Richard A Furie, Brad H Rovin, William F Pendergraft
{"title":"Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. Reply.","authors":"Richard A Furie, Brad H Rovin, William F Pendergraft","doi":"10.1056/NEJMc2506672","DOIUrl":"https://doi.org/10.1056/NEJMc2506672","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"393 4","pages":"410"},"PeriodicalIF":96.2,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700373","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}
Nicaise Ndembi,Morenike O Folayan,Salim S Abdool Karim
{"title":"Evolving Epidemiology of Mpox in Africa in 2024. Reply.","authors":"Nicaise Ndembi,Morenike O Folayan,Salim S Abdool Karim","doi":"10.1056/nejmc2503635","DOIUrl":"https://doi.org/10.1056/nejmc2503635","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"109 1","pages":"414"},"PeriodicalIF":158.5,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693369","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":"Ivermectin to Control Malaria - A Cluster-Randomized Trial.","authors":"Carlos Chaccour,Marta Maia,Mercy Kariuki,Paula Ruiz-Castillo,Caroline Wanjiku,Lydia Kasiwa,Aurelia Brazeal,Aina Casellas,Mwanajuma Ngama,Truphena Onyango,Eldo Elobolobo,Karisa Kazungu,Mary Mael,Winnie Wangari,Khadija Nuru,Rachel Otuko,Almudena Sanz,Isaac Ringera,Allan Matano,Starford Mitora,Marta Ribes,Joe Brew,Nika Gorski,Patricia Nicolas,Sara Stanulovic,Isaiah Omondi,Joanna Furnival-Adams,Laura Túnez,Jamal Mbarak,Vegovito Vegove,Esther Yaa,Shadrack Mramba,Yegon Kibet,Naomi Nyambura,Charles Rotich,Scholastica Wanjiru,Musa Vura,Faith Wanjiku,Leslie Sam,Lisa Collins,Kang Xia,Felix Hammann,Francisco Saúte,Matthew Rudd,Cassidy Rist,Caroline Jones,Joseph Mwangangi,N Regina Rabinovich","doi":"10.1056/nejmoa2411262","DOIUrl":"https://doi.org/10.1056/nejmoa2411262","url":null,"abstract":"BACKGROUNDMalaria control and elimination is threatened by the spread of insecticide resistance and behavioral adaptation of vectors. Whether mass administration of ivermectin, a broad-spectrum antiparasitic drug that also kills mosquitoes feeding on treated persons, can reduce malaria transmission is unclear.METHODSWe conducted a cluster-randomized trial in Kwale, a county in coastal Kenya in which malaria is highly endemic and coverage and use of insecticide-treated nets are high. Clusters of household areas were randomly assigned in a 1:1 ratio to receive mass administration of ivermectin (400 μg per kilogram of body weight) or albendazole (400 mg, active control) once a month for 3 consecutive months at the beginning of the \"short rains\" season. Children 5 to 15 years of age were tested for malaria infection monthly for 6 months after the first round of treatment. The two primary outcomes were the cumulative incidence of malaria infection (assessed among children 5 to 15 years of age) and of adverse events (assessed among all eligible participants). Analyses were performed with generalized estimating equations in accordance with the intention-to-treat principle.RESULTSA total of 84 clusters comprising 28,932 eligible participants underwent randomization. The baseline characteristics of the participants were similar in the trial groups. Six months after the first round of treatment, the incidence of malaria infection was 2.20 per child-year at risk in the ivermectin group and 2.66 per child-year at risk in the albendazole group; the adjusted incidence rate ratio (ivermectin vs. albendazole) was 0.74 (95% confidence interval [CI], 0.58 to 0.95, P = 0.02). The incidence of serious adverse events per 100 treatments did not differ significantly between the trial groups (incidence rate ratio, 0.63; 95% CI, 0.21 to 1.91).CONCLUSIONSAmong children 5 to 15 years of age who were living in an area with high coverage and use of bed nets, ivermectin, administered once a month for 3 consecutive months, resulted in a 26% lower incidence of malaria infection than albendazole. No safety concerns were identified. (Funded by Unitaid; BOHEMIA ClinicalTrials.gov number, NCT04966702; Pan African Clinical Trial Registry number, PACTR202106695877303.).","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"17 1","pages":"362-375"},"PeriodicalIF":158.5,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693373","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}
Giannis Mountzios, Longhua Sun, Byoung Chul Cho, Umut Demirci, Sofia Baka, Mahmut Gümüş, Antonio Lugini, Bo Zhu, Yan Yu, Ippokratis Korantzis, Ji-Youn Han, Tudor-Eliade Ciuleanu, Myung-Ju Ahn, Pedro Rocha, Julien Mazières, Sally C M Lau, Martin Schuler, Fiona Blackhall, Tatsuya Yoshida, Taofeek K Owonikoko, Luis Paz-Ares, Tony Jiang, Ali Hamidi, Diana Gauto, Gonzalo Recondo, Charles M Rudin
{"title":"Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy.","authors":"Giannis Mountzios, Longhua Sun, Byoung Chul Cho, Umut Demirci, Sofia Baka, Mahmut Gümüş, Antonio Lugini, Bo Zhu, Yan Yu, Ippokratis Korantzis, Ji-Youn Han, Tudor-Eliade Ciuleanu, Myung-Ju Ahn, Pedro Rocha, Julien Mazières, Sally C M Lau, Martin Schuler, Fiona Blackhall, Tatsuya Yoshida, Taofeek K Owonikoko, Luis Paz-Ares, Tony Jiang, Ali Hamidi, Diana Gauto, Gonzalo Recondo, Charles M Rudin","doi":"10.1056/NEJMoa2502099","DOIUrl":"10.1056/NEJMoa2502099","url":null,"abstract":"<p><strong>Background: </strong>Tarlatamab, a bispecific delta-like ligand 3-directed T-cell engager immunotherapy, received accelerated approval for the treatment of patients with previously treated small-cell lung cancer. Whether tarlatamab is more effective than chemotherapy in the treatment of patients whose small-cell lung cancer has progressed during or after initial platinum-based chemotherapy is not known.</p><p><strong>Methods: </strong>We conducted a multinational, phase 3, open-label trial to compare tarlatamab with chemotherapy as second-line treatment in patients with small-cell lung cancer whose disease had progressed during or after platinum-based chemotherapy. Patients were randomly assigned to receive tarlatamab or chemotherapy (topotecan, lurbinectedin, or amrubicin). The primary end point was overall survival. Key secondary end points were investigator-assessed progression-free survival and patient-reported outcomes. Results of the prespecified interim analysis (data-cutoff date, January 29, 2025) are reported.</p><p><strong>Results: </strong>A total of 509 patients were randomly assigned to receive tarlatamab (254 patients) or chemotherapy (255 patients). Treatment with tarlatamab resulted in significantly longer overall survival than chemotherapy (median, 13.6 months [95% confidence interval {CI}, 11.1 to not reached] vs. 8.3 months [95% CI, 7.0 to 10.2]; stratified hazard ratio for death, 0.60; 95% CI, 0.47 to 0.77; P<0.001). Tarlatamab treatment also had a significant benefit with respect to progression-free survival and cancer-related dyspnea and cough as compared with chemotherapy. The incidence of adverse events of grade 3 or higher was lower with tarlatamab than with chemotherapy (54% vs. 80%), as was the incidence of adverse events resulting in treatment discontinuation (5% vs. 12%).</p><p><strong>Conclusions: </strong>Treatment with tarlatamab led to longer overall survival than chemotherapy among patients with small-cell lung cancer whose disease had progressed during or after platinum-based chemotherapy. (Funded by Amgen; DeLLphi-304 ClinicalTrials.gov number, NCT05740566.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"349-361"},"PeriodicalIF":96.2,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144200791","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}
Nicaise Ndembi, Morenike O Folayan, Salim S Abdool Karim
{"title":"Evolving Epidemiology of Mpox in Africa in 2024. Reply.","authors":"Nicaise Ndembi, Morenike O Folayan, Salim S Abdool Karim","doi":"10.1056/NEJMc2503635","DOIUrl":"https://doi.org/10.1056/NEJMc2503635","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"393 4","pages":"414"},"PeriodicalIF":96.2,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700376","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}
Harleen K Marwah, Ilse K Luirink, Michele Mietus-Snyder
{"title":"Statin Therapy for Children.","authors":"Harleen K Marwah, Ilse K Luirink, Michele Mietus-Snyder","doi":"10.1056/NEJMclde2414458","DOIUrl":"https://doi.org/10.1056/NEJMclde2414458","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"393 4","pages":"405-407"},"PeriodicalIF":96.2,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144700380","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":"Lead Contamination in Milwaukee Schools - The Latest Episode in an Ongoing Toxic Pandemic.","authors":"Marty S Kanarek","doi":"10.1056/nejmp2506801","DOIUrl":"https://doi.org/10.1056/nejmp2506801","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"696 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693506","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":"Preventive Care at the Supreme Court.","authors":"Nicholas Bagley","doi":"10.1056/nejmp2506684","DOIUrl":"https://doi.org/10.1056/nejmp2506684","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"20 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693377","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 Promise of Real-World Data for Research - What Are We Missing?","authors":"Ali B Abbasi,Lesley H Curtis,Robert M Califf","doi":"10.1056/nejmp2416479","DOIUrl":"https://doi.org/10.1056/nejmp2416479","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"143 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144669550","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}
Yelena Y Janjigian, Salah-Eddin Al-Batran, Zev A Wainberg, Kei Muro, Daniela Molena, Eric Van Cutsem, Woo Jin Hyung, Lucjan Wyrwicz, Do-Youn Oh, Takeshi Omori, Markus Moehler, Marcelo Garrido, Sulene C S Oliveira, Moishe Liberman, Victor Castro Oliden, Elizabeth C Smyth, Alexander Stein, Mehmet Bilici, Maria Lorena Alvarenga, Vadim Kozlov, Fernando Rivera, Akihito Kawazoe, Olivier Serrano, Eric Heilbron, Alejandra Negro, John F Kurland, Josep Tabernero
{"title":"Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer.","authors":"Yelena Y Janjigian, Salah-Eddin Al-Batran, Zev A Wainberg, Kei Muro, Daniela Molena, Eric Van Cutsem, Woo Jin Hyung, Lucjan Wyrwicz, Do-Youn Oh, Takeshi Omori, Markus Moehler, Marcelo Garrido, Sulene C S Oliveira, Moishe Liberman, Victor Castro Oliden, Elizabeth C Smyth, Alexander Stein, Mehmet Bilici, Maria Lorena Alvarenga, Vadim Kozlov, Fernando Rivera, Akihito Kawazoe, Olivier Serrano, Eric Heilbron, Alejandra Negro, John F Kurland, Josep Tabernero","doi":"10.1056/NEJMoa2503701","DOIUrl":"10.1056/NEJMoa2503701","url":null,"abstract":"<p><strong>Background: </strong>Perioperative FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) is a standard therapy for resectable gastric and gastroesophageal junction adenocarcinomas, but recurrence rates remain high. Immunotherapy plus chemotherapy may improve outcomes.</p><p><strong>Methods: </strong>In a phase 3, multinational, double-blind, randomized trial, we assigned participants with resectable gastric or gastroesophageal junction adenocarcinoma, in a 1:1 ratio, to receive durvalumab at a dose of 1500 mg or placebo every 4 weeks plus FLOT for 4 cycles (2 cycles each of neoadjuvant and adjuvant therapy), followed by durvalumab or placebo every 4 weeks for 10 cycles. The primary end point was event-free survival; secondary end points included overall survival and pathological complete response.</p><p><strong>Results: </strong>A total of 474 participants were randomly assigned to the durvalumab group, and 474 to the placebo group (median follow-up, 31.5 months; interquartile range, 26.7 to 36.6). Two-year event-free survival (Kaplan-Meier estimate) was 67.4% among the participants in the durvalumab group and 58.5% among those in the placebo group (hazard ratio for event or death, 0.71; 95% confidence interval [CI], 0.58 to 0.86; P<0.001). Two-year overall survival was 75.7% in the durvalumab group and 70.4% in the placebo group (piecewise hazard ratio for death during months 0 to 12, 0.99 [95% CI, 0.70 to 1.39], and during the period from month 12 onward, 0.67 [95% CI, 0.50 to 0.90]; P = 0.03 by a stratified log-rank test [exceeding the significance threshold of P<0.0001]). The percentage of participants with a pathological complete response was 19.2% in the durvalumab group and 7.2% in the placebo group (relative risk, 2.69 [95% CI, 1.86 to 3.90]). Adverse events with a maximum grade of 3 or 4 were reported in 340 participants (71.6%) in the durvalumab group and in 334 (71.2%) in the placebo group. The percentage of participants with delayed surgery was 10.1% and 10.8%, respectively, and the percentage with delayed initiation of adjuvant treatment was 2.3% and 4.6%.</p><p><strong>Conclusions: </strong>Perioperative durvalumab plus FLOT led to significantly better event-free survival outcomes than FLOT alone among participants with resectable gastric or gastroesophageal junction adenocarcinoma. (Funded by AstraZeneca; MATTERHORN ClinicalTrials.gov number, NCT04592913.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"217-230"},"PeriodicalIF":96.2,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144200789","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}