{"title":"Pegcetacoplan in C3 Glomerulopathy and Immune-Complex MPGN. Reply.","authors":"Fadi Fakhouri, Carla M Nester","doi":"10.1056/NEJMc2600540","DOIUrl":"https://doi.org/10.1056/NEJMc2600540","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 11","pages":"1140"},"PeriodicalIF":78.5,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147437878","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}
Sukruth A Shashikumar, Anand Vaidya, Victor J Kovac, Andrew W Allbee, Oreofe O Odejide
{"title":"A Feverish Pace.","authors":"Sukruth A Shashikumar, Anand Vaidya, Victor J Kovac, Andrew W Allbee, Oreofe O Odejide","doi":"10.1056/NEJMimc2511942","DOIUrl":"https://doi.org/10.1056/NEJMimc2511942","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 11","pages":"e20"},"PeriodicalIF":78.5,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147437881","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":"Current and Emerging Approaches to Evaluating Influenza Vaccine Performance.","authors":"","doi":"10.1056/NEJMx260005","DOIUrl":"https://doi.org/10.1056/NEJMx260005","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 11","pages":"1144"},"PeriodicalIF":78.5,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147437930","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":"Pegcetacoplan in C3 Glomerulopathy and Immune-Complex MPGN.","authors":"Sevcan A Bakkaloğlu,Emre Leventoğlu","doi":"10.1056/nejmc2600540","DOIUrl":"https://doi.org/10.1056/nejmc2600540","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"198 1","pages":"1139-1140"},"PeriodicalIF":158.5,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147393930","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":"Gene Therapy to Treat Profound Hearing Loss.","authors":"Paul Van de Heyning,Vincent Van Rompaey","doi":"10.1056/nejme2514326","DOIUrl":"https://doi.org/10.1056/nejme2514326","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"31 1","pages":"1126-1130"},"PeriodicalIF":158.5,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147393931","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":"Massive Intravascular Hemolysis from <i>Clostridium perfringens</i> Bacteremia.","authors":"Ann Tran, Carol Lee","doi":"10.1056/NEJMicm2514135","DOIUrl":"https://doi.org/10.1056/NEJMicm2514135","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 11","pages":"e19"},"PeriodicalIF":78.5,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147437855","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":"European Study of Prostate Cancer Screening - 23-Year Follow-up.","authors":"","doi":"10.1056/NEJMx250018","DOIUrl":"https://doi.org/10.1056/NEJMx250018","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"394 11","pages":"1144"},"PeriodicalIF":78.5,"publicationDate":"2026-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147437884","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":"Effects of Pervasive Immigration Enforcement on Children's Health.","authors":"Nikhil A Patel,Amy Hunter,Royce B Murray","doi":"10.1056/nejmp2601176","DOIUrl":"https://doi.org/10.1056/nejmp2601176","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"1 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2026-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147393933","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}
Steven D Nathan,Peter Smith,Chunqin Deng,Maria De Salvo,Wim Wuyts,Juana Pavie-Gallegos,Jin Woo Song,Mordechai R Kramer,Christopher S King,John A Mackintosh,Daniel Chambers,Georgina Viviana Miranda,Natalie Breytenbach,Leigh Peterson,Heidi Bell,Kevin R Flaherty,Juergen Behr,Vincent Cottin,
BACKGROUNDPreclinical data indicate that inhaled treprostinil may be useful for the treatment of idiopathic pulmonary fibrosis (IPF) through an antifibrotic mechanism, a premise that is supported by clinical observation.METHODSIn this phase 3, double-blind trial, we randomly assigned patients with IPF to receive inhaled treprostinil or placebo (12 breaths four times daily) over a period of 52 weeks. The primary end point was the change from baseline in the absolute forced vital capacity (FVC) at week 52. Secondary end points, which were analyzed in a prespecified order to control for multiplicity, were clinical worsening and acute exacerbation of IPF (each assessed in a time-to-event analysis), death by week 52, and the change from baseline in the percentage of predicted FVC, quality of life, and the diffusing capacity of the lungs for carbon monoxide by week 52. Safety was also assessed.RESULTSA total of 593 patients underwent randomization and received at least one dose of treprostinil (298 patients) or placebo (295 patients). Of these, 463 patients (224 in the treprostinil group and 239 in the placebo group) completed the trial assessments through week 52. The mean age of the patients was 71.7 years, 80.1% were men, the mean FVC at baseline was 76.8%, and 75.4% of the patients were receiving background antifibrotic therapy. The median change in FVC at week 52 was -49.9 ml (95% confidence interval [CI], -79.2 to -19.5) in the treprostinil group and -136.4 ml (95% CI, -172.5 to -104.0) in the placebo group; the between-group difference in the change in FVC was 95.6 ml (95% CI, 52.2 to 139.0; P<0.001). Clinical worsening occurred in 81 patients (27.2%) in the treprostinil group and 115 patients (39.0%) in the placebo group (hazard ratio, 0.71; 95% CI, 0.53 to 0.95; P = 0.02). No substantial between-group difference in the time to IPF exacerbation was observed, and so no further inferences with regard to subsequent secondary end points were made. The most common adverse event was cough, reported in 48.3% of the patients in the treprostinil group and 24.1% of those in the placebo group. Discontinuation of treprostinil or placebo occurred in 33.6% and 24.7%, respectively, with approximately half these patients citing adverse events as the primary reason for discontinuation.CONCLUSIONSIn patients with IPF, inhaled treprostinil was associated with a smaller decline in FVC and fewer clinical-worsening events than placebo over a period of 52 weeks. (Funded by United Therapeutics; TETON-2 ClinicalTrials.gov number, NCT05255991.).
临床前数据表明，吸入treprostiil可能通过抗纤维化机制用于治疗特发性肺纤维化（IPF），这一前提得到了临床观察的支持。在这项3期双盲试验中，我们随机分配IPF患者接受吸入曲前列替尼或安慰剂（12次呼吸，每天4次），持续52周。主要终点是第52周绝对强制肺活量（FVC）相对于基线的变化。次要终点，按照预先指定的顺序进行分析以控制多重性，包括IPF的临床恶化和急性加重（每项都在事件时间分析中评估），第52周的死亡，以及第52周预测FVC百分比的基线变化，生活质量和肺部一氧化碳扩散能力。安全性也进行了评估。结果共593例患者接受随机分组，接受至少一剂曲前列地尼（298例）或安慰剂（295例）治疗。其中，463名患者（treprostiil组224名，安慰剂组239名）在第52周完成了试验评估。患者的平均年龄为71.7岁，80.1%为男性，基线时平均FVC为76.8%，75.4%的患者正在接受背景抗纤维化治疗。第52周时，曲前列素组FVC的中位变化为-49.9 ml(95%可信区间[CI]， -79.2至-19.5)，安慰剂组为-136.4 ml (95% CI, -172.5至-104.0)；FVC变化组间差异为95.6 ml （95% CI, 52.2 ~ 139.0； P<0.001）。曲前列地尼组有81例（27.2%）患者出现临床恶化，安慰剂组有115例（39.0%）患者出现临床恶化（风险比0.71;95% CI 0.53 ~ 0.95; P = 0.02）。在IPF恶化的时间上没有观察到组间的实质性差异，因此没有进一步的推断关于随后的次要终点。最常见的不良反应是咳嗽，曲前列替尼组和安慰剂组分别有48.3%和24.1%的患者出现咳嗽。分别有33.6%和24.7%的患者停止使用曲前列替尼或安慰剂，其中大约一半的患者将不良事件作为停药的主要原因。结论：在52周的IPF患者中，吸入曲前列替尼与安慰剂相比，FVC下降幅度较小，临床恶化事件较少。（由United Therapeutics资助；TETON-2 ClinicalTrials.gov号码，NCT05255991.）。
{"title":"Inhaled Treprostinil for Idiopathic Pulmonary Fibrosis.","authors":"Steven D Nathan,Peter Smith,Chunqin Deng,Maria De Salvo,Wim Wuyts,Juana Pavie-Gallegos,Jin Woo Song,Mordechai R Kramer,Christopher S King,John A Mackintosh,Daniel Chambers,Georgina Viviana Miranda,Natalie Breytenbach,Leigh Peterson,Heidi Bell,Kevin R Flaherty,Juergen Behr,Vincent Cottin, ","doi":"10.1056/nejmoa2512911","DOIUrl":"https://doi.org/10.1056/nejmoa2512911","url":null,"abstract":"BACKGROUNDPreclinical data indicate that inhaled treprostinil may be useful for the treatment of idiopathic pulmonary fibrosis (IPF) through an antifibrotic mechanism, a premise that is supported by clinical observation.METHODSIn this phase 3, double-blind trial, we randomly assigned patients with IPF to receive inhaled treprostinil or placebo (12 breaths four times daily) over a period of 52 weeks. The primary end point was the change from baseline in the absolute forced vital capacity (FVC) at week 52. Secondary end points, which were analyzed in a prespecified order to control for multiplicity, were clinical worsening and acute exacerbation of IPF (each assessed in a time-to-event analysis), death by week 52, and the change from baseline in the percentage of predicted FVC, quality of life, and the diffusing capacity of the lungs for carbon monoxide by week 52. Safety was also assessed.RESULTSA total of 593 patients underwent randomization and received at least one dose of treprostinil (298 patients) or placebo (295 patients). Of these, 463 patients (224 in the treprostinil group and 239 in the placebo group) completed the trial assessments through week 52. The mean age of the patients was 71.7 years, 80.1% were men, the mean FVC at baseline was 76.8%, and 75.4% of the patients were receiving background antifibrotic therapy. The median change in FVC at week 52 was -49.9 ml (95% confidence interval [CI], -79.2 to -19.5) in the treprostinil group and -136.4 ml (95% CI, -172.5 to -104.0) in the placebo group; the between-group difference in the change in FVC was 95.6 ml (95% CI, 52.2 to 139.0; P<0.001). Clinical worsening occurred in 81 patients (27.2%) in the treprostinil group and 115 patients (39.0%) in the placebo group (hazard ratio, 0.71; 95% CI, 0.53 to 0.95; P = 0.02). No substantial between-group difference in the time to IPF exacerbation was observed, and so no further inferences with regard to subsequent secondary end points were made. The most common adverse event was cough, reported in 48.3% of the patients in the treprostinil group and 24.1% of those in the placebo group. Discontinuation of treprostinil or placebo occurred in 33.6% and 24.7%, respectively, with approximately half these patients citing adverse events as the primary reason for discontinuation.CONCLUSIONSIn patients with IPF, inhaled treprostinil was associated with a smaller decline in FVC and fewer clinical-worsening events than placebo over a period of 52 weeks. (Funded by United Therapeutics; TETON-2 ClinicalTrials.gov number, NCT05255991.).","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"415 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2026-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147393938","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}
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