Pub Date : 2025-01-10DOI: 10.1016/s2468-1253(24)00404-7
Ziwei Gao, Wei Ye, Jingru Song
No Abstract
没有抽象的
{"title":"Denifanstat for the treatment of metabolic dysfunction-associated steatohepatitis","authors":"Ziwei Gao, Wei Ye, Jingru Song","doi":"10.1016/s2468-1253(24)00404-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00404-7","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"26 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142961887","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 : 2025-01-10DOI: 10.1016/s2468-1253(24)00440-0
Holly Baker
<h2>Section snippets</h2><section><section><h2>Guselkumab for moderately to severely active ulcerative colitis</h2>Guselkumab is a safe and efficacious treatment option for patients with moderately to severely active ulcerative colitis, according to the <span><span>phase 3 QUASAR induction and maintenance studies</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>. David T Rubin and colleagues randomly assigned patients with inadequate response or intolerance to conventional or advanced ulcerative colitis therapy to receive guselkumab 200 mg intravenously (n=421) or placebo (n=280) at weeks 0, 4, and 8 (induction study). At 12 weeks, 95 (23%) of 421 patients in the</section></section><section><section><h2>Nivolumab plus ipilimumab for MSI-H colorectal cancer</h2>Nivolumab plus ipilimumab increases survival in patients with microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) metastatic colorectal cancer, according to the phase 3 <span><span>CheckMate 8HW trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>. Thierry Andre and colleagues randomly assigned patients with unresectable or metastatic colorectal cancer and MSI-H or dMMR status according to local testing to receive either nivolumab plus ipilimumab, nivolumab alone, or chemotherapy with or without targeted therapies. In this</section></section><section><section><h2><span><span>Impact of coeliac disease on gut function and microbiome</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span></h2>Coeliac disease has an impact on gut function and microbiome composition that is not reversed by a gluten-free diet, according to new research. Carolyn Costigan and colleagues used MRI and stool sample analysis to examine gut function and microbiome composition of 36 patients with newly diagnosed coeliac disease and an equal number of healthy volunteers. At baseline, patients with coeliac disease had significantly higher small bowel water content and delayed gut transit times compared with</section></section><section><section><h2>Combination therapy for acute severe ulcerative colitis</h2>Combination therapy with infliximab plus azathioprine shows promise in patients with acute severe ulcerative colitis responsive to intravenous steroids, according to the <span><span>phase 4 ACTIVE trial</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>. Aurelien Am
{"title":"Research in Brief","authors":"Holly Baker","doi":"10.1016/s2468-1253(24)00440-0","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00440-0","url":null,"abstract":"<h2>Section snippets</h2><section><section><h2>Guselkumab for moderately to severely active ulcerative colitis</h2>Guselkumab is a safe and efficacious treatment option for patients with moderately to severely active ulcerative colitis, according to the <span><span>phase 3 QUASAR induction and maintenance studies</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>. David T Rubin and colleagues randomly assigned patients with inadequate response or intolerance to conventional or advanced ulcerative colitis therapy to receive guselkumab 200 mg intravenously (n=421) or placebo (n=280) at weeks 0, 4, and 8 (induction study). At 12 weeks, 95 (23%) of 421 patients in the</section></section><section><section><h2>Nivolumab plus ipilimumab for MSI-H colorectal cancer</h2>Nivolumab plus ipilimumab increases survival in patients with microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) metastatic colorectal cancer, according to the phase 3 <span><span>CheckMate 8HW trial</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>. Thierry Andre and colleagues randomly assigned patients with unresectable or metastatic colorectal cancer and MSI-H or dMMR status according to local testing to receive either nivolumab plus ipilimumab, nivolumab alone, or chemotherapy with or without targeted therapies. In this</section></section><section><section><h2><span><span>Impact of coeliac disease on gut function and microbiome</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span></h2>Coeliac disease has an impact on gut function and microbiome composition that is not reversed by a gluten-free diet, according to new research. Carolyn Costigan and colleagues used MRI and stool sample analysis to examine gut function and microbiome composition of 36 patients with newly diagnosed coeliac disease and an equal number of healthy volunteers. At baseline, patients with coeliac disease had significantly higher small bowel water content and delayed gut transit times compared with</section></section><section><section><h2>Combination therapy for acute severe ulcerative colitis</h2>Combination therapy with infliximab plus azathioprine shows promise in patients with acute severe ulcerative colitis responsive to intravenous steroids, according to the <span><span>phase 4 ACTIVE trial</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>. Aurelien Am","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"6 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142961901","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 : 2025-01-10DOI: 10.1016/s2468-1253(24)00441-2
No Abstract
没有抽象的
{"title":"The rise in early-onset colorectal cancer: now a global issue","authors":"","doi":"10.1016/s2468-1253(24)00441-2","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00441-2","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"21 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142961897","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 : 2025-01-10DOI: 10.1016/s2468-1253(24)00283-8
Muhammad Usman, Nasir Javed, Aida Jawhari, Nazim Ghouri, Salman Waqar, Fathima Shah, Saqib Ahmad, Ailsa Hart, Bilal Hameed, Mohammad Qasim Khan, Mohammad Farhad Peerally
Ramadan intermittent fasting can pose challenges and risks for some groups of patients. Based on a narrative literature review and our clinical expertise, we provide practical guidance for clinicians managing patients with gastrointestinal and hepatobiliary conditions who wish to fast during Ramadan. Following the established International Diabetes Federation and Diabetes and Ramadan International Alliance risk stratification framework, we categorised patients’ risk as low or moderate, high, or very high. We advise all patients at very high risk and most patients at high risk to not observe fasting due to potential harm. For others, we offer nuanced recommendations on medication rescheduling, lifestyle changes, and tailored fasting advice to minimise adverse effects. Shared decision making that respects patients’ religious motivations is essential, with risks and benefits carefully weighed on an individual basis.
{"title":"Ramadan intermittent fasting for patients with gastrointestinal and hepatobiliary diseases: practical guidance for health-care professionals","authors":"Muhammad Usman, Nasir Javed, Aida Jawhari, Nazim Ghouri, Salman Waqar, Fathima Shah, Saqib Ahmad, Ailsa Hart, Bilal Hameed, Mohammad Qasim Khan, Mohammad Farhad Peerally","doi":"10.1016/s2468-1253(24)00283-8","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00283-8","url":null,"abstract":"Ramadan intermittent fasting can pose challenges and risks for some groups of patients. Based on a narrative literature review and our clinical expertise, we provide practical guidance for clinicians managing patients with gastrointestinal and hepatobiliary conditions who wish to fast during Ramadan. Following the established International Diabetes Federation and Diabetes and Ramadan International Alliance risk stratification framework, we categorised patients’ risk as low or moderate, high, or very high. We advise all patients at very high risk and most patients at high risk to not observe fasting due to potential harm. For others, we offer nuanced recommendations on medication rescheduling, lifestyle changes, and tailored fasting advice to minimise adverse effects. Shared decision making that respects patients’ religious motivations is essential, with risks and benefits carefully weighed on an individual basis.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"84 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142961902","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 : 2025-01-09DOI: 10.1016/s2468-1253(24)00428-x
Christopher J Black, Alexander C Ford
No Abstract
没有抽象的
{"title":"The case for reducing the use of diagnostic upper and lower gastrointestinal endoscopy","authors":"Christopher J Black, Alexander C Ford","doi":"10.1016/s2468-1253(24)00428-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00428-x","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"35 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142936879","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 : 2025-01-07DOI: 10.1016/s2468-1253(24)00386-8
Bruce E Sands, Remo Panaccione, Geert D'Haens, Stefan Schreiber, Vipul Jairath, Aaron DuVall, Jaroslaw Kierkus, Michael Walczak, Snehal Naik, Kye Gilder, Beatriz Lindstrom, Kathleen Ogilvie, William J Sandborn, Severine Vermeire, David T Rubin, Laurent Peyrin-Biroulet, Silvio Danese
<h3>Background</h3>Tamuzimod (VTX002) is a selective sphingosine 1-phosphate receptor 1 modulator in development for ulcerative colitis. We aimed to assess the safety and efficacy of tamuzimod in patients with moderately-to-severely active ulcerative colitis.<h3>Methods</h3>This double-blind, randomised, placebo-controlled, phase 2 induction trial was conducted at 122 centres across 15 countries in Asia, Europe, and North America. Patients aged 18–80 years with a modified Mayo score (MMS) of 4–9 and an inadequate response or a loss of response, or intolerance to one or more approved ulcerative colitis therapies were randomly assigned (1:1:1) to once-daily oral tamuzimod (60 mg or 30 mg) or placebo for 13 weeks. Randomisation was stratified by previous advanced therapy, baseline corticosteroid, and baseline MMS. The primary endpoint was clinical remission (defined as an MMS stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore ≤1, excluding friability) at week 13. Adverse events and laboratory abnormalities were assessed for safety. Efficacy and safety analyses included all randomly assigned patients who received at least one study dose, with the efficacy analysis restricted to patients with a baseline MMS of 5–9 based on regulatory feedback. The study was registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, <span><span>NCT05156125</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, and EudraCT, 2021-003050-23.<h3>Findings</h3>Between Nov 4, 2021, and Aug 30, 2023, 367 patients were screened, and 213 (mean age 40·6 years [SD 14·2]; 116 [54%] males and 97 [46%] females) were randomly assigned to tamuzimod 60 mg (n=70), tamuzimod 30 mg (n=73), or placebo (n=70). Two in the tamuzimod 30 mg group and two in the tamuzimod 60 mg group with baseline modified Mayo score of 4 were excluded from the efficacy analysis. At week 13, clinical remission was reached by 19 (28%) of 68 patients receiving tamuzimod 60 mg, 17 (24%) of 71 patients receiving tamuzimod 30 mg, and eight (11%) of 70 patients receiving placebo (risk difference 16·5% [95% CI 3·2 to 29·4], p=0·018, for tamuzimod 60 mg <em>vs</em> placebo and 12·5% [–0·2 to 24·9], p=0·041, for tamuzimod 30 mg <em>vs</em> placebo). Treatment-emergent adverse events occurred in 33 (47%) of 70 patients receiving tamuzimod 60 mg, 34 (47%) of 73 patients receiving tamuzimod 30 mg, and 24 (34%) of 70 patients receiving placebo. Most adverse events were mild or moderate. The most frequently reported treatment-emergent adverse events (in ≥5% of in any treatment group) were upper respiratory tract infection (six [9%] of 70 p
{"title":"Tamuzimod in patients with moderately-to-severely active ulcerative colitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 induction trial","authors":"Bruce E Sands, Remo Panaccione, Geert D'Haens, Stefan Schreiber, Vipul Jairath, Aaron DuVall, Jaroslaw Kierkus, Michael Walczak, Snehal Naik, Kye Gilder, Beatriz Lindstrom, Kathleen Ogilvie, William J Sandborn, Severine Vermeire, David T Rubin, Laurent Peyrin-Biroulet, Silvio Danese","doi":"10.1016/s2468-1253(24)00386-8","DOIUrl":"https://doi.org/10.1016/s2468-1253(24)00386-8","url":null,"abstract":"<h3>Background</h3>Tamuzimod (VTX002) is a selective sphingosine 1-phosphate receptor 1 modulator in development for ulcerative colitis. We aimed to assess the safety and efficacy of tamuzimod in patients with moderately-to-severely active ulcerative colitis.<h3>Methods</h3>This double-blind, randomised, placebo-controlled, phase 2 induction trial was conducted at 122 centres across 15 countries in Asia, Europe, and North America. Patients aged 18–80 years with a modified Mayo score (MMS) of 4–9 and an inadequate response or a loss of response, or intolerance to one or more approved ulcerative colitis therapies were randomly assigned (1:1:1) to once-daily oral tamuzimod (60 mg or 30 mg) or placebo for 13 weeks. Randomisation was stratified by previous advanced therapy, baseline corticosteroid, and baseline MMS. The primary endpoint was clinical remission (defined as an MMS stool frequency subscore of ≤1, rectal bleeding subscore of 0, and endoscopic subscore ≤1, excluding friability) at week 13. Adverse events and laboratory abnormalities were assessed for safety. Efficacy and safety analyses included all randomly assigned patients who received at least one study dose, with the efficacy analysis restricted to patients with a baseline MMS of 5–9 based on regulatory feedback. The study was registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT05156125</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, and EudraCT, 2021-003050-23.<h3>Findings</h3>Between Nov 4, 2021, and Aug 30, 2023, 367 patients were screened, and 213 (mean age 40·6 years [SD 14·2]; 116 [54%] males and 97 [46%] females) were randomly assigned to tamuzimod 60 mg (n=70), tamuzimod 30 mg (n=73), or placebo (n=70). Two in the tamuzimod 30 mg group and two in the tamuzimod 60 mg group with baseline modified Mayo score of 4 were excluded from the efficacy analysis. At week 13, clinical remission was reached by 19 (28%) of 68 patients receiving tamuzimod 60 mg, 17 (24%) of 71 patients receiving tamuzimod 30 mg, and eight (11%) of 70 patients receiving placebo (risk difference 16·5% [95% CI 3·2 to 29·4], p=0·018, for tamuzimod 60 mg <em>vs</em> placebo and 12·5% [–0·2 to 24·9], p=0·041, for tamuzimod 30 mg <em>vs</em> placebo). Treatment-emergent adverse events occurred in 33 (47%) of 70 patients receiving tamuzimod 60 mg, 34 (47%) of 73 patients receiving tamuzimod 30 mg, and 24 (34%) of 70 patients receiving placebo. Most adverse events were mild or moderate. The most frequently reported treatment-emergent adverse events (in ≥5% of in any treatment group) were upper respiratory tract infection (six [9%] of 70 p","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"99 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142936331","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}