{"title":"Remibrutinib in Chronic Spontaneous Urticaria. Reply.","authors":"Martin Metz, Sibylle Haemmerle","doi":"10.1056/NEJMc2504726","DOIUrl":"https://doi.org/10.1056/NEJMc2504726","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"2077-2078"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Suellen Li, Alison E Burke, Natalie Koscal, Caren G Solomon
{"title":"A Burning Question.","authors":"Suellen Li, Alison E Burke, Natalie Koscal, Caren G Solomon","doi":"10.1056/NEJMp2414536","DOIUrl":"https://doi.org/10.1056/NEJMp2414536","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"e48"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Daniel Blockmans, Sara K Penn, Arathi R Setty, Wolfgang A Schmidt, Andrea Rubbert-Roth, Ellen M Hauge, Helen I Keen, Tomonori Ishii, Nader Khalidi, Christian Dejaco, Maria C Cid, Bernhard Hellmich, Meng Liu, Weihan Zhao, Ivan Lagunes, Ana B Romero, Peter K Wung, Peter A Merkel
{"title":"A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis.","authors":"Daniel Blockmans, Sara K Penn, Arathi R Setty, Wolfgang A Schmidt, Andrea Rubbert-Roth, Ellen M Hauge, Helen I Keen, Tomonori Ishii, Nader Khalidi, Christian Dejaco, Maria C Cid, Bernhard Hellmich, Meng Liu, Weihan Zhao, Ivan Lagunes, Ana B Romero, Peter K Wung, Peter A Merkel","doi":"10.1056/NEJMoa2413449","DOIUrl":"10.1056/NEJMoa2413449","url":null,"abstract":"<p><strong>Background: </strong>Giant-cell arteritis is a systemic vasculitis with limited treatment options. The efficacy and safety of upadacitinib - a selective Janus kinase (JAK) inhibitor that blocks the signaling of several cytokines, including interleukin-6 and interferon-γ - are unknown in patients with giant-cell arteritis.</p><p><strong>Methods: </strong>We randomly assigned patients with new-onset or relapsing giant-cell arteritis, in a 2:1:1 ratio, to receive upadacitinib at a dose of 15 mg or 7.5 mg orally once daily plus a 26-week glucocorticoid taper or placebo plus a 52-week glucocorticoid taper. The primary end point was sustained remission at week 52, defined by the absence of signs or symptoms of giant-cell arteritis from week 12 through week 52 and adherence to the protocol-specified glucocorticoid taper.</p><p><strong>Results: </strong>A total of 209 patients received upadacitinib at a dose of 15 mg, 107 received upadacitinib at a dose of 7.5 mg, and 112 received placebo; 70% of the patients had new-onset giant-cell arteritis. Upadacitinib at a dose of 15 mg showed superiority over placebo with respect to the primary end point (46.4% [95% confidence interval {CI}, 39.6 to 53.2] vs. 29.0% [95% CI, 20.6 to 37.5]; P = 0.002). Upadacitinib at a dose of 15 mg was superior to placebo in the analysis of the hierarchically prespecified and multiplicity-controlled key secondary end points of sustained complete remission, time to a disease flare, cumulative glucocorticoid exposure, and patient-reported outcomes. Upadacitinib at a dose of 7.5 mg was not superior to placebo with respect to the primary end point (41.1% [95% CI, 31.8 to 50.4]). Safety outcomes during the treatment period of 52 weeks were similar in the upadacitinib and placebo groups. Although cardiovascular risk is a potential concern with a JAK inhibitor, no major adverse cardiovascular events occurred in the upadacitinib groups.</p><p><strong>Conclusions: </strong>In patients with giant-cell arteritis, upadacitinib at a dose of 15 mg - but not 7.5 mg - with a 26-week glucocorticoid taper showed efficacy superior to that of placebo with a 52-week glucocorticoid taper. (Funded by AbbVie; SELECT-GCA ClinicalTrials.gov number, NCT03725202.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"2013-2024"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143774937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Meaning of Goodbye.","authors":"David Pisetsky","doi":"10.1056/NEJMp2416194","DOIUrl":"10.1056/NEJMp2416194","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1984-1985"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144152903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Seeking Multiorgan Benefits with Cardiovascular-Kidney-Metabolic Drug Therapy.","authors":"Faiez Zannad","doi":"10.1056/NEJMe2503600","DOIUrl":"https://doi.org/10.1056/NEJMe2503600","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"2061-2062"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Sotatercept and the Clinical Transformation of Pulmonary Arterial Hypertension.","authors":"Bradley A Maron","doi":"10.1056/NEJMe2503944","DOIUrl":"https://doi.org/10.1056/NEJMe2503944","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"2059-2061"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Martín Hunter, Ignacio Lopez Saubidet, Tomás Amerio, Maria V Leone
{"title":"Case 15-2025: A 52-Year-Old Man with Fever, Nausea, and Respiratory Failure.","authors":"Martín Hunter, Ignacio Lopez Saubidet, Tomás Amerio, Maria V Leone","doi":"10.1056/NEJMcpc2412526","DOIUrl":"https://doi.org/10.1056/NEJMcpc2412526","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"2049-2057"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Upadacitinib - An Up-and-Comer for Treatment of Giant-Cell Arteritis.","authors":"Matthew J Koster, Kenneth J Warrington","doi":"10.1056/NEJMe2503584","DOIUrl":"https://doi.org/10.1056/NEJMe2503584","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"2062-2064"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sanjit S Jolly, Marc-André d'Entremont, Shun Fu Lee
{"title":"Colchicine and Spironolactone in Acute Myocardial Infarction. Reply.","authors":"Sanjit S Jolly, Marc-André d'Entremont, Shun Fu Lee","doi":"10.1056/NEJMc2503896","DOIUrl":"https://doi.org/10.1056/NEJMc2503896","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"2074-2075"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Remibrutinib in Chronic Spontaneous Urticaria.","authors":"Álvaro Pousada-Fonseca, Jorge Pedreira-Bouzas","doi":"10.1056/NEJMc2504726","DOIUrl":"https://doi.org/10.1056/NEJMc2504726","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"392 20","pages":"2076"},"PeriodicalIF":96.2,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}