{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T06:10:44Z","timestamp":1793686244956,"version":"4.5.1"},"reference-count":40,"publisher":"Elsevier BV","issue":"3","license":[{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2024,3,1]],"date-time":"2024-03-01T00:00:00Z","timestamp":1709251200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2023,11,6]],"date-time":"2023-11-06T00:00:00Z","timestamp":1699228800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ard.eular.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Annals of the Rheumatic Diseases"],"published-print":{"date-parts":[[2024,3]]},"DOI":"10.1136\/ard-2023-224691","type":"journal-article","created":{"date-parts":[[2023,11,6]],"date-time":"2023-11-06T13:20:17Z","timestamp":1699276817000},"page":"360-371","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":66,"title":["Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sj\u00f6gren\u2019s syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial"],"prefix":"10.1016","volume":"83","clinical-trial-number":[{"clinical-trial-number":"nct04035668","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04035668","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6478-7725","authenticated-orcid":false,"given":"Thomas","family":"D\u00f6rner","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Kaul","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ant\u00f3nia","family":"Sz\u00e1nt\u00f3","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jui-Cheng","family":"Tseng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Athena S","family":"Papas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilona","family":"Pylvaenaeinen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malika","family":"Hanser","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nasri","family":"Abdallah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Grioni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aida","family":"Santos Da Costa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8362-100X","authenticated-orcid":false,"given":"Enrico","family":"Ferrero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Gergely","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rainer","family":"Hillenbrand","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandre","family":"Avrameas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruno","family":"Cenni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard M","family":"Siegel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1136\/ard-2023-224691_bib1","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1016\/S0140-6736(05)66990-5","article-title":"Sj\u00f6gren's syndrome","volume":"366","author":"Fox","year":"2005","journal-title":"Lancet"},{"key":"10.1136\/ard-2023-224691_bib2","doi-asserted-by":"crossref","DOI":"10.1038\/nrdp.2016.47","article-title":"Sj\u00f6gren syndrome","volume":"2","author":"Brito-Zer\u00f3n","year":"2016","journal-title":"Nat Rev Dis Primers"},{"key":"10.1136\/ard-2023-224691_bib3","doi-asserted-by":"crossref","first-page":"931","DOI":"10.1056\/NEJMcp1702514","article-title":"Primary Sj\u00f6gren's syndrome","volume":"379","author":"Mariette","year":"2018","journal-title":"N Engl J Med"},{"key":"10.1136\/ard-2023-224691_bib4","first-page":"247","article-title":"The epidemiology of Sj\u00f6gren's syndrome","volume":"6","author":"Patel","year":"2014","journal-title":"Clin Epidemiol"},{"key":"10.1136\/ard-2023-224691_bib5","doi-asserted-by":"crossref","first-page":"1983","DOI":"10.1136\/annrheumdis-2014-205375","article-title":"Epidemiology of primary Sj\u00f6gren's syndrome: a systematic review and meta-analysis","volume":"74","author":"Qin","year":"2015","journal-title":"Ann Rheum Dis"},{"key":"10.1136\/ard-2023-224691_bib6","doi-asserted-by":"crossref","first-page":"93","DOI":"10.4081\/reumatismo.2017.1032","article-title":"The clinical spectrum of primary Sj\u00f6gren's syndrome: beyond Exocrine glands","volume":"69","author":"Leone","year":"2017","journal-title":"Reumatismo"},{"key":"10.1136\/ard-2023-224691_bib7","doi-asserted-by":"crossref","first-page":"2071","DOI":"10.1007\/s10067-022-06119-w","article-title":"A comprehensive overview of living with Sj\u00f6gren's: results of a national Sj\u00f6gren's foundation survey","volume":"41","author":"McCoy","year":"2022","journal-title":"Clin Rheumatol"},{"key":"10.1136\/ard-2023-224691_bib8","doi-asserted-by":"crossref","first-page":"309","DOI":"10.1006\/smim.1998.0123","article-title":"Btk function in B cell development and response","volume":"10","author":"Satterthwaite","year":"1998","journal-title":"Semin Immunol"},{"key":"10.1136\/ard-2023-224691_bib9","first-page":"945","article-title":"Bruton's tyrosine kinase is involved in innate and adaptive immunity","volume":"20","author":"Brunner","year":"2005","journal-title":"Histol Histopathol"},{"key":"10.1136\/ard-2023-224691_bib10","doi-asserted-by":"crossref","DOI":"10.3389\/fcell.2021.668131","article-title":"Targeting Bruton's tyrosine kinase in inflammatory and autoimmune Pathologies","volume":"9","author":"Neys","year":"2021","journal-title":"Front Cell Dev Biol"},{"key":"10.1136\/ard-2023-224691_bib11","doi-asserted-by":"crossref","DOI":"10.3389\/fcell.2021.630942","article-title":"Comparative analysis of BTK inhibitors and mechanisms underlying adverse effects","volume":"9","author":"Estupi\u00f1\u00e1n","year":"2021","journal-title":"Front Cell Dev Biol"},{"key":"10.1136\/ard-2023-224691_bib12","doi-asserted-by":"crossref","first-page":"5102","DOI":"10.1021\/acs.jmedchem.9b01916","article-title":"Discovery of Lou064 (Remibrutinib), a potent and highly selective Covalent inhibitor of Bruton's tyrosine kinase","volume":"63","author":"Angst","year":"2020","journal-title":"J Med Chem"},{"key":"10.1136\/ard-2023-224691_bib13","doi-asserted-by":"crossref","first-page":"5100","DOI":"10.1021\/acs.jmedchem.0c00597","article-title":"A fast and clean BTK inhibitor","volume":"63","author":"Gabizon","year":"2020","journal-title":"J Med Chem"},{"key":"10.1136\/ard-2023-224691_bib14","doi-asserted-by":"crossref","DOI":"10.1016\/j.bmcl.2022.128549","article-title":"Optimization of a novel Piperazinone series as potent selective peripheral Covalent BTK inhibitors","volume":"60","author":"Ma","year":"2022","journal-title":"Bioorg Med Chem Lett"},{"key":"10.1136\/ard-2023-224691_bib15","article-title":"Remibrutinib, a novel Bruton's tyrosine kinase inhibitor exhibits improved target selectivity and potency in vitro","author":"Pulz","year":"2022","journal-title":"ECTRIMS"},{"key":"10.1136\/ard-2023-224691_bib16","doi-asserted-by":"crossref","first-page":"1756","DOI":"10.1111\/cts.13005","article-title":"Remibrutinib (Lou064): A selective potent oral BTK inhibitor with promising clinical safety and pharmacodynamics in a randomized phase I trial","volume":"14","author":"Kaul","year":"2021","journal-title":"Clin Transl Sci"},{"key":"10.1136\/ard-2023-224691_bib17","doi-asserted-by":"crossref","first-page":"1498","DOI":"10.1016\/j.jaci.2022.08.027","article-title":"Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria","volume":"150","author":"Maurer","year":"2022","journal-title":"J Allergy Clin Immunol"},{"key":"10.1136\/ard-2023-224691_bib18","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1002\/art.39859","article-title":"American college of rheumatology\/European League against rheumatism classification criteria for primary Sj\u00f6gren's syndrome: A consensus and data-driven methodology involving three international patient cohorts","volume":"69","author":"Shiboski","year":"2017","journal-title":"Arthritis Rheumatol"},{"key":"10.1136\/ard-2023-224691_bib19","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1177\/0022034512451450","article-title":"Clock genes show circadian rhythms in salivary glands","volume":"91","author":"Zheng","year":"2012","journal-title":"J Dent Res"},{"key":"10.1136\/ard-2023-224691_bib20","doi-asserted-by":"crossref","first-page":"979","DOI":"10.1136\/annrheumdis-2021-222054","article-title":"Development and preliminary validation of the Sj\u00f6gren's tool for assessing response (STAR): a Consensual composite score for assessing treatment effect in primary Sj\u00f6gren's syndrome","volume":"81","author":"Seror","year":"2022","journal-title":"Ann Rheum Dis"},{"key":"10.1136\/ard-2023-224691_bib21","series-title":"R: A language and environment for statistical computing","author":"R Core T. R Core Team (2022)","year":"2022"},{"key":"10.1136\/ard-2023-224691_bib22","doi-asserted-by":"crossref","first-page":"7153","DOI":"10.1073\/pnas.1507719112","article-title":"Large-scale serum protein biomarker discovery in Duchenne muscular dystrophy","volume":"112","author":"Hathout","year":"2015","journal-title":"Proc Natl Acad Sci U S A"},{"key":"10.1136\/ard-2023-224691_bib23","doi-asserted-by":"crossref","first-page":"e47","DOI":"10.1093\/nar\/gkv007","article-title":"Limma powers differential expression analyses for RNA-sequencing and Microarray studies","volume":"43","author":"Ritchie","year":"2015","journal-title":"Nucleic Acids Res"},{"key":"10.1136\/ard-2023-224691_bib24","doi-asserted-by":"crossref","first-page":"1313","DOI":"10.1002\/art.40059","article-title":"Enhanced Bruton's tyrosine kinase activity in peripheral blood B lymphocytes from patients with autoimmune disease","volume":"69","author":"Corneth","year":"2017","journal-title":"Arthritis Rheumatol"},{"key":"10.1136\/ard-2023-224691_bib25","first-page":"2258","article-title":"Primary dental care treatment in primary Sj\u00f6gren's syndrome: a possible role in improving salivary flow rate","volume":"40","author":"Martins","year":"2022","journal-title":"Clin Exp Rheumatol"},{"key":"10.1136\/ard-2023-224691_bib26","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/j.oooo.2019.04.011","article-title":"Risk factors for Caries development in primary Sjogren syndrome","volume":"128","author":"Berman","year":"2019","journal-title":"Oral Surg Oral Med Oral Pathol Oral Radiol"},{"key":"10.1136\/ard-2023-224691_bib27","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1016\/S0140-6736(21)02251-0","article-title":"Safety and efficacy of subcutaneous Ianalumab (Vay736) in patients with primary Sj\u00f6gren's syndrome: a randomised, double-blind, placebo-controlled, phase 2B dose-finding trial","volume":"399","author":"Bowman","year":"2022","journal-title":"Lancet"},{"key":"10.1136\/ard-2023-224691_bib28","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1136\/annrheumdis-2020-218467","article-title":"Interleukin 6 receptor inhibition in primary Sj\u00f6gren syndrome: a Multicentre double-blind randomised placebo-controlled trial","volume":"80","author":"Felten","year":"2021","journal-title":"Ann Rheum Dis"},{"key":"10.1136\/ard-2023-224691_bib29","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2022.41451","article-title":"Efficacy and safety of low-dose interleukin 2 for primary Sj\u00f6gren syndrome: A randomized clinical trial","volume":"5","author":"He","year":"2022","journal-title":"JAMA Netw Open"},{"key":"10.1136\/ard-2023-224691_bib30","doi-asserted-by":"crossref","first-page":"526","DOI":"10.1136\/annrheumdis-2013-203991","article-title":"Efficacy and safety of Belimumab in primary Sj\u00f6gren's syndrome: results of the BELISS open-label phase II study","volume":"74","author":"Mariette","year":"2015","journal-title":"Ann Rheum Dis"},{"key":"10.1136\/ard-2023-224691_bib31","first-page":"2249","article-title":"Efficacy and safety of Belimumab given for 12 months in primary Sj\u00f6gren's syndrome: the BELISS open-label phase II study","volume":"54","author":"De Vita","year":"2015","journal-title":"Rheumatology (Oxford)"},{"key":"10.1136\/ard-2023-224691_bib32","doi-asserted-by":"crossref","DOI":"10.3390\/molecules28052400","article-title":"Bruton's tyrosine kinase inhibitors (Btkis): review of Preclinical studies and evaluation of clinical trials","volume":"28","author":"Rozkiewicz","year":"2023","journal-title":"Molecules"},{"key":"10.1136\/ard-2023-224691_bib33","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2021.662223","article-title":"Inhibitors and autoimmune diseases: making sense of BTK inhibitor specificity profiles and recent clinical trial successes and failures","volume":"12","author":"Ringheim","year":"2021","journal-title":"Front Immunol"},{"key":"10.1136\/ard-2023-224691_bib34","doi-asserted-by":"crossref","first-page":"4797","DOI":"10.1093\/rheumatology\/keac167","article-title":"Safety and efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Sj\u00f6gren's syndrome: a randomized, phase 2, double-blind, placebo-controlled study","volume":"61","author":"Price","year":"2022","journal-title":"Rheumatology (Oxford)"},{"key":"10.1136\/ard-2023-224691_bib35","doi-asserted-by":"crossref","first-page":"39218","DOI":"10.18632\/oncotarget.16836","article-title":"The Bruton's tyrosine kinase inhibitor Ibrutinib exerts immunomodulatory effects through regulation of tumor-infiltrating Macrophages","volume":"8","author":"Ping","year":"2017","journal-title":"Oncotarget"},{"key":"10.1136\/ard-2023-224691_bib36","doi-asserted-by":"crossref","first-page":"101","DOI":"10.1007\/s40744-019-00182-7","article-title":"Spebrutinib (CC-292) affects markers of B cell activation, Chemotaxis, and Osteoclasts in patients with rheumatoid arthritis: results from a mechanistic study","volume":"7","author":"Schafer","year":"2020","journal-title":"Rheumatol Ther"},{"key":"10.1136\/ard-2023-224691_bib37","article-title":"Human IgA-expressing bone marrow plasma cells characteristically Upregulate programmed cell death Protein-1 upon B cell receptor stimulation","volume":"11","author":"Wiedemann","year":"2020","journal-title":"Front Immunol"},{"key":"10.1136\/ard-2023-224691_bib38","doi-asserted-by":"crossref","first-page":"4064","DOI":"10.4049\/jimmunol.1501027","article-title":"Fc receptor-like 5 expression distinguishes two distinct Subsets of human circulating tissue-like memory B cells","volume":"196","author":"Li","year":"2016","journal-title":"J Immunol"},{"key":"10.1136\/ard-2023-224691_bib39","doi-asserted-by":"crossref","first-page":"783","DOI":"10.1084\/jem.20050879","article-title":"Expression of the Immunoregulatory molecule Fcrh4 defines a distinctive tissue-based population of memory B cells","volume":"202","author":"Ehrhardt","year":"2005","journal-title":"J Exp Med"},{"key":"10.1136\/ard-2023-224691_bib40","doi-asserted-by":"crossref","DOI":"10.1016\/j.jaut.2020.102439","article-title":"Gene expression profiling of epithelium-associated Fcrl4+ B cells in primary Sj\u00f6gren's syndrome reveals a pathogenic signature","volume":"109","author":"Verstappen","year":"2020","journal-title":"J Autoimmun"}],"container-title":["Annals of the Rheumatic Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003496724003649?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0003496724003649?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/ard-2023-224691","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T03:19:25Z","timestamp":1739503165000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0003496724003649"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,3]]},"references-count":40,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2024,3]]}},"alternative-id":["S0003496724003649"],"URL":"https:\/\/doi.org\/10.1136\/ard-2023-224691","relation":{},"ISSN":["0003-4967"],"issn-type":[{"value":"0003-4967","type":"print"}],"subject":[],"published":{"date-parts":[[2024,3]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sj\u00f6gren\u2019s syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial","name":"articletitle","label":"Article Title"},{"value":"Annals of the Rheumatic Diseases","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1136\/ard-2023-224691","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2024 \u00a9 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by Elsevier Inc. Published by Elsevier B.V. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}]}}