038"]}],"countries":["AR"],"is_corresponding":false,"raw_author_name":"A Villamil","raw_affiliation_strings":["The Liver Autoimmunity Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentinien"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"The Liver Autoimmunity Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentinien","institution_ids":["https://openalex.org/I2802359038"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5057057172","display_name":"Daniel Stephan Pratt","orcid":"https://orcid.org/0000-0002-7426-969X","observed_orcids":["https://orcid.org/0000-0002-7426-969X"]},"institutions":[{"id":"https://openalex.org/I4210087915","display_name":"Massachusetts General Hospital","ror":"https://ror.org/002pd6e78","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210087915","https://openalex.org/I48633490"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"D Pratt","raw_affiliation_strings":["Autoimmune and Cholestatic Liver Center, Massachusetts General Hospital, Boston, Vereinigte Staaten"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Autoimmune and Cholestatic Liver Center, Massachusetts General Hospital, Boston, Vereinigte Staaten","institution_ids":["https://openalex.org/I4210087915"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5081840796","display_name":"Andreas Emanuel Kremer","orcid":"https://orcid.org/0000-0002-9263-948X","observed_orcids":["https://orcid.org/0000-0002-9263-948X"]},"institutions":[{"id":"https://openalex.org/I202697423","display_name":"University of Zurich","ror":"https://ror.org/02crff812","country_code":"CH","type":"education","lineage":["https://openalex.org/I202697423"]},{"id":"https://openalex.org/I4210100468","display_name":"University Hospital Zurich","ror":"https://ror.org/01462r250","country_code":"CH","type":"healthcare","lineage":["https://openalex.org/I4210100468"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"A E Kremer","raw_affiliation_strings":["Department of Gastroenterology and Hepatology, University Hospital Z\u00fcrich, University of Z\u00fcrich, Z\u00fcrich, Schweiz"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Gastroenterology and Hepatology, University Hospital Z\u00fcrich, University of Z\u00fcrich, Z\u00fcrich, Schweiz","institution_ids":["https://openalex.org/I202697423","https://openalex.org/I4210100468"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5021281857","display_name":"Vincenza Calvaruso","orcid":"https://orcid.org/0000-0002-0287-1059","observed_orcids":["https://orcid.org/0000-0002-0287-1059"]},"institutions":[{"id":"https://openalex.org/I900890020","display_name":"University of Palermo","ror":"https://ror.org/044k9ta02","country_code":"IT","type":"education","lineage":["https://openalex.org/I900890020"]}],"countries":["IT"],"is_corresponding":false,"raw_author_name":"V Calvaruso","raw_affiliation_strings":["Gastroenterology and Hepatology Unit, University of Palermo, Palermo, Italien"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Gastroenterology and Hepatology Unit, University of Palermo, Palermo, Italien","institution_ids":["https://openalex.org/I900890020"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5049283017","display_name":"Elena G\u00f3mez Domi\u0144guez","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210101691","display_name":"Hospital Universitario 12 De Octubre","ror":"https://ror.org/00qyh5r35","country_code":"ES","type":"healthcare","lineage":["https://openalex.org/I4210101691","https://openalex.org/I4210139293"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"E G\u00f3mez Dominguez","raw_affiliation_strings":["Hepatology Unit, University Hospital 12 de Octubre, Madrid, Spanien"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Hepatology Unit, University Hospital 12 de Octubre, Madrid, Spanien","institution_ids":["https://openalex.org/I4210101691"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5090899739","display_name":"Xin Qi","orcid":"https://orcid.org/0000-0002-7193-5319","observed_orcids":["https://orcid.org/0000-0002-7193-5319","https://orcid.org/0009-0001-1390-1938"]},"institutions":[{"id":"https://openalex.org/I4210140816","display_name":"Gilead Sciences (United States)","ror":"https://ror.org/056546b03","country_code":"US","type":"company","lineage":["https://openalex.org/I4210140816"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"X Qi","raw_affiliation_strings":["Gilead Sciences, Inc., Foster City, Vereinigte Staaten"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Gilead Sciences, Inc., Foster City, Vereinigte Staaten","institution_ids":["https://openalex.org/I4210140816"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5010348335","display_name":"Sarah Proehl","orcid":"https://orcid.org/0009-0008-8255-3560","observed_orcids":["https://orcid.org/0009-0008-8255-3560"]},"institutions":[{"id":"https://openalex.org/I4210140816","display_name":"Gilead Sciences (United States)","ror":"https://ror.org/056546b03","country_code":"US","type":"company","lineage":["https://openalex.org/I4210140816"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"S Proehl","raw_affiliation_strings":["Gilead Sciences, Inc., Foster City, Vereinigte Staaten"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Gilead Sciences, Inc., Foster City, Vereinigte Staaten","institution_ids":["https://openalex.org/I4210140816"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004714398","display_name":"William Barchuk","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210140816","display_name":"Gilead Sciences (United States)","ror":"https://ror.org/056546b03","country_code":"US","type":"company","lineage":["https://openalex.org/I4210140816"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"W T Barchuk","raw_affiliation_strings":["Gilead Sciences, Inc., Foster City, Vereinigte Staaten"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Gilead Sciences, Inc., Foster City, Vereinigte Staaten","institution_ids":["https://openalex.org/I4210140816"]}]},{"author_position":"middle","author":{"id":null,"display_name":"T R Watkins","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210140816","display_name":"Gilead Sciences (United States)","ror":"https://ror.org/056546b03","country_code":"US","type":"company","lineage":["https://openalex.org/I4210140816"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"T R Watkins","raw_affiliation_strings":["Gilead Sciences, Inc., Foster City, Vereinigte Staaten"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Gilead Sciences, Inc., Foster City, Vereinigte Staaten","institution_ids":["https://openalex.org/I4210140816"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5046835105","display_name":"Stuart C. Gordon","orcid":"https://orcid.org/0000-0001-8666-3849","observed_orcids":["https://orcid.org/0000-0001-8666-3849"]},"institutions":[{"id":"https://openalex.org/I185443292","display_name":"Wayne State University","ror":"https://ror.org/01070mq45","country_code":"US","type":"education","lineage":["https://openalex.org/I185443292"]},{"id":"https://openalex.org/I2803043754","display_name":"Henry Ford Hospital","ror":"https://ror.org/0193sb042","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I154057602","https://openalex.org/I2803043754"]},{"id":"https://openalex.org/I87216513","display_name":"Michigan State University","ror":"https://ror.org/05hs6h993","country_code":"US","type":"education","lineage":["https://openalex.org/I87216513"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"S C Gordon","raw_affiliation_strings":["Division of Hepatology, Henry Ford Hospital, Wayne State University School of Medicine, Detroit, Vereinigte Staaten","Michigan State University College of Medicine, East Lansing, Vereinigte Staaten"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Hepatology, Henry Ford Hospital, Wayne State University School of Medicine, Detroit, Vereinigte Staaten","institution_ids":["https://openalex.org/I185443292","https://openalex.org/I2803043754"]},{"raw_affiliation_string":"Michigan State University College of Medicine, East Lansing, Vereinigte Staaten","institution_ids":["https://openalex.org/I87216513"]}]}],"institutions":[],"countries_distinct_count":5,"institutions_distinct_count":10,"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":0.42112125,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"63","issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11834","display_name":"Liver Diseases and Immunity","score":0.9980000257492065,"subfield":{"id":"https://openalex.org/subfields/2721","display_name":"Hepatology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11834","display_name":"Liver Diseases and Immunity","score":0.9980000257492065,"subfield":{"id":"https://openalex.org/subfields/2721","display_name":"Hepatology"},"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/T10570","display_name":"Drug Transport and Resistance Mechanisms","score":0.0003000000142492354,"subfield":{"id":"https://openalex.org/subfields/2730","display_name":"Oncology"},"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/T11072","display_name":"Peroxisome Proliferator-Activated Receptors","score":0.00019999999494757503,"subfield":{"id":"https://openalex.org/subfields/1312","display_name":"Molecular Biology"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/seladelpar","display_name":"seladelpar","score":0.9980000257492065},{"id":"https://openalex.org/keywords/primary-biliary-cholangitis","display_name":"primary biliary cirrhosis","score":0.972000002861023},{"id":"https://openalex.org/keywords/ppardelta-agonist","display_name":"PPAR\u03b4 agonist","score":0.9139999747276306},{"id":"https://openalex.org/keywords/obeticholic-acid","display_name":"obeticholic acid","score":0.8429999947547913},{"id":"https://openalex.org/keywords/fibrates","display_name":"fibrates","score":0.9039999842643738},{"id":"https://openalex.org/keywords/ursodeoxycholic-acid","display_name":"ursodeoxycholic acid","score":0.9459999799728394},{"id":"https://openalex.org/keywords/long-term-safety","display_name":"long-term safety","score":0.6869999766349792},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.5019999742507935},{"id":"https://openalex.org/keywords/assure-trial","display_name":"ASSURE trial","score":0.4690000116825104},{"id":"https://openalex.org/keywords/washout-period","display_name":"washout period","score":0.5090000033378601}],"concepts":[{"id":"https://openalex.org/C2777067796","wikidata":"https://www.wikidata.org/wiki/Q15708271","display_name":"Obeticholic acid","level":4,"score":0.984389066696167},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5951005816459656},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.5338220596313477},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.4919898211956024},{"id":"https://openalex.org/C170493617","wikidata":"https://www.wikidata.org/wiki/Q208467","display_name":"Receptor","level":2,"score":0.0},{"id":"https://openalex.org/C2778938600","wikidata":"https://www.wikidata.org/wiki/Q389934","display_name":"Agonist","level":3,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1055/s-0045-1810774","doi":"https://doi.org/10.1055/s-0045-1810774","is_oa":false,"landing_page_url":"https://doi.org/10.1055/s-0045-1810774","pdf_url":null,"source":{"id":"https://openalex.org/S189922908","display_name":"Zeitschrift f\u00fcr Gastroenterologie","issn_l":"0044-2771","issn":["0044-2771","1439-7803"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-3"],"host_organization":"https://openalex.org/P4310320000","host_organization_name":"Thieme Medical Publishers (Germany)","host_organization_lineage":["https://openalex.org/P4310320000"],"host_organization_lineage_names":["Thieme Medical Publishers (Germany)"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Zeitschrift f\u00fcr Gastroenterologie","raw_type":"proceedings-article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":1.0,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4414963810","https://openalex.org/W7114808473","https://openalex.org/W7204469980","https://openalex.org/W7221131290","https://openalex.org/W4414039785","https://openalex.org/W7165665670","https://openalex.org/W4414963684","https://openalex.org/W7221086632","https://openalex.org/W4411582238","https://openalex.org/W7221175722"],"abstract_inverted_index":{"Introduction:":[0],"Seladelpar":[1],"(SEL)":[2],"is":[3],"a":[4,44,141,188,270,299,355],"first-in-class":[5],"delpar":[6],"(selective":[7],"PPAR-delta":[8],"agonist)":[9],"indicated":[10],"for":[11,154],"the":[12,137,183],"treatment":[13],"of":[14,51,89,98,163,185,197,234,250,304,313,324,339,352],"primary":[15],"biliary":[16],"cholangitis":[17],"in":[18,24,36,53,91,121,129,149,156,179,376],"combination":[19],"with":[20,27,55,93,158,265,286,360,363],"ursodeoxycholic":[21],"acid":[22,102],"(UDCA)":[23],"patients":[25],"(pts)":[26],"an":[28,71],"inadequate":[29,56],"response":[30,191,359],"to":[31,39,58,65,147,309],"UDCA":[32],"or":[33,94,100,119,159,175],"as":[34],"monotherapy":[35],"pts":[37,54,92,123,155,186,216,230,245,264,275,285,293,344,347,364],"unable":[38],"tolerate":[40],"UDCA.":[41,59],"RESPONSE":[42,62,108,222],"was":[43,144,315],"Phase":[45,75],"3,":[46],"randomised,":[47],"placebo-controlled":[48],"clinical":[49],"trial":[50],"SEL":[52,116,128,171,173,226,241,260,319,341,361,370],"response/intolerance":[57],"Pts":[60,112],"completing":[61],"were":[63,134,152,332],"eligible":[64],"roll":[66],"over":[67,106],"into":[68,109,219],"ASSURE":[69,157,220,307],"(NCT03301506),":[70],"ongoing,":[72],"open-label,":[73],"long-term,":[74],"3":[76],"safety":[77],"trial.":[78],"Objectives:":[79],"Here,":[80],"we":[81],"describe":[82],"data":[83],"from":[84,107,221,345],"month":[85,256,302,310],"18":[86],"(month":[87],"6":[88,303],"ASSURE)":[90],"without":[95,160,276,294],"prior":[96,146,161,232,248,266,277,287,295,325,350,368],"use":[97,162,233,249,268,289,297,351],"fibrates":[99],"obeticholic":[101],"(OCA)":[103],"who":[104,217,348,365],"rolled":[105],"ASSURE.":[110,130,305],"Methodology:":[111],"received":[113,124,170],"10":[114,126],"mg":[115,127],"orally":[117],"daily":[118],"placebo":[120,176],"RESPONSE;":[122],"open-label":[125],"Fibrates":[131],"and":[132,140,165,202,211,227,242,320,342,373],"OCA":[133],"prohibited":[135],"during":[136],"study":[138],"period":[139],"6-week":[142],"washout":[143],"required":[145],"entry":[148],"RESPONSE.":[150,180],"Data":[151],"described":[153],"fibrates/OCA":[164,235,251,353],"based":[166],"on":[167],"whether":[168],"they":[169],"(continuous":[172],"pts)":[174,178],"(crossover":[177],"Efficacy":[181],"included":[182,207],"percentage":[184],"achieving":[187],"composite":[189],"biochemical":[190,358],"(CBR;":[192],"alkaline":[193],"phosphatase":[194],"[ALP]<1.67\u00d7upper":[195],"limit":[196],"normal":[198],"[ULN],":[199],"ALP":[200],"decrease\u226515%,":[201],"total":[203],"bilirubin\u2264ULN).":[204],"Safety":[205],"assessments":[206],"adverse":[208],"events":[209],"(AEs)":[210],"laboratory":[212],"parameters.":[213],"Results:":[214],"Among":[215,280],"continued":[218],"(n=158),":[223],"16":[224],"continuous":[225,240,259,318,340],"11":[228],"crossover":[229,244,281,321,343],"reported":[231,246,349,366],"(total,":[236,252],"n=27;":[237],"17%);":[238],"88":[239],"43":[243],"no":[247,328,367],"n=131;":[253],"83%).":[254],"At":[255],"18,":[257],"among":[258],"pts,":[261,282,322],"9/15":[262],"(60%)":[263],"fibrate/OCA":[267,278,288,296],"achieved":[269,298,354],"CBR":[271,300],"vs":[272,290],"54/87":[273],"(62%)":[274],"use.":[279,369],"7/11":[283],"(64%)":[284],"32/41":[291],"(78%)":[292],"at":[301],"From":[306],"initiation":[308],"6,":[311],"incidence":[312],"AEs":[314,331],"similar":[316,356],"across":[317],"regardless":[323],"OCA/fibrate":[326],"use;":[327],"treatment-related":[329],"serious":[330],"reported.":[333],"Conclusion:":[334],"In":[335],"this":[336,377],"interim":[337],"analysis":[338],"ASSURE,":[346],"sustained":[357],"compared":[362],"appeared":[371],"safe":[372],"well":[374],"tolerated":[375],"subgroup.":[378],"Publication":[379],"History":[380],"Article":[381],"published":[382],"online:":[383],"04":[384],"September":[385],"2025":[386],"\u00a9":[387],"2025.":[388],"Thieme.":[389],"All":[390],"rights":[391],"reserved.":[392],"Georg":[393],"Thieme":[394],"Verlag":[395],"KG":[396],"Oswald-Hesse-Stra\u00dfe":[397],"50,":[398],"70469":[399],"Stuttgart,":[400],"Germany":[401]},"counts_by_year":[],"updated_date":"2026-10-12T09:40:04.860316","created_date":"2025-10-10T00:00:00"}