{"title":"Beyond Binary: The Potential of Ordinal Outcomes in Critical Care Trials.","authors":"Kelsey Hills-Dunlap,Marc Moss","doi":"10.1164/rccm.202502-0452ed","DOIUrl":"https://doi.org/10.1164/rccm.202502-0452ed","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"114 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143819291","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":"Assessing the Correlation Between Systemic Inflammation and GGO: Beyond a Single Indicator.","authors":"Rui Zhang,Xi Xi Chen,Jian Ping Zhou,Qing Yun Li","doi":"10.1164/rccm.202502-0327le","DOIUrl":"https://doi.org/10.1164/rccm.202502-0327le","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"23 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822686","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":"A New Target from a Target Trial Emulation: Allow Early Assisted Breathing.","authors":"Andrew J Admon,Christopher J Yarnell","doi":"10.1164/rccm.202501-0240ed","DOIUrl":"https://doi.org/10.1164/rccm.202501-0240ed","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"74 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143819009","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":"Lower Immunoglobulin G Levels Increased Exacerbation Risk in COPD: New Insights for Clinical Practice.","authors":"Yen-Fu Chen,Jung-Yien Chien,Hao-Chien Wang,Chong-Jen Yu","doi":"10.1164/rccm.202411-2177le","DOIUrl":"https://doi.org/10.1164/rccm.202411-2177le","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"108 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822621","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}
Cori L Daines,Deepika Polineni,Elizabeth Tullis,Stefano Costa,Rachel W Linnemann,Marcus A Mall,Edward F McKone,Bradley S Quon,Felix C Ringshausen,Hiran Selvadurai,Jennifer L Taylor-Cousar,Nicholas J Withers,Gregory S Sawicki,Timothy Lee,Neil Ahluwalia,Jessica Morlando Geiger,Mark Jennings,Yaoyuan Vincent Tan,David Waltz,Bonnie Ramsey,Matthias Griese,
{"title":"Long-Term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Adults and Adolescents with Cystic Fibrosis and at Least One F508del Allele: A Phase 3, Open-Label Extension Study.","authors":"Cori L Daines,Deepika Polineni,Elizabeth Tullis,Stefano Costa,Rachel W Linnemann,Marcus A Mall,Edward F McKone,Bradley S Quon,Felix C Ringshausen,Hiran Selvadurai,Jennifer L Taylor-Cousar,Nicholas J Withers,Gregory S Sawicki,Timothy Lee,Neil Ahluwalia,Jessica Morlando Geiger,Mark Jennings,Yaoyuan Vincent Tan,David Waltz,Bonnie Ramsey,Matthias Griese,","doi":"10.1164/rccm.202411-2231oc","DOIUrl":"https://doi.org/10.1164/rccm.202411-2231oc","url":null,"abstract":"RATIONALEClinical and real-world studies show elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is efficacious and safe in people with cystic fibrosis (CF) ≥12 years of age with at least one F508del allele.OBJECTIVESGiven the potential for life-long ELX/TEZ/IVA use, long-term safety and efficacy of ELX/TEZ/IVA was assessed.METHODSIn this phase 3, open-label, single-arm extension study, participants with F508del-minimal function genotypes (from 24-week parent study 445-102 [n = 399]) or with the F508del-F508del genotype (from 4-week parent study 445-103 [n = 107]) received ELX/TEZ/IVA (ELX 200 mg once daily, TEZ 100 mg once daily, and IVA 150 mg every 12 hours) over 192 weeks.MEASUREMENTS AND MAIN RESULTSPrimary endpoint was safety and tolerability. Mean exposure to ELX/TEZ/IVA was 172.6 weeks. Most participants had adverse events classified as mild (12.8%) or moderate (60.7%) in severity. Eighteen participants (3.6%) had adverse events that led to treatment discontinuation. After starting ELX/TEZ/IVA, participants had consistent increases in percent predicted FEV1 (ppFEV1), Cystic Fibrosis Questionnaire-Revised respiratory domain score, and body mass index, with decreases in sweat chloride concentration and pulmonary exacerbations rates; these improvements were maintained through 192 weeks. The mean annualized rate of change in ppFEV1 was 0.02 percentage points (95% CI, -0.14 to 0.19) after initiation of ELX/TEZ/IVA.CONCLUSIONSDuring this 192-week open label extension study, the longest clinical study of a CFTR modulator to date, ELX/TEZ/IVA remained generally safe and well-tolerated. Participants had sustained improvements in lung function, respiratory symptoms, CFTR function, pulmonary exacerbation rates, and nutritional status. The estimated annualized rate of change in ppFEV1 suggests no evidence of pulmonary function loss across the study population over the 4-year treatment period. These results confirm the favorable long-term safety profile and durable disease-modifying clinical benefits of ELX/TEZ/IVA in adolescents and adults with CF. Clinical trial registration available at www.CLINICALTRIALSgov, ID: NCT03525574.","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"5 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822690","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":"A Twist in the Fibrotic Tale: The Overlooked Vasculopathy in Idiopathic Pulmonary Fibrosis.","authors":"Adriano R Tonelli,Sandeep Sahay","doi":"10.1164/rccm.202502-0465ed","DOIUrl":"https://doi.org/10.1164/rccm.202502-0465ed","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"3 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143819008","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":"Reply to Rui et al.: Assessing the Correlation Between Systemic Inflammation and GGO: Beyond a Single Indicator.","authors":"Spyridon Fortis,Alejandro P Comellas","doi":"10.1164/rccm.202502-0372le","DOIUrl":"https://doi.org/10.1164/rccm.202502-0372le","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"2 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822689","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":"Reply to Chen et al. and to Fujimoto et al.","authors":"Michael Burnim,Nadia N Hansel,Nirupama Putcha","doi":"10.1164/rccm.202501-0043le","DOIUrl":"https://doi.org/10.1164/rccm.202501-0043le","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"25 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822685","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}
Yubo Feng,Chao Yan,Yuankai Huo,Bingshan Li,Zhongliang Zu,Michael C Smith,Mayur B Patel,You Chen
{"title":"Association of Delirium with Increased Risk of Mild Cognitive Impairment and Alzheimer's Disease and Related Dementias.","authors":"Yubo Feng,Chao Yan,Yuankai Huo,Bingshan Li,Zhongliang Zu,Michael C Smith,Mayur B Patel,You Chen","doi":"10.1164/rccm.202412-2449rl","DOIUrl":"https://doi.org/10.1164/rccm.202412-2449rl","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"183 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143819011","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}
Hajime Fujimoto,Taro Yasuma,Corina N D'Alessandro-Gabazza,Esteban C Gabazza,Osamu Hataji,Tetsu Kobayashi
{"title":"The Impact of Comorbidities on Serum IgG Levels and Exacerbation Risk in Chronic Obstructive Pulmonary Disease.","authors":"Hajime Fujimoto,Taro Yasuma,Corina N D'Alessandro-Gabazza,Esteban C Gabazza,Osamu Hataji,Tetsu Kobayashi","doi":"10.1164/rccm.202411-2341le","DOIUrl":"https://doi.org/10.1164/rccm.202411-2341le","url":null,"abstract":"","PeriodicalId":7664,"journal":{"name":"American journal of respiratory and critical care medicine","volume":"183 1","pages":""},"PeriodicalIF":24.7,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143822684","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}