Background: Effective targets for systolic blood-pressure control in patients with type 2 diabetes are unclear.
Methods: We enrolled patients 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. Patients were randomly assigned to receive intensive treatment that targeted a systolic blood pressure of less than 120 mm Hg or standard treatment that targeted a systolic blood pressure of less than 140 mm Hg for up to 5 years. The primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes. Multiple imputation was used for missing outcome data, with an assumption that the data were missing at random.
Results: Of 12,821 patients (6414 patients in the intensive-treatment group and 6407 in the standard-treatment group) enrolled from February 2019 through December 2021, 5803 (45.3%) were women; the mean (±SD) age of the patients was 63.8±7.5 years. At 1 year of follow-up, the mean systolic blood pressure was 121.6 mm Hg (median, 118.3 mm Hg) in the intensive-treatment group and 133.2 mm Hg (median, 135.0 mm Hg) in the standard-treatment group. During a median follow-up of 4.2 years, primary-outcome events occurred in 393 patients (1.65 events per 100 person-years) in the intensive-treatment group and 492 patients (2.09 events per 100 person-years) in the standard-treatment group (hazard ratio, 0.79; 95% confidence interval, 0.69 to 0.90; P<0.001). The incidence of serious adverse events was similar in the treatment groups. However, symptomatic hypotension and hyperkalemia occurred more frequently in the intensive-treatment group than in the standard-treatment group.
Conclusions: Among patients with type 2 diabetes, the incidence of major cardiovascular events was significantly lower with intensive treatment targeting a systolic blood pressure of less than 120 mm Hg than with standard treatment targeting a systolic blood pressure of less than 140 mm Hg. (Funded by the National Key Research and Development Program of the Ministry of Science and Technology of China and others; BPROAD ClinicalTrials.gov number, NCT03808311.).
{"title":"Intensive Blood-Pressure Control in Patients with Type 2 Diabetes.","authors":"Yufang Bi, Mian Li, Yan Liu, Tingzhi Li, Jieli Lu, Peng Duan, Fengmei Xu, Qijuan Dong, Ailiang Wang, Tiange Wang, Ruizhi Zheng, Yuhong Chen, Min Xu, Xiaohu Wang, Xinhuan Zhang, Yanbo Niu, Zhiqiang Kang, Chunru Lu, Jing Wang, Xinwen Qiu, An Wang, Shujing Wu, Jingya Niu, Jingya Wang, Zhiyun Zhao, Huanfeng Pan, Xiaohua Yang, Xiaohong Niu, Shuguang Pang, Xiaoliang Zhang, Yuancheng Dai, Qin Wan, Shihong Chen, Qidong Zheng, Shaoping Dai, Juan Deng, Leshan Liu, Guixia Wang, Huiqi Zhu, Weidong Tang, Haixia Liu, Zhenfang Guo, Guang Ning, Jiang He, Yu Xu, Weiqing Wang","doi":"10.1056/NEJMoa2412006","DOIUrl":"10.1056/NEJMoa2412006","url":null,"abstract":"<p><strong>Background: </strong>Effective targets for systolic blood-pressure control in patients with type 2 diabetes are unclear.</p><p><strong>Methods: </strong>We enrolled patients 50 years of age or older with type 2 diabetes, elevated systolic blood pressure, and an increased risk of cardiovascular disease at 145 clinical sites across China. Patients were randomly assigned to receive intensive treatment that targeted a systolic blood pressure of less than 120 mm Hg or standard treatment that targeted a systolic blood pressure of less than 140 mm Hg for up to 5 years. The primary outcome was a composite of nonfatal stroke, nonfatal myocardial infarction, treatment or hospitalization for heart failure, or death from cardiovascular causes. Multiple imputation was used for missing outcome data, with an assumption that the data were missing at random.</p><p><strong>Results: </strong>Of 12,821 patients (6414 patients in the intensive-treatment group and 6407 in the standard-treatment group) enrolled from February 2019 through December 2021, 5803 (45.3%) were women; the mean (±SD) age of the patients was 63.8±7.5 years. At 1 year of follow-up, the mean systolic blood pressure was 121.6 mm Hg (median, 118.3 mm Hg) in the intensive-treatment group and 133.2 mm Hg (median, 135.0 mm Hg) in the standard-treatment group. During a median follow-up of 4.2 years, primary-outcome events occurred in 393 patients (1.65 events per 100 person-years) in the intensive-treatment group and 492 patients (2.09 events per 100 person-years) in the standard-treatment group (hazard ratio, 0.79; 95% confidence interval, 0.69 to 0.90; P<0.001). The incidence of serious adverse events was similar in the treatment groups. However, symptomatic hypotension and hyperkalemia occurred more frequently in the intensive-treatment group than in the standard-treatment group.</p><p><strong>Conclusions: </strong>Among patients with type 2 diabetes, the incidence of major cardiovascular events was significantly lower with intensive treatment targeting a systolic blood pressure of less than 120 mm Hg than with standard treatment targeting a systolic blood pressure of less than 140 mm Hg. (Funded by the National Key Research and Development Program of the Ministry of Science and Technology of China and others; BPROAD ClinicalTrials.gov number, NCT03808311.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142648992","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}
Pub Date : 2024-11-14Epub Date: 2024-11-09DOI: 10.1056/NEJMp2410910
Katherine A Nash, Joanna Perdomo, Heather E Hsu
{"title":"Health Equity Rounds - Root-Cause and Solutions-Oriented Discussions of Medical Racism.","authors":"Katherine A Nash, Joanna Perdomo, Heather E Hsu","doi":"10.1056/NEJMp2410910","DOIUrl":"https://doi.org/10.1056/NEJMp2410910","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 19","pages":"1763-1765"},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632667","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}
Meron Teklu, Anand Vaidya, Merve Yonar, June-Ho Kim, Edy Y Kim
{"title":"Out of Breath.","authors":"Meron Teklu, Anand Vaidya, Merve Yonar, June-Ho Kim, Edy Y Kim","doi":"10.1056/NEJMimc2400356","DOIUrl":"https://doi.org/10.1056/NEJMimc2400356","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 19","pages":"e43"},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632678","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}
Pub Date : 2024-11-14Epub Date: 2024-11-09DOI: 10.1056/NEJMp2409709
Sarah Revak, Karen Cuttin, Bianca Nfonoyim Bernhard, Shelby H Davies
{"title":"The Menstrual Health Equity Initiative - Access to Menstrual Products for People Experiencing Homelessness.","authors":"Sarah Revak, Karen Cuttin, Bianca Nfonoyim Bernhard, Shelby H Davies","doi":"10.1056/NEJMp2409709","DOIUrl":"https://doi.org/10.1056/NEJMp2409709","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 19","pages":"1765-1767"},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632681","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}
Pub Date : 2024-11-14Epub Date: 2024-09-15DOI: 10.1056/NEJMoa2408154
Thomas Powles, James W F Catto, Matthew D Galsky, Hikmat Al-Ahmadie, Joshua J Meeks, Hiroyuki Nishiyama, Toan Quang Vu, Lorenzo Antonuzzo, Pawel Wiechno, Vagif Atduev, Ariel G Kann, Tae-Hwan Kim, Cristina Suárez, Chao-Hsiang Chang, Florian Roghmann, Mustafa Özgüroğlu, Bernhard J Eigl, Niara Oliveira, Tomas Buchler, Moran Gadot, Yousef Zakharia, Jon Armstrong, Ashok Gupta, Stephan Hois, Michiel S van der Heijden
Background: Neoadjuvant chemotherapy followed by radical cystectomy is the standard treatment for cisplatin-eligible patients with muscle-invasive bladder cancer. Adding perioperative immunotherapy may improve outcomes.
Methods: In this phase 3, open-label, randomized trial, we assigned, in a 1:1 ratio, cisplatin-eligible patients with muscle-invasive bladder cancer to receive neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for four cycles, followed by radical cystectomy and adjuvant durvalumab every 4 weeks for eight cycles (durvalumab group), or to receive neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (comparison group). Event-free survival was one of two primary end points. Overall survival was the key secondary end point.
Results: In total, 533 patients were assigned to the durvalumab group and 530 to the comparison group. The estimated event-free survival at 24 months was 67.8% (95% confidence interval [CI], 63.6 to 71.7) in the durvalumab group and 59.8% (95% CI, 55.4 to 64.0) in the comparison group (hazard ratio for progression, recurrence, not undergoing radical cystectomy, or death from any cause, 0.68; 95% CI, 0.56 to 0.82; P<0.001 by stratified log-rank test). The estimated overall survival at 24 months was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab group and 75.2% (95% CI, 71.3 to 78.8) in the comparison group (hazard ratio for death, 0.75; 95% CI, 0.59 to 0.93; P = 0.01 by stratified log-rank test). Treatment-related adverse events of grade 3 or 4 in severity occurred in 40.6% of the patients in the durvalumab group and in 40.9% of those in the comparison group; treatment-related adverse events leading to death occurred in 0.6% in each group. Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group.
Conclusions: Perioperative durvalumab plus neoadjuvant chemotherapy led to significant improvements in event-free survival and overall survival as compared with neoadjuvant chemotherapy alone. (Funded by AstraZeneca; NIAGARA ClinicalTrials.gov number, NCT03732677; EudraCT number, 2018-001811-59.).
{"title":"Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer.","authors":"Thomas Powles, James W F Catto, Matthew D Galsky, Hikmat Al-Ahmadie, Joshua J Meeks, Hiroyuki Nishiyama, Toan Quang Vu, Lorenzo Antonuzzo, Pawel Wiechno, Vagif Atduev, Ariel G Kann, Tae-Hwan Kim, Cristina Suárez, Chao-Hsiang Chang, Florian Roghmann, Mustafa Özgüroğlu, Bernhard J Eigl, Niara Oliveira, Tomas Buchler, Moran Gadot, Yousef Zakharia, Jon Armstrong, Ashok Gupta, Stephan Hois, Michiel S van der Heijden","doi":"10.1056/NEJMoa2408154","DOIUrl":"10.1056/NEJMoa2408154","url":null,"abstract":"<p><strong>Background: </strong>Neoadjuvant chemotherapy followed by radical cystectomy is the standard treatment for cisplatin-eligible patients with muscle-invasive bladder cancer. Adding perioperative immunotherapy may improve outcomes.</p><p><strong>Methods: </strong>In this phase 3, open-label, randomized trial, we assigned, in a 1:1 ratio, cisplatin-eligible patients with muscle-invasive bladder cancer to receive neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for four cycles, followed by radical cystectomy and adjuvant durvalumab every 4 weeks for eight cycles (durvalumab group), or to receive neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (comparison group). Event-free survival was one of two primary end points. Overall survival was the key secondary end point.</p><p><strong>Results: </strong>In total, 533 patients were assigned to the durvalumab group and 530 to the comparison group. The estimated event-free survival at 24 months was 67.8% (95% confidence interval [CI], 63.6 to 71.7) in the durvalumab group and 59.8% (95% CI, 55.4 to 64.0) in the comparison group (hazard ratio for progression, recurrence, not undergoing radical cystectomy, or death from any cause, 0.68; 95% CI, 0.56 to 0.82; P<0.001 by stratified log-rank test). The estimated overall survival at 24 months was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab group and 75.2% (95% CI, 71.3 to 78.8) in the comparison group (hazard ratio for death, 0.75; 95% CI, 0.59 to 0.93; P = 0.01 by stratified log-rank test). Treatment-related adverse events of grade 3 or 4 in severity occurred in 40.6% of the patients in the durvalumab group and in 40.9% of those in the comparison group; treatment-related adverse events leading to death occurred in 0.6% in each group. Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group.</p><p><strong>Conclusions: </strong>Perioperative durvalumab plus neoadjuvant chemotherapy led to significant improvements in event-free survival and overall survival as compared with neoadjuvant chemotherapy alone. (Funded by AstraZeneca; NIAGARA ClinicalTrials.gov number, NCT03732677; EudraCT number, 2018-001811-59.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1773-1786"},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142301192","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}
T Bernard Kinane, Evan J Zucker, Katherine A Sparger, Cassandra M Kelleher, Angela R Shih
{"title":"Case 35-2024: A Newborn with Hypoxemia and a Lung Opacity.","authors":"T Bernard Kinane, Evan J Zucker, Katherine A Sparger, Cassandra M Kelleher, Angela R Shih","doi":"10.1056/NEJMcpc2402487","DOIUrl":"https://doi.org/10.1056/NEJMcpc2402487","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 19","pages":"1838-1846"},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632659","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}
Timothy G Ferris, Jennifer Dixon, David Blumenthal
{"title":"Lessons from England's National Health Service.","authors":"Timothy G Ferris, Jennifer Dixon, David Blumenthal","doi":"10.1056/NEJMhpr2407495","DOIUrl":"https://doi.org/10.1056/NEJMhpr2407495","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 19","pages":"1852-1859"},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632674","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}
John H Stone, Arezou Khosroshahi, Wen Zhang, Emanuel Della Torre, Kazuichi Okazaki, Yoshiya Tanaka, J Matthias Löhr, Nicolas Schleinitz, Lingli Dong, Hisanori Umehara, Marco Lanzillotta, Zachary S Wallace, Mikael Ebbo, George J Webster, Fernando Martinez Valle, Manu K Nayar, Cory A Perugino, Vinciane Rebours, Xinxin Dong, Yanping Wu, Qing Li, Nishi Rampal, Daniel Cimbora, Emma L Culver
Background: IgG4-related disease is a multiorgan, relapsing, fibroinflammatory, immune-mediated disorder with no approved therapy. Inebilizumab targets and depletes CD19+ B cells and may be effective for treating patients with IgG4-related disease.
Methods: In this phase 3, multicenter, double-blind, randomized, placebo-controlled trial, adults with active IgG4-related disease underwent randomization in a 1:1 ratio to receive inebilizumab (300-mg intravenous infusions on days 1 and 15 and week 26) or placebo for a 52-week treatment period. Participants in both groups received identical glucocorticoid tapers. Glucocorticoids were allowed to treat disease flares, but background immunosuppressants were not permitted. The primary end point was the first treated, adjudicated disease flare during the treatment period, assessed in a time-to-event analysis. Key secondary end points were the annualized flare rate and treatment-free and glucocorticoid-free complete remission.
Results: A total of 135 participants with IgG4-related disease underwent randomization: 68 participants were assigned to receive inebilizumab and 67 were assigned to receive placebo. Treatment with inebilizumab reduced flare risk; 7 participants (10%) in the inebilizumab group had at least one flare, as compared with 40 participants (60%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.06 to 0.28; P<0.001). The annualized flare rate was lower with inebilizumab than with placebo (rate ratio, 0.14; 95% CI, 0.06 to 0.31; P<0.001). More participants in the inebilizumab group than in the placebo group had flare-free, treatment-free complete remission (odds ratio, 4.68; 95% CI, 2.21 to 9.91; P<0.001) and flare-free, glucocorticoid-free complete remission (odds ratio, 4.96; 95% CI, 2.34 to 10.52; P<0.001). Serious adverse events occurred during the treatment period in 12 of the participants (18%) who received inebilizumab and 6 of the participants (9%) who received placebo.
Conclusions: Inebilizumab reduced the risk of flares of IgG4-related disease and increased the likelihood of flare-free complete remission at 1 year, confirming the role of CD19-targeted B-cell depletion as a potential treatment for IgG4-related disease. (Funded by Amgen; MITIGATE ClinicalTrials.gov number, NCT04540497.).
背景IgG4相关疾病是一种多器官、复发性、纤维炎症性、免疫介导的疾病,目前尚无获批疗法。伊奈珠单抗能靶向消耗 CD19+ B 细胞,可能对治疗 IgG4 相关疾病患者有效:在这项3期、多中心、双盲、随机、安慰剂对照试验中,患有活动性IgG4相关疾病的成人按1:1的比例随机接受伊奈珠单抗(第1天、第15天和第26周静脉注射300毫克)或安慰剂,治疗期为52周。两组患者均接受相同的糖皮质激素减量治疗。允许使用糖皮质激素治疗疾病复发,但不允许使用背景免疫抑制剂。主要终点是在治疗期间首次出现经治疗和判定的疾病复发,以时间到事件分析法进行评估。主要次要终点是年复发率以及无治疗和无糖皮质激素完全缓解率:共有135名IgG4相关疾病患者接受了随机分配:68名参与者被分配接受伊维单抗治疗,67名参与者被分配接受安慰剂治疗。伊维单抗治疗降低了复发风险;伊维单抗组有7人(10%)至少复发一次,而安慰剂组有40人(60%)复发(危险比为0.13;95%置信区间[CI]为0.06至0.28;PConclusions.):伊尼单抗降低了IgG4相关疾病复发的风险,并增加了1年后无复发完全缓解的可能性,证实了CD19靶向B细胞清除作为IgG4相关疾病潜在治疗方法的作用。(由安进公司资助;MITIGATE ClinicalTrials.gov 编号:NCT04540497)。
{"title":"Inebilizumab for Treatment of IgG4-Related Disease.","authors":"John H Stone, Arezou Khosroshahi, Wen Zhang, Emanuel Della Torre, Kazuichi Okazaki, Yoshiya Tanaka, J Matthias Löhr, Nicolas Schleinitz, Lingli Dong, Hisanori Umehara, Marco Lanzillotta, Zachary S Wallace, Mikael Ebbo, George J Webster, Fernando Martinez Valle, Manu K Nayar, Cory A Perugino, Vinciane Rebours, Xinxin Dong, Yanping Wu, Qing Li, Nishi Rampal, Daniel Cimbora, Emma L Culver","doi":"10.1056/NEJMoa2409712","DOIUrl":"https://doi.org/10.1056/NEJMoa2409712","url":null,"abstract":"<p><strong>Background: </strong>IgG4-related disease is a multiorgan, relapsing, fibroinflammatory, immune-mediated disorder with no approved therapy. Inebilizumab targets and depletes CD19+ B cells and may be effective for treating patients with IgG4-related disease.</p><p><strong>Methods: </strong>In this phase 3, multicenter, double-blind, randomized, placebo-controlled trial, adults with active IgG4-related disease underwent randomization in a 1:1 ratio to receive inebilizumab (300-mg intravenous infusions on days 1 and 15 and week 26) or placebo for a 52-week treatment period. Participants in both groups received identical glucocorticoid tapers. Glucocorticoids were allowed to treat disease flares, but background immunosuppressants were not permitted. The primary end point was the first treated, adjudicated disease flare during the treatment period, assessed in a time-to-event analysis. Key secondary end points were the annualized flare rate and treatment-free and glucocorticoid-free complete remission.</p><p><strong>Results: </strong>A total of 135 participants with IgG4-related disease underwent randomization: 68 participants were assigned to receive inebilizumab and 67 were assigned to receive placebo. Treatment with inebilizumab reduced flare risk; 7 participants (10%) in the inebilizumab group had at least one flare, as compared with 40 participants (60%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.06 to 0.28; P<0.001). The annualized flare rate was lower with inebilizumab than with placebo (rate ratio, 0.14; 95% CI, 0.06 to 0.31; P<0.001). More participants in the inebilizumab group than in the placebo group had flare-free, treatment-free complete remission (odds ratio, 4.68; 95% CI, 2.21 to 9.91; P<0.001) and flare-free, glucocorticoid-free complete remission (odds ratio, 4.96; 95% CI, 2.34 to 10.52; P<0.001). Serious adverse events occurred during the treatment period in 12 of the participants (18%) who received inebilizumab and 6 of the participants (9%) who received placebo.</p><p><strong>Conclusions: </strong>Inebilizumab reduced the risk of flares of IgG4-related disease and increased the likelihood of flare-free complete remission at 1 year, confirming the role of CD19-targeted B-cell depletion as a potential treatment for IgG4-related disease. (Funded by Amgen; MITIGATE ClinicalTrials.gov number, NCT04540497.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":""},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632649","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":"Activity of Research-Grade Pemivibart against Recent SARS-CoV-2 JN.1 Sublineages.","authors":"Qian Wang, Yicheng Guo, Jerren Ho, David D Ho","doi":"10.1056/NEJMc2410203","DOIUrl":"https://doi.org/10.1056/NEJMc2410203","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 19","pages":"1863-1864"},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632655","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":"Immunobridging for Pemivibart, a Monoclonal Antibody for Prevention of Covid-19.","authors":"Pete Schmidt, Yong Li, Myra Popejoy","doi":"10.1056/NEJMc2404555","DOIUrl":"https://doi.org/10.1056/NEJMc2404555","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"391 19","pages":"1860-1862"},"PeriodicalIF":96.2,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142632669","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}