{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T11:11:52Z","timestamp":1793272312597,"version":"4.5.0"},"reference-count":39,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2024,6,1]],"date-time":"2024-06-01T00:00:00Z","timestamp":1717200000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T00:00:00Z","timestamp":1717545600000},"content-version":"vor","delay-in-days":4,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Nat Med"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Sj\u00f6gren\u2019s disease (SjD) is a chronic, systemic autoimmune disease with no approved disease-modifying therapies. Dazodalibep (DAZ), a novel nonantibody fusion protein, is a CD40 ligand antagonist that blocks costimulatory signals between T and B\u2009cells and antigen-presenting cells, and therefore may suppress the wide spectrum of cellular and humoral responses that drive autoimmunity in SjD. This study was a phase\u20092, randomized, double-blinded, placebo (PBO)-controlled trial of DAZ with a crossover stage in two distinct populations of participants with SjD. Population 1 had moderate-to-severe systemic disease activity and population 2 had an unacceptable symptom burden and limited systemic organ involvement. All participants had a diagnosis of SjD, with 21.6% and 10.1% having an associated connective tissue disease (rheumatoid arthritis or systemic lupus erythematosus) in populations 1 and 2, respectively. The remaining participants would be considered as having primary Sj\u00f6gren\u2019s syndrome. The primary endpoint for population 1 (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u200974) was the change from baseline in the European League Against Rheumatism Sj\u00f6gren\u2019s Syndrome Disease Activity Index at day\u2009169. The primary endpoint for population 2 (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u2009109) was the change from baseline in the European League Against Rheumatism Sj\u00f6gren\u2019s Syndrome Patient Reported Index at day\u2009169. The primary endpoints (least squares mean\u2009\u00b1\u2009standard error) were achieved with statistical significance for both population 1 (DAZ, \u22126.3\u2009\u00b1\u20090.6; PBO, \u22124.1\u2009\u00b1\u20090.6;\n                    <jats:italic>P<\/jats:italic>\n                    \u2009=\u20090.0167) and population 2 (DAZ, \u22121.8\u2009\u00b1\u20090.2; PBO, \u22120.5\u2009\u00b1\u20090.2;\n                    <jats:italic>P<\/jats:italic>\n                    \u2009=\u20090.0002). DAZ was generally safe and well tolerated. Among the most frequently reported adverse events were COVID-19, diarrhea, headache, nasopharyngitis, upper respiratory tract infection, arthralgia, constipation and urinary tract infection. In summary, DAZ appears to be a potential new therapy for SjD and its efficacy implies an important role for the CD40\/CD40 ligand pathway in its pathogenesis. ClinicalTrials.gov identifier:\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/classic.clinicaltrials.gov\/ct2\/show\/NCT04129164\">NCT04129164<\/jats:ext-link>\n                    .\n                  <\/jats:p>","DOI":"10.1038\/s41591-024-03009-3","type":"journal-article","created":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T06:03:42Z","timestamp":1717567422000},"page":"1583-1592","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":94,"title":["CD40 ligand antagonist dazodalibep in Sj\u00f6gren\u2019s disease: a randomized, double-blinded, placebo-controlled, phase 2 trial"],"prefix":"10.1038","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1181-0650","authenticated-orcid":false,"given":"E. 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Ophthalmol."}],"container-title":["Nature Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.nature.com\/articles\/s41591-024-03009-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41591-024-03009-3","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.nature.com\/articles\/s41591-024-03009-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,19]],"date-time":"2024-06-19T10:20:16Z","timestamp":1718792416000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.nature.com\/articles\/s41591-024-03009-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6]]},"references-count":39,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["3009"],"URL":"https:\/\/doi.org\/10.1038\/s41591-024-03009-3","relation":{},"ISSN":["1078-8956","1546-170X"],"issn-type":[{"value":"1078-8956","type":"print"},{"value":"1546-170X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6]]},"assertion":[{"value":"21 December 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 April 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 June 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"E.W.S. has consulted for Horizon Therapeutics, Bristol Myers Squibb, Related Sciences, ModernaTx Inc., CSL Behring, Resolve Therapeutics, Zenus Pharmaceuticals\/Everest Clinical Research Corporation, Scleroderma Research Foundation\/Medpace and Sonoma Biotherapeutics; and receives royalties from UpToDate. A.N.B. has consulted for Bristol Myers Squibb and iCell Gene Therapeutics. W.-F.N. has undertaken clinical trials and provided consultancy or expert advice in the area of Sj\u00f6gren\u2019s syndrome to the following companies: GlaxoSmithKline, MedImmune, UCB, Abbvie, Roche, Eli Lilly, Takeda, Resolves Therapeutics, Sanofi, Novartis and BMS. G.N. has undertaken clinical trials in the area of Sj\u00f6gren\u2019s syndrome to the following companies: MedImmune, Horizon, Roche, BMS, Janssen and Novartis; and has provided consultancy or expert advice to Novartis and Janssen. C.B. has undertaken clinical trials and provided consultancy or expert advice in the area of Sj\u00f6gren\u2019s syndrome to the following companies: GlaxoSmithKline, UCB, Sanofi, Novartis, Aurinia and Horizon. T.K.T. has grant support from Chiesi USA, Horizon Therapeutics, Amgen and X4 Pharmaceuticals; and has provided consultancy for X4 Pharmaceuticals and Chiesi. A.P. has provided consultancy or expert advice in the area of Sj\u00f6gren\u2019s syndrome to Novartis. V.D.-P. has undertaken clinical trials and provided consultancy or expert advice in the area of Sj\u00f6gren\u2019s syndrome to the following companies: UCB, Sanofi, Novartis, BMS and Horizon. L.W., W.X., T.-H.P., K.S., W.A.R. and I.A. are employees of Amgen Inc. (formerly Horizon Therapeutics) and own stock.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}