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Phase 2 Trial of Icotrokinra for Patients with Ulcerative Colitis. Icotrokinra治疗溃疡性结肠炎的2期临床试验
IF 84.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-15 DOI: 10.1056/NEJMoa2604435
Maria T Abreu, Britta Siegmund, Lindsey Surace, Ngozi Erondu, Minhu Chen, Karen Chachu, Edouard Louis, Katsuyoshi Matsuoka, Jimmy Limdi, Edmund Arthur, Nicole Houck, Colleen Marano, Marion L Vetter, Bin Zou, Joyce Zhan, Mary Ellen Frustaci, Arun K Kannan, Grazyna Rydzewska, Edward V Loftus, Vipul Jairath
{"title":"Phase 2 Trial of Icotrokinra for Patients with Ulcerative Colitis.","authors":"Maria T Abreu, Britta Siegmund, Lindsey Surace, Ngozi Erondu, Minhu Chen, Karen Chachu, Edouard Louis, Katsuyoshi Matsuoka, Jimmy Limdi, Edmund Arthur, Nicole Houck, Colleen Marano, Marion L Vetter, Bin Zou, Joyce Zhan, Mary Ellen Frustaci, Arun K Kannan, Grazyna Rydzewska, Edward V Loftus, Vipul Jairath","doi":"10.1056/NEJMoa2604435","DOIUrl":"https://doi.org/10.1056/NEJMoa2604435","url":null,"abstract":"<p><strong>Background: </strong>Monoclonal antibodies targeting the interleukin-23 pathway are effective in treating inflammatory bowel disease. However, these therapies must be administered intravenously or by subcutaneous injection.</p><p><strong>Methods: </strong>We conducted a phase 2b, double-blind, randomized trial of oral icotrokinra, a peptide that blocks the interleukin-23 receptor, in adults with moderately to severely active ulcerative colitis. Participants were assigned to receive icotrokinra at a once-daily dose of 400 mg, 200 mg, or 100 mg or placebo. The primary end point was clinical response at week 12. Secondary end points included clinical remission, remission of symptoms, and endoscopic improvement at week 12.</p><p><strong>Results: </strong>A total of 252 participants underwent randomization: 63 were assigned to the 400-mg group, 62 to the 200-mg group, 64 to the 100-mg group, and 63 to the placebo group. All the doses of icotrokinra were superior to placebo with respect to a clinical response at week 12, which occurred in 63% of the participants in the 400-mg group, 58% in the 200-mg group, and 55% in the 100-mg group, as compared with 27% in the placebo group (P<0.001 for all comparisons with placebo). The percentage of participants with clinical remission at week 12 was also significantly higher in the 400-mg group than in the placebo group (30% vs. 11%, P = 0.006), as were the percentage of participants with symptomatic remission (46% vs. 19%, P<0.001) and the percentage of participants with endoscopic improvement (37% vs. 14%, P = 0.002). Clinical remission at week 12 occurred in 24% of the participants in the 200-mg group (P = 0.054 for the comparison with placebo); in accordance with the fixed-sequence testing procedure to account for multiple comparisons, no further formal testing of secondary end points was conducted. Through week 28, the percentage of participants with adverse events was 60% in the 400-mg group, 66% in the 200-mg group, 66% in the 100-mg group, and 62% in the placebo group. For serious adverse events, the percentages were 2%, 5%, 0%, and 10%, respectively.</p><p><strong>Conclusions: </strong>Among participants with moderately to severely active ulcerative colitis, a clinical response at week 12 was significantly more common with once-daily oral icotrokinra at each of three tested doses than with placebo. (Funded by Johnson & Johnson; ANTHEM-UC ClinicalTrials.gov number, NCT06049017.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"395 15","pages":"1495-1504"},"PeriodicalIF":84.5,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186308","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}
引用次数: 0
Obinutuzumab in Active Systemic Lupus Erythematosus. Obinutuzumab治疗活动性系统性红斑狼疮。
IF 84.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-15 DOI: 10.1056/NEJMc2610854
Omer N Pamuk
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引用次数: 0
Long-Acting HIV Therapy in African Adults with Adherence Challenges. 长效艾滋病治疗在非洲成人坚持挑战。
IF 84.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-15 DOI: 10.1056/NEJMoa2518753
Fiona V Cresswell, Jonathan Kitonsa, Claire Norcross, Victoria Tumusiime, Loice Achieng Ombajo, Nigel Garrett, Sheetal Kassim, Noela C Owarwo, Eva A Laker Odongpiny, Ibrahim Yawe, Sharana Mahomed, Henry Mugerwa, Paddy L Kafeero, Joseph Nkuranga, Ubaldo Bahemuka, Jane Nabbuto, Violet Ankunda, Phiona Nabaggala, Charles Ogwang, Geofrey Kimbugwe, Ayoub Kakande, Upasna Singh, Dorothie van der Vendt, Arnold Onyango, Eve Koile, David S Lawrence, Awhonukeh Idahosa, Veerle van Eygen, Fafa Addo Boateng, Ingrid Eshun-Wilsonova, Daniel J Grint, Eugene Ruzagira
{"title":"Long-Acting HIV Therapy in African Adults with Adherence Challenges.","authors":"Fiona V Cresswell, Jonathan Kitonsa, Claire Norcross, Victoria Tumusiime, Loice Achieng Ombajo, Nigel Garrett, Sheetal Kassim, Noela C Owarwo, Eva A Laker Odongpiny, Ibrahim Yawe, Sharana Mahomed, Henry Mugerwa, Paddy L Kafeero, Joseph Nkuranga, Ubaldo Bahemuka, Jane Nabbuto, Violet Ankunda, Phiona Nabaggala, Charles Ogwang, Geofrey Kimbugwe, Ayoub Kakande, Upasna Singh, Dorothie van der Vendt, Arnold Onyango, Eve Koile, David S Lawrence, Awhonukeh Idahosa, Veerle van Eygen, Fafa Addo Boateng, Ingrid Eshun-Wilsonova, Daniel J Grint, Eugene Ruzagira","doi":"10.1056/NEJMoa2518753","DOIUrl":"https://doi.org/10.1056/NEJMoa2518753","url":null,"abstract":"<p><strong>Background: </strong>In eastern and southern Africa, approximately 1 million people living with human immunodeficiency virus (HIV) and receiving oral therapy do not have viral suppression because of adherence challenges.</p><p><strong>Methods: </strong>We conducted a phase 3b, open-label, randomized trial to compare long-acting injectable cabotegravir plus rilpivirine with oral dolutegravir-based therapy among adults with virally suppressed HIV type 1 (viral load, <200 copies per milliliter) and suboptimal adherence or care engagement. The participants were assigned in a 1:1 ratio to receive intramuscular injections of cabotegravir (600 mg) plus rilpivirine (900 mg) every 8 weeks, with the first two injection visits occurring 4 weeks apart, or to continue daily oral dolutegravir-based therapy; baseline drug-resistance testing was not performed. The primary end point was a viral load of less than 50 copies per milliliter at week 48; noninferiority was assessed with a margin of -10 percentage points. Confirmed virologic failure (two consecutive viral loads of ≥200 copies per milliliter) was a key secondary end point.</p><p><strong>Results: </strong>A total of 540 participants were enrolled across seven sites in Kenya, South Africa, and Uganda; 537 were included in the primary analysis. At 48 weeks, 244 of 268 participants (91.0%) in the long-acting-therapy group had a viral load of less than 50 copies per milliliter, as compared with 240 of 269 participants (89.2%) in the oral-therapy group (risk difference, 1.9 percentage points; 95% confidence interval [CI], -3.1 to 6.9), which met the criterion for noninferiority. The results of a per-protocol analysis were consistent with those of the primary analysis. Confirmed virologic failure occurred in 5 participants (1.9%) in the long-acting-therapy group and in no participants in the oral-therapy group (risk difference, 1.9 percentage points; 95% CI, 0.3 to 3.5). Serious adverse events were reported in 11 of 271 participants (4.1%) who received long-acting therapy and in 8 of 269 participants (3.0%) who received oral therapy (risk difference, 1.1 percentage points; 95% CI, -1.1 to 4.2).</p><p><strong>Conclusions: </strong>Among persons with HIV in Africa who have adherence challenges, long-acting cabotegravir plus rilpivirine was noninferior to oral dolutegravir-based therapy for maintaining a viral load of less than 50 copies per milliliter. (Funded by Johnson & Johnson; IMPALA ClinicalTrials.gov number, NCT05546242; Pan African Clinical Trials Registry number, PACT202301600757432TMC278LAHTX3005.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"395 15","pages":"1505-1518"},"PeriodicalIF":84.5,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186288","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}
引用次数: 0
IARC Perspective on Lung Cancer Screening. IARC对肺癌筛查的看法。
IF 84.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-15 Epub Date: 2026-09-24 DOI: 10.1056/NEJMsb2608211
Luciana Neamtiu, Matthew E J Callister, Philip Crosbie, Stephen Lam, Vivienne Milch, Daniela Mariosa, Xiaoshuang Feng, Roya Dolatkhah, Ali Saeed Al-Zahrani, Zhandos Amankulov, Jean-Luc Bulliard, Wendy A Cooper, Luis Corrales, Paolo Giorgi Rossi, Rayjean J Hung, Ella Kazerooni, Mengmeng Li, Peter Mazzone, Rafael Meza, Arn Migowski, Rachael L Murray, Samantha L Quaife, Robert C Rintoul, Witold Rzyman, Wei Jie Seow, Abhishek Shankar, Mahdi Sheikh, Hilary A Robbins, Mattias Johansson, Harry J de Koning, Béatrice Lauby-Secretan
{"title":"IARC Perspective on Lung Cancer Screening.","authors":"Luciana Neamtiu, Matthew E J Callister, Philip Crosbie, Stephen Lam, Vivienne Milch, Daniela Mariosa, Xiaoshuang Feng, Roya Dolatkhah, Ali Saeed Al-Zahrani, Zhandos Amankulov, Jean-Luc Bulliard, Wendy A Cooper, Luis Corrales, Paolo Giorgi Rossi, Rayjean J Hung, Ella Kazerooni, Mengmeng Li, Peter Mazzone, Rafael Meza, Arn Migowski, Rachael L Murray, Samantha L Quaife, Robert C Rintoul, Witold Rzyman, Wei Jie Seow, Abhishek Shankar, Mahdi Sheikh, Hilary A Robbins, Mattias Johansson, Harry J de Koning, Béatrice Lauby-Secretan","doi":"10.1056/NEJMsb2608211","DOIUrl":"10.1056/NEJMsb2608211","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"1545-1552"},"PeriodicalIF":84.5,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149041591","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}
引用次数: 0
Extended DAPT for Multivessel Coronary Artery Disease. 扩展DAPT治疗多支冠状动脉疾病。
IF 84.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-15 DOI: 10.1056/NEJMc2610855
Sukrit Narula, Michael G Nanna
{"title":"Extended DAPT for Multivessel Coronary Artery Disease.","authors":"Sukrit Narula, Michael G Nanna","doi":"10.1056/NEJMc2610855","DOIUrl":"https://doi.org/10.1056/NEJMc2610855","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"395 15","pages":"1560-1561"},"PeriodicalIF":84.5,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186305","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}
引用次数: 0
Alkaptonuria. 尿黑酸尿。
IF 84.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-15 DOI: 10.1056/NEJMicm2607077
Prasanta Padhan, Pratima Singh
{"title":"Alkaptonuria.","authors":"Prasanta Padhan, Pratima Singh","doi":"10.1056/NEJMicm2607077","DOIUrl":"https://doi.org/10.1056/NEJMicm2607077","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"395 15","pages":"1529"},"PeriodicalIF":84.5,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186307","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}
引用次数: 0
Adult Attention Deficit-Hyperactivity Disorder. 成人注意缺陷多动障碍。
IF 84.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-15 DOI: 10.1056/NEJMcp2516040
Jan K Buitelaar, Jeffrey H Newcorn
{"title":"Adult Attention Deficit-Hyperactivity Disorder.","authors":"Jan K Buitelaar, Jeffrey H Newcorn","doi":"10.1056/NEJMcp2516040","DOIUrl":"https://doi.org/10.1056/NEJMcp2516040","url":null,"abstract":"<p><p>Attention deficit-hyperactivity disorder (ADHD) is a medical condition that is present in approximately 2.5% of adults worldwide and manifests in a variety of different ways across the lifespan. Adults with ADHD often have coexisting psychiatric disorders such as anxiety, mood, sleep, substance use, and personality disorders and are at increased risk for coexisting somatic conditions such as obesity, cardiovascular and cerebrovascular disease, type 1 and type 2 diabetes, and immune and inflammatory conditions. Hence, such adults may be seen by clinicians providing care for a wide range of psychiatric and somatic conditions. Nevertheless, ADHD remains unrecognized and undiagnosed in many persons. Assessment requires interviewing of the patient for core ADHD symptoms, coexisting conditions, and their functional effects, which can be facilitated by using standardized rating scales. Key components of treatment are psychoeducation and psychostimulant or nonstimulant medication, mostly in combination with psychosocial interventions and lifestyle guidance.</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"395 15","pages":"1519-1528"},"PeriodicalIF":84.5,"publicationDate":"2026-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186270","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}
引用次数: 0
Health-Related Social Needs among Older Adults — Addressing Mismeasurement 老年人健康相关的社会需求——解决测量错误
IF 158.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-10 DOI: 10.1056/nejmp2608580
Mark A. Unruh,Joshua R. Vest
{"title":"Health-Related Social Needs among Older Adults — Addressing Mismeasurement","authors":"Mark A. Unruh,Joshua R. Vest","doi":"10.1056/nejmp2608580","DOIUrl":"https://doi.org/10.1056/nejmp2608580","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"32 1 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149150406","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}
引用次数: 0
Who Counts as Infertile? A Missed Opportunity for Inclusion 谁算不孕?错失了融入的机会
IF 158.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-10 DOI: 10.1056/nejmp2603604
Paula Amato,I. Glenn Cohen
{"title":"Who Counts as Infertile? A Missed Opportunity for Inclusion","authors":"Paula Amato,I. Glenn Cohen","doi":"10.1056/nejmp2603604","DOIUrl":"https://doi.org/10.1056/nejmp2603604","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"6 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149150400","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}
引用次数: 0
Not Available in Your Country 在你的国家不可用
IF 158.5 1区 医学
New England Journal of Medicine Pub Date : 2026-10-10 DOI: 10.1056/nejmp2609409
Christos P. Kotanidis
{"title":"Not Available in Your Country","authors":"Christos P. Kotanidis","doi":"10.1056/nejmp2609409","DOIUrl":"https://doi.org/10.1056/nejmp2609409","url":null,"abstract":"","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":"269 1","pages":""},"PeriodicalIF":158.5,"publicationDate":"2026-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149150405","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}
引用次数: 0
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