Lancet Gastroenterology & Hepatology最新文献

{"title":"Tulisokibart shows promise for Crohn's disease","authors":"James Lindsay","doi":"10.1016/s2468-1253(25)00103-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00103-7","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"25 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183751","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":"Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial","authors":"Brian G Feagan, Bruce E Sands, Corey A Siegel, Marla C Dubinsky, Randy S Longman, João Sabino, Olivier Laurent, Allison Luo, Jiandong Lu, Deanna D Nguyen, Ernesto J Muñoz-Elias, Heather Llewellyn, Yong Wang, InSock Jang, Janine Bilsborough, Ron Marchelletta, Fadi Towfic, Mark Yen, Jaclyn K Anderson, Aaron DuVall, Dermot P B McGovern","doi":"10.1016/s2468-1253(25)00071-8","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00071-8","url":null,"abstract":"<h3>Background</h3>TNF-like cytokine 1A (TL1A) is a key mediator of inflammation and fibrosis. The efficacy and safety of the anti-TL1A monoclonal antibody tulisokibart as induction treatment was assessed in adults with moderately to severely active Crohn's disease with a history of insufficient response, loss of response, or intolerance to conventional or approved biological therapies.<h3>Methods</h3>In the phase 2a, multicentre, open-label APOLLO-CD study, participants aged 18 years or older with moderately to severely active Crohn's disease, as defined by a Crohn's Disease Activity Index (CDAI) of 220–450 and a Simple Endoscopy Score for Crohn's Disease (SES-CD) of at least 6 for ileocolonic or colonic disease or at least 4 for isolated ileal disease, received intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10). This Article reports the results of the primary analysis of the induction period. The primary endpoints were safety and the proportion of participants with endoscopic response at week 12, defined as a decrease in SES-CD of at least 50% from baseline. Safety was analysed in all participants treated with tulisokibart, and endoscopic response was analysed in the per-protocol analysis set, which included all participants treated with tulisokibart with baseline CDAI and SES-CD scores, except those with prespecified important protocol deviations. This trial is 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>NCT05013905</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 is closed for recruitment; an open-label extension is ongoing.<h3>Findings</h3>Of 101 participants screened for eligibility, 55 eligible participants were enrolled and received tulisokibart. The mean age of participants was 39·1 years (SD 15·7), 34 (62%) were male, 21 (38%) were female, and 39 (71%) had received previous biological therapy. At week 12, endoscopic response was observed in 13 (26·0% [95% CI 15·9–39·6]) of 50 participants receiving tulisokibart in the per-protocol analysis set. Adverse events occurred in 43 (78%) of 55 participants, with most adverse events being mild to moderate in severity. The most frequently occurring adverse events (≥5% of participants) were COVID-19 (six [11%] participants), urinary tract infection (five [9%]), Crohn's disease (five [9%]), anaemia (four [7%]), nasopharyngitis (three [5%]), and fatigue (three [5%]). Eight (15%) participants had serious adverse events, none of which were considered related to the study drug by the investigator. There were no deaths.<h3>Interpretation</h3>This proof-of-concept study showed that tulisoki","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"58 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183933","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":"Standardising HBV nomenclature: a call to action from the HBV Forum","authors":"Su Wang, Mitchell Leus, Markus Cornberg, Marc Ghany, Carey Hwang, Seng Gee Lim, Brian McMahon, C Wendy Spearman, Veronica Miller","doi":"10.1016/s2468-1253(25)00158-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00158-x","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"16 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144176994","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":"Toripalimab plus bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma (HEPATORCH): a randomised, open-label, phase 3 trial","authors":"Yinghong Shi, Guohong Han, Jian Zhou, Xuetao Shi, Weidong Jia, Ying Cheng, Yongdong Jin, Xiangdong Hua, Tianfu Wen, Jianbing Wu, Shanzhi Gu, Yuxian Bai, Xiangcai Wang, Tao Zhang, Zhiyu Chen, Bixiang Zhang, Ming Huang, Hongming Liu, Yilei Mao, Ledu Zhou, Jia Fan","doi":"10.1016/s2468-1253(25)00059-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00059-7","url":null,"abstract":"<h3>Background</h3>Although several PD-1 or PD-L1 inhibitors combined with antiangiogenic agents have been approved as first-line treatment of advanced hepatocellular carcinoma, treatment needs remain unmet given the high incidence and mortality of hepatocellular carcinoma and due to factors such as regional approval status, medical insurance restrictions, and cost considerations. In this phase 3 HEPATORCH study, we aimed to compare the efficacy and safety of toripalimab plus bevacizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma.<h3>Methods</h3>We did a randomised, open-label, phase 3 study in 57 hospitals across mainland China, Taiwan, and Singapore. Using a central interactive web response system, eligible patients aged 18–75 years with unresectable or metastatic hepatocellular carcinoma were randomly assigned (1:1) through a stratified block randomisation method to receive 240 mg toripalimab (intravenously, once every 3 weeks) plus 15 mg/kg bevacizumab (intravenously, once every 3 weeks) or 400 mg sorafenib (oral, twice daily). Randomisation was stratified by macrovascular invasion or extrahepatic spread (presence <em>vs</em> absence), ECOG performance status score (0 <em>vs</em> 1), and history of locoregional therapy (yes <em>vs</em> no). The co-primary endpoints were progression-free survival (assessed by the Independent Review Committee per Response Evaluation Criteria in Solid Tumors, version 1.1) and overall survival. Efficacy analysis was performed in the intention-to-treat population (ie, all patients randomly assigned to a treatment group). Safety was assessed in all patients who received at least one dose of study treatment. The study is 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>NCT04723004</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 is completed.<h3>Findings</h3>Between Nov 23, 2020, and Jan 21, 2022, 545 patients were screened for study inclusion, of whom 219 did not meet the screening criteria. 326 patients were randomly assigned to receive an intervention: 162 patients were assigned to the toripalimab plus bevacizumab group and 164 were assigned to the sorafenib group, with median age 58·0 years (IQR 50·0–66·0) and 56·0 years (49·0–61·0) years, respectively. All 326 patients were included in the intention-to-treat population and the safety population. 282 (87%) patients were male and 44 (14%) were female. At the primary analysis of progression-free survival (data cutoff Aug 10, 2022), median follow-up was 9·4 months (IQR 7·0–12·0). Toripalimab plus bevacizumab significantly prolonged prog","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"235 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144103936","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":"A 2024 global report on national policy, programmes, and progress towards hepatitis B elimination: findings from 33 hepatitis elimination profiles","authors":"Lindsey Hiebert-Suwondo, Jana Manning, Rania A Tohme, Maria Buti, Loreta A Kondili, C Wendy Spearman, Nishi Prabdial-Sing, Victoria Turnier, Jeffrey V Lazarus, Imam Waked, John W Ward","doi":"10.1016/s2468-1253(25)00069-x","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00069-x","url":null,"abstract":"The Coaltion for Global Hepatitis Elimination's National Hepatitis Elimination Profiles assess the status of national data, policy, and programme development the elimination of viral hepatitis. Profiles from 33 countries and territories show progress, towards elimination of hepatitis B with 24 (73%) of them meeting the 2025 WHO interim target of 0·5% or less HBsAg prevalence in children younger than 5 years. 22 (67%) of countries and territories profiled have policies for universal hepatitis B birth-dose vaccination of newborns. Access to hepatitis B testing and treatment, including removing HBsAg screening and hepatitis B treatment patient co-payments and simplifying treatment algorithms, remains suboptimal, especially in low-income and middle-income countries and territories. Of the seven profiled countries and territories meeting the 60% WHO 2025 diagnosis coverage target, all but one (Rwanda) is a high-income country or territory. No country or territory has met the WHO 2025 treatment target of at least 50% of people living with hepatitis B receiving treatment. The profiles guide national planning and identify priorities for resource mobilisation to further accelerate hepatitis B elimination.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"40 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144103935","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":"A 2024 global report on national policies, programmes, and progress towards hepatitis C elimination: findings from 33 hepatitis elimination profiles","authors":"Lindsey Hiebert-Suwondo, Jana Manning, Rania A Tohme, Maria Buti, Loreta A Kondili, C Wendy Spearman, Behzad Hajarizadeh, Victoria Turnier, Jeffrey V Lazarus, Jason Grebely, Gregory J Dore, Imam Waked, John W Ward","doi":"10.1016/s2468-1253(25)00068-8","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00068-8","url":null,"abstract":"The Coalition for Global Hepatitis Elimination's National Hepatitis Elimination Profiles assess the status of national data, policy, and programme development for the elimination of viral hepatitis. To date, profiles from 33 countries and territories have been developed. These profiles reveal that 30 (91%) countries and territories have hepatitis C national action plans, 11 (33%) have systems to monitor hepatitis C-related mortality, 16 (48%) have systems to monitor hepatitis C incidence, and 18 (55%) have systems to track the number of people tested and treated. Some countries and territories continue to uphold barriers to hepatitis C treatment, with 12 (36%) still having partial or full restrictions on prescribing authority for non-specialists. Ten (30%) countries and territories have met the WHO 2025 diagnosis coverage target of 60%, five (15%) have met the treatment target of 50%, and seven (21%) have met the needle and syringe exchange target. Although there are examples of countries and territories across the income spectrum meeting these targets, policy development in low-income and middle-income countries and territories generally lags behind that in high-income countries and territories.","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"309 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144104211","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":"A plasma-based multimetabolite biomarker for early detection of pancreatic cancer","authors":"Julie Earl","doi":"10.1016/s2468-1253(25)00089-5","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00089-5","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"35 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067303","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":"Validation of two plasma multimetabolite signatures for patients at risk of or with suspected pancreatic ductal adenocarcinoma (METAPAC): a prospective, multicentre, investigator-masked, enrichment design, phase 4 diagnostic study","authors":"Ujjwal M Mahajan, Bettina Oehrle, Elisabetta Goni, Oliver Strobel, Jörg Kaiser, Robert Grützmann, Jens Werner, Helmut Friess, Thomas M Gress, Thomas W Seufferlein, Waldemar Uhl, Uwe Will, John P Neoptolemos, Uwe A Wittel, Marlies Vornhülz, Simon Sirtl, Georg Beyer, Ivonne Regel, Stefan Boeck, Volker Heinemann, Jochen Wedemeyer","doi":"10.1016/s2468-1253(25)00056-1","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00056-1","url":null,"abstract":"<h3>Background</h3>Earlier diagnosis of pancreatic ductal adenocarcinoma is key to improving overall survival in patients with this hard-to-treat cancer. We independently validated two previously identified plasma-based metabolic signatures for exclusion of pancreatic ductal adenocarcinoma in cohorts with an increased annual risk.<h3>Methods</h3>The METAPAC study was a prospective, multicentre, investigator-masked, enrichment design, phase 4 trial done in 23 centres in Germany. Patients with pancreatic lesions identified by diagnostic imaging that required further diagnostic assessment were recruited and followed up for 24 months. Targeted quantitative plasma metabolite analysis was done on a liquid chromatography–tandem mass spectrometry platform. The improved metabolic (i-Metabolic) signature consisted of 12 analytes plus carbohydrate antigen (CA) 19-9, and the minimalistic metabolic (m-Metabolic) signature consisted of four analytes plus CA 19-9. The primary endpoint of the study was the exclusion of pancreatic ductal adenocarcinoma with an 85% specificity and the highest possible diagnostic accuracy. All statistical analyses were done per protocol. This study is registered with the German Clinical Trials Register (DRKS00010866).<h3>Findings</h3>Between Sept 9, 2016, and April 8, 2022, 1370 patients with CT-identified pancreatic lesions necessitating further diagnostic assessment were screened, of whom 1129 patients (489 with pancreatic ductal adenocarcinoma, 640 controls) were included in the primary analysis (median age 67 years [IQR 58–75]; 556 [49%] female, 572 [51%] male). The control group consisted of high-risk individuals with acute pancreatitis (11 [1%] of 1129 participants), chronic pancreatitis (113 [10%]), intraductal papillary mucinous neoplasms (232 [21%]), cystic lesions other than intraductal papillary mucinous neoplasms (271 [24%]), and metastases of extrapancreatic origin (13 [1%]). The i-Metabolic signature detected pancreatic ductal adenocarcinoma with an area under the curve (AUC) of 0·846 (95% CI 0·842–0·849), specificity of 90·4% (89·8–91·1), sensitivity of 67·5% (66·9–68·0), and balanced accuracy of 80·5% (80·2–80·8), compared with CA 19-9 alone (AUC 0·799 [0·797–0·802], p<0·0001; specificity 79·1% [78·7–79·4]; sensitivity 81·8% [81·5–82·0]; balanced accuracy 80·6% [80·4–80·9]). The m-Metabolic signature detected pancreatic ductal adenocarcinoma with an AUC of 0·846 (95% CI 0·842–0·849; p<0·0001 <em>vs</em> CA 19-9 alone), specificity of 93·6% (93·1–94·0), sensitivity of 59·9% (59·3–60·4), and accuracy of 79·0% (78·8–79·2). In a population of 242 individuals with new-onset diabetes (three cases of incident pancreatic ductal adenocarcinoma), the m-Metabolic signature (without CA 19-9) significantly discriminated patients with pancreatic ductal adenocarcinoma from those without (p=0·038). AUC, specificity, and sensitivity remained constant after random bootstrapping for a prevalence of pancreatic ductal adenocarcino","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"11 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144067302","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":"Etrasimod in the treatment of eosinophilic oesophagitis: a promising match?","authors":"Ulrike von Arnim","doi":"10.1016/s2468-1253(25)00125-6","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00125-6","url":null,"abstract":"No Abstract","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"76 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143979774","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":"Etrasimod as a treatment for eosinophilic oesophagitis (VOYAGE): a double-blind, placebo-controlled, randomised, phase 2 trial","authors":"Evan S Dellon, Margaret H Collins, Albert J Bredenoord, Hamish Philpott, Luc Biedermann, Márjori Dulcine, Thai Nguyen-Cleary, Chinyu Su, Jin Yu, Huaming Tan, Fabio Cataldi, Joseph Wu, Wenjin Wang, Pamela Clax, John C Woolcott, Ikuo Hirano","doi":"10.1016/s2468-1253(25)00062-7","DOIUrl":"https://doi.org/10.1016/s2468-1253(25)00062-7","url":null,"abstract":"<h3>Background</h3>Novel treatments are needed for eosinophilic oesophagitis. Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)<sub>1,4,5</sub> receptor modulator in development for the treatment of immune-mediated inflammatory diseases. We assessed efficacy and safety of etrasimod versus placebo in adults with eosinophilic oesophagitis.<h3>Methods</h3>In this double-blind, randomised, phase 2 trial, patients aged 18–65 years with a previous diagnosis of eosinophilic oesophagitis and histologically active disease from 64 clinical sites (in Australia, Belgium, Spain, Switzerland, and the USA) were randomly assigned (3:3:2) using an interactive web response system to receive oral etrasimod 2 mg or 1 mg or matching placebo for 24 weeks (centrally randomly assigned and double-blind; placebo-controlled period); they continued assigned etrasimod doses or were randomly assigned (1:1) from placebo to etrasimod 2 mg or 1 mg for 28 weeks (extension period). Randomisation was stratified by history of oesophageal dilation and concurrent proton pump inhibitor therapy. The full analysis set and safety set consisted of all randomly assigned patients who received at least one study treatment dose. The primary endpoint was percentage change from baseline in oesophageal peak eosinophil count (PEC) at week 16. Safety was assessed up to week 52. Patients were analysed according to treatment received in the placebo-controlled period and extension period. The trial 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>NCT04682639</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, 2020-003226-23; completed on June 30, 2023.<h3>Findings</h3>Between Dec 15, 2020, and May 27, 2022, 41 patients were randomly assigned to etrasimod 2 mg (20 [49%] females and 21 [51%] males), 39 to etrasimod 1 mg (17 [44%] females and 22 [56%] males), and 28 to placebo (14 [50%] females and 14 [50%] males). 85 (79%) of 108 patients completed the double-blind period, entering the extension period. Median percentage changes from baseline in PEC at week 16 were −58·4% (IQR −86·2 to −26·3) for etrasimod 2 mg (p=0·010 <em>vs</em> placebo), −39·4% (−71·1 to 79·0) for etrasimod 1 mg (p=0·29 <em>vs</em> placebo) and −21·5% (−57·2 to 55·4) for placebo. In the placebo-controlled period, the most common treatment-emergent adverse events were gastrointestinal disorders (11 [27%] of 41 patients in the etrasimod 2 mg group, 13 [33%] of 39 patients in the etrasimod 1 mg group, and 14 [50%] of 28 patients in the placebo group). Bradycardia events, reported by three patients (two [5%] patients in","PeriodicalId":56028,"journal":{"name":"Lancet Gastroenterology & Hepatology","volume":"55 1","pages":""},"PeriodicalIF":35.7,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143980082","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}