Therapeutic Advances in Gastroenterology最新文献

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Bowel preparation efficacy and discomfort of 2 L polyethylene glycol combined with linaclotide versus 3 L polyethylene glycol: a noninferiority, prospective, multicenter, randomized controlled trial. 2 升聚乙二醇联合利那洛肽与 3 升聚乙二醇的肠道准备疗效和不适感对比:一项非劣效性、前瞻性、多中心、随机对照试验。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-11-19 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241299739
Jiandi Wu, Song Liu, Shuyu Li, Gangping Li, Erchuan Wang, Tao Bai, Xiaohua Hou, Jun Song
{"title":"Bowel preparation efficacy and discomfort of 2 L polyethylene glycol combined with linaclotide versus 3 L polyethylene glycol: a noninferiority, prospective, multicenter, randomized controlled trial.","authors":"Jiandi Wu, Song Liu, Shuyu Li, Gangping Li, Erchuan Wang, Tao Bai, Xiaohua Hou, Jun Song","doi":"10.1177/17562848241299739","DOIUrl":"10.1177/17562848241299739","url":null,"abstract":"<p><strong>Background: </strong>Three liters of polyethylene glycol administered in a split dose is a commonly recommended regimen for bowel preparation before colonoscopy.</p><p><strong>Objectives: </strong>The aim of this study was to compare the quality and tolerability of low-dose (2 L) polyethylene glycol combined with linaclotide (2 L+L) versus the 3 L polyethylene glycol (PEG) bowel preparation regimen.</p><p><strong>Design: </strong>A noninferiority, prospective, multicenter, randomized controlled trial.</p><p><strong>Methods: </strong>In this noninferiority, prospective, multicenter, randomized controlled study, patients scheduled for colonoscopy were enrolled and randomized to receive a 3 L PEG or 2L PEG+L regimen. The quality of bowel preparation and patients' discomfort was assessed.</p><p><strong>Results: </strong>Over 12 months, 458 patients were randomized into 3 L PEG and 2 L+L groups. The primary endpoints showed that the 2 L+L regimen was superior to the 3L PEG regimen in overall bowel cleansing scores (Ottawa Bowel Preparation Scale: 3.3 ± 2.1 vs 3.7 ± 2.1, <i>p</i> = 0.021), but no significant difference in adequate bowel preparation rate between the two groups according to the OBPS score (97% vs 97.4%, <i>p</i> = 0.791). Before colonoscopy, patients in the 2 L +L regimen group had lower bloating scores (0.5 (0, 2) vs 1 (0, 3), <i>p</i> = 0.013), discomfort scores (1 (0, 2) vs 1 (0, 3), <i>p</i> = 0.006), and intolerability scores (1 (0, 3) vs 2 (0, 4), <i>p</i> = 0.016) than did those in the 3L PEG group.</p><p><strong>Conclusion: </strong>Two liters of polyethylene glycol combined with linaclotide may be an alternative regimen to 3 L of PEG taken in split doses for bowel preparation before colonoscopy.</p><p><strong>Trial registration: </strong>ChiCTR2100041992.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241299739"},"PeriodicalIF":3.9,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11577450/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142683149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Short-term effectiveness and safety of ustekinumab and vedolizumab in elderly and non-elderly patients with Crohn's disease: a comparative study. 对老年和非老年克罗恩病患者使用乌司替尼和韦多珠单抗的短期有效性和安全性:一项比较研究。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-11-19 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241299752
Lior Dar, Uria Shani, Arad Dotan, Offir Ukashi, Shomron Ben-Horin, Uri Kopylov, Asaf Levartovsky
{"title":"Short-term effectiveness and safety of ustekinumab and vedolizumab in elderly and non-elderly patients with Crohn's disease: a comparative study.","authors":"Lior Dar, Uria Shani, Arad Dotan, Offir Ukashi, Shomron Ben-Horin, Uri Kopylov, Asaf Levartovsky","doi":"10.1177/17562848241299752","DOIUrl":"10.1177/17562848241299752","url":null,"abstract":"<p><strong>Background: </strong>Inflammatory bowel disease (IBD) presents unique challenges in elderly patients due to comorbidities and treatment-related risks.</p><p><strong>Objectives: </strong>This study evaluates ustekinumab (UST) and vedolizumab (VDZ) efficacy and safety in elderly Crohn's disease (CD) patients.</p><p><strong>Design: </strong>A retrospective cohort study at a tertiary medical center.</p><p><strong>Methods: </strong>CD patients aged ⩾60 years (elderly) treated with UST, compared to non-elderly (<60 years) patients treated with UST and elderly patients treated with VDZ. Clinical response was evaluated using the Harvey-Bradshaw index (HBI) and clinical biomarkers, alongside monitoring steroid use, hospitalization rates, treatment persistence, and surgical interventions.</p><p><strong>Results: </strong>The study included 166 CD patients: 32 elderly and 65 non-elderly patients treated with UST, and 69 elderly patients treated with VDZ. The mean duration of follow-up was 10.8 ± 2.8 months in the non-elderly group, 9.97 ± 3.28 months in the elderly UST group, and 10.0 ± 3.29 months in the VDZ group. Elderly UST patients were more likely to receive corticosteroids at initiation than non-elderly UST patients (44% vs 14%, <i>p</i> = 0.001). At 12 months, clinical response rates did not significantly differ between elderly and non-elderly UST groups, respectively (48% vs 40%, <i>p</i> = 0.5). However, elderly UST patients exhibited higher hospitalization rates over time compared to non-elderly UST patients (6-month: 19% vs 6.2%, <i>p</i> = 0.077; 12-month: 19% vs 4.6%, <i>p</i> = 0.055; log-rank <i>p</i> = 0.004). No significant differences were observed in clinical response and remission rates between elderly UST and elderly VDZ patients at 6 and 12 months. At 6 months, a higher hospitalization rate was observed in the UST group (19% vs 4.3% <i>p</i> = 0.027), but this difference did not persist over time.</p><p><strong>Conclusion: </strong>UST and VDZ are effective and safe treatments for elderly CD patients, despite higher hospitalization rates compared to non-elderly patients, likely due to age-related complications.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241299752"},"PeriodicalIF":3.9,"publicationDate":"2024-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11577457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142683155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Sequential endoscopic treatment for esophageal and gastric variceal bleeding significantly reduces patient mortality and rebleeding rates. 食管和胃静脉曲张出血的序贯内镜治疗可显著降低患者死亡率和再出血率。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-11-14 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241299743
Kong Tao, Xu Shan, Binbo He, Qingyu Zeng, Meirong Wu, Liu Jie, Wenfeng Yuan, Hu Dan, Zhang Tao
{"title":"Sequential endoscopic treatment for esophageal and gastric variceal bleeding significantly reduces patient mortality and rebleeding rates.","authors":"Kong Tao, Xu Shan, Binbo He, Qingyu Zeng, Meirong Wu, Liu Jie, Wenfeng Yuan, Hu Dan, Zhang Tao","doi":"10.1177/17562848241299743","DOIUrl":"10.1177/17562848241299743","url":null,"abstract":"<p><strong>Background: </strong>Esophageal-gastric variceal bleeding (EGVB) is a serious complication in patients with liver cirrhosis, characterized by high mortality and rebleeding rates. The effect of sequential endoscopic therapy on patient mortality and rebleeding rates remains unclear.</p><p><strong>Objectives: </strong>This study aimed to evaluate the effects of sequential endoscopic therapy on mortality and rebleeding rates in patients with EGVB.</p><p><strong>Design: </strong>In this single-center retrospective study, 373 hospitalized cases of EGVB caused by liver cirrhosis, collected between November 2019 and November 2023, were divided into four groups according to different treatment methods: a sequential endoscopy group, emergency endoscopy group, emergency endoscopy plus transjugular intrahepatic portosystemic shunt (TIPS) group and control group.</p><p><strong>Methods: </strong>Mortality and rebleeding rates were compared among the four groups using statistical analyses.</p><p><strong>Results: </strong>The mortality and rebleeding rates of the sequential endoscopy group (3.7% and 19%, respectively) were significantly lower than those of the emergency endoscopy (22% and 36%, respectively), emergency endoscopy plus TIPS (33% and 28%, respectively), and control groups (33% and 51%, respectively) (<i>p</i> = 0.013 and <i>p</i> = 0.013, respectively).</p><p><strong>Conclusion: </strong>Sequential endoscopic therapy may significantly reduce the mortality and rebleeding rates of patients with EGVB compared to other conventional treatment strategies. The findings of the study could help develop approaches benefiting EGVB treatment.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241299743"},"PeriodicalIF":3.9,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11565611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142649388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Modernizing metabolic dysfunction-associated steatotic liver disease diagnostics: the progressive shift from liver biopsy to noninvasive techniques. 代谢功能障碍相关脂肪肝诊断的现代化:从肝活检到无创技术的逐步转变。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-11-14 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241276334
David Hudson, Tamoor Afzaal, Hasan Bualbanat, Raaed AlRamdan, Nisha Howarth, Pavithra Parthasarathy, Alia AlDarwish, Emily Stephenson, Yousef Almahanna, Maytham Hussain, Luis Antonio Diaz, Juan Pablo Arab
{"title":"Modernizing metabolic dysfunction-associated steatotic liver disease diagnostics: the progressive shift from liver biopsy to noninvasive techniques.","authors":"David Hudson, Tamoor Afzaal, Hasan Bualbanat, Raaed AlRamdan, Nisha Howarth, Pavithra Parthasarathy, Alia AlDarwish, Emily Stephenson, Yousef Almahanna, Maytham Hussain, Luis Antonio Diaz, Juan Pablo Arab","doi":"10.1177/17562848241276334","DOIUrl":"10.1177/17562848241276334","url":null,"abstract":"<p><p>Metabolic dysfunction-associated steatotic liver disease (MASLD) is a growing public health concern worldwide. Liver biopsy is the gold standard for diagnosing and staging MASLD, but it is invasive and carries associated risks. In recent years, there has been significant progress in developing noninvasive techniques for evaluation. This review article discusses briefly current available noninvasive assessments and the various liver biopsy techniques available for MASLD, including invasive techniques such as transjugular and transcutaneous needle biopsy, intraoperative/laparoscopic biopsy, and the evolving role of endoscopic ultrasound-guided biopsy. In addition to discussing the various biopsy techniques, we review the current state of knowledge on the histopathologic evaluation of MASLD, including the various scoring systems used to grade and stage the disease. We also explore current and alternative modalities for histopathologic evaluation, such as whole slide imaging and the utility of immunohistochemistry. Overall, this review article provides a comprehensive overview of the progress in liver biopsy techniques for MASLD and compares invasive and noninvasive modalities. However, beyond clinical trials, the practical application of liver biopsy may be limited, as ongoing advancements in noninvasive fibrosis assessments are expected to more effectively identify candidates for MASLD treatment in real-world settings.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241276334"},"PeriodicalIF":3.9,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11565685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142649387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Timing of endoscopy in cirrhotic patients with acute variceal bleeding: protocol of a multicenter randomized controlled trial. 肝硬化急性静脉曲张出血患者的内镜检查时机:多中心随机对照试验方案。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-11-13 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241295452
Xingshun Qi, Yiling Li, Bimin Li, Xuefeng Luo, Xiaofeng Liu, Chunqing Zhang, Mingkai Chen, Derun Kong, Yunhai Wu, Fernando Gomes Romeiro, Metin Basaranoglu, Jianzhong Zhang, Qianqian Li, Ran Wang, Xiaodong Shao, Lin Guan, Ningning Wang, Yu You, Mingyan He, Xiaoze Wang, Ju Huang, Wenming Wu, Qun Li, Mingyan Zhang, Guangchuan Wang, Chi Zhang, Du Cheng, Qianqian Zhang, Xuechan Mei, Na Sun, Yuan Ban, Mariana Barros Marcondes, Fabio da Silva Yamashiro, Emine Mutlu, Zheng Zheng, Mengyuan Peng, Wentao Xu, Zhe Li, Lu Chai, Enqiang Linghu
{"title":"Timing of endoscopy in cirrhotic patients with acute variceal bleeding: protocol of a multicenter randomized controlled trial.","authors":"Xingshun Qi, Yiling Li, Bimin Li, Xuefeng Luo, Xiaofeng Liu, Chunqing Zhang, Mingkai Chen, Derun Kong, Yunhai Wu, Fernando Gomes Romeiro, Metin Basaranoglu, Jianzhong Zhang, Qianqian Li, Ran Wang, Xiaodong Shao, Lin Guan, Ningning Wang, Yu You, Mingyan He, Xiaoze Wang, Ju Huang, Wenming Wu, Qun Li, Mingyan Zhang, Guangchuan Wang, Chi Zhang, Du Cheng, Qianqian Zhang, Xuechan Mei, Na Sun, Yuan Ban, Mariana Barros Marcondes, Fabio da Silva Yamashiro, Emine Mutlu, Zheng Zheng, Mengyuan Peng, Wentao Xu, Zhe Li, Lu Chai, Enqiang Linghu","doi":"10.1177/17562848241295452","DOIUrl":"10.1177/17562848241295452","url":null,"abstract":"<p><strong>Background: </strong>Endoscopy is important for the diagnosis and treatment of acute upper gastrointestinal bleeding (AUGIB), especially acute variceal bleeding (AVB), in liver cirrhosis. However, the optimal timing of endoscopy remains controversial, primarily because the currently available evidence is of poor quality, and the definition of early endoscopy is also very heterogeneous among studies. Herein, a multicenter randomized controlled trial (RCT) is performed to explore the impact of the timing of endoscopy on the outcomes of cirrhotic patients with AVB.</p><p><strong>Methods: </strong>A total of 368 cirrhotic patients presenting with AUGIB who are highly suspected to be from AVB will be enrolled. They will be stratified according to the severity of liver function and clinical presentation at admission and then randomly assigned at a 1:1 ratio into early (within 12 h after admission) and delayed (within 12-24 h after admission) endoscopy groups within each stratum. The primary outcomes include the rates of 5-day failure to control bleeding after admission and 6-week rebleeding. The secondary outcomes include 6-week mortality and incidence of adverse events.</p><p><strong>Conclusion: </strong>Considering existing evidence originates from non-randomized studies, this RCT will provide high-quality evidence to uncover whether cirrhotic patients with AVB should undergo early endoscopy to control bleeding and improve survival.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT06031402.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241295452"},"PeriodicalIF":3.9,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558738/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142630513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Appropriateness of small molecule agents for patients with IBD of childbearing age - a RAND/UCLA appropriateness panel. 育龄 IBD 患者使用小分子药物的适宜性--兰德/加州大学洛杉矶分校适宜性小组。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-11-13 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241299737
Christian Selinger, Robyn Laube, Jimmy K Limdi, Kate Headley, Alexandra Kent, Klaartje Kok, Aileen Fraser, Victoria Newman, Helen Ludlow, Fiona Rees, Nidhi Sagar, Erin Walker
{"title":"Appropriateness of small molecule agents for patients with IBD of childbearing age - a RAND/UCLA appropriateness panel.","authors":"Christian Selinger, Robyn Laube, Jimmy K Limdi, Kate Headley, Alexandra Kent, Klaartje Kok, Aileen Fraser, Victoria Newman, Helen Ludlow, Fiona Rees, Nidhi Sagar, Erin Walker","doi":"10.1177/17562848241299737","DOIUrl":"10.1177/17562848241299737","url":null,"abstract":"<p><strong>Background: </strong>Many women of childbearing age with inflammatory bowel disease (IBD) require advanced therapies. While biologics are largely low risk during pregnancy, the novel small molecules tofacitinib, filgotinib, upadacitinib and ozanimod (TFUO) have shown concerning teratogenic effects, and decreased fertility in animal studies. Therefore, their use in women of childbearing age needs careful consideration.</p><p><strong>Design: </strong>RAND/University of California Los Angeles (UCLA) Appropriateness Method (RAM).</p><p><strong>Objective: </strong>To evaluate the appropriateness of TFUO in women of childbearing age.</p><p><strong>Methods: </strong>We convened a panel of six gastroenterologists, two IBD nurses, one IBD pharmacist and three expert patients. Following a literature review, 13 statements were drafted and voted upon in 2 rounds.</p><p><strong>Results: </strong>All 13 statements were deemed appropriate. The panel concluded that women with IBD of childbearing age who wish to commence therapy with TFUO, need to use effective contraception and be counselled regarding the risk in unplanned pregnancies. For women using contraception while on Janus kinase inhibitor (JAKi) therapy, we suggest the preferred use of progesterone-only or non-hormonal long-acting contraception. TFUO are contraindicated during pregnancy and breast feeding. We recommend that women receiving TFUO cease therapy in time to establish clinical remission for at least 3 months prior to conception. Therapies other than TFUO should be considered as first-line therapy in women with IBD of childbearing age, except in select individual circumstances. TFUO may be appropriate for women of childbearing age after failure of, intolerance or contraindications to one biological agent.</p><p><strong>Conclusion: </strong>TFUO should be avoided during pregnancy and breastfeeding, and alternative therapies should be considered as first-line treatments.</p><p><strong>Summary: </strong>We provide clinical practice recommendations regarding the use of TFUO for IBD in women of childbearing age.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241299737"},"PeriodicalIF":3.9,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142630378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Crohn's disease management: translating STRIDE-II for UK clinical practice. 克罗恩病管理:将 STRIDE-II 转化为英国临床实践。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-11-07 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241280885
Karen Kemp, Mark A Samaan, Ajay M Verma, Alan J Lobo
{"title":"Crohn's disease management: translating STRIDE-II for UK clinical practice.","authors":"Karen Kemp, Mark A Samaan, Ajay M Verma, Alan J Lobo","doi":"10.1177/17562848241280885","DOIUrl":"https://doi.org/10.1177/17562848241280885","url":null,"abstract":"<p><p>Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) characterised by endoscopic inflammation, progressive bowel damage and gastrointestinal lesions. Although treatment strategies for CD have traditionally focused on a stepwise pharmacological approach to achieve clinical remission or symptom resolution, these treatment goals correlate poorly with disease activity. Thus, achieving full clinical remission and full endoscopic healing alone may be insufficient, as patients may remain at risk of inflammatory complications. Individualised 'treat-to-target' (T2T) pharmacological and treatment approaches represent a promising strategy for improving endoscopic remission and symptom resolution among patients with CD. The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) and STRIDE-II guidelines, launched in 2013 and later renewed, identified individualised targets for a T2T therapeutic approach for patients with IBD. These guidelines facilitate the individualisation of target treatment goals through evidence-based, long-term (health-related quality of life, absence of disability, endoscopic healing) and intermediate/short-term (abdominal pain, stool frequency, normalisation of biomarker levels) treatment targets, allowing patients and clinicians to consider the risk-to-benefit balance of goals and selected therapeutic strategies. This article aims to summarise the STRIDE-II guidelines and provide intellectual guidance for healthcare professionals to apply the STRIDE-II principles to current clinical practice in the United Kingdom (UK). Management recommendations for primary and secondary first-line non-responders are provided, along with suggestions for utilising the endoscopic outcomes scoring system in UK clinical practice.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241280885"},"PeriodicalIF":3.9,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11544685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142630393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials. 接受依曲莫德治疗的溃疡性结肠炎患者的非严重不良事件:对 II 期 OASIS 和 III 期 ELEVATE UC 52 和 ELEVATE UC 12 临床试验的分析。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-11-07 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241293643
Charlie W Lees, Joana Torres, Yvette Leung, Séverine Vermeire, Marc Fellmann, Irene Modesto, Aoibhinn McDonnell, Krisztina Lazin, Michael Keating, Martina Goetsch, Joseph Wu, Edward V Loftus
{"title":"Non-serious adverse events in patients with ulcerative colitis receiving etrasimod: an analysis of the phase II OASIS and phase III ELEVATE UC 52 and ELEVATE UC 12 clinical trials.","authors":"Charlie W Lees, Joana Torres, Yvette Leung, Séverine Vermeire, Marc Fellmann, Irene Modesto, Aoibhinn McDonnell, Krisztina Lazin, Michael Keating, Martina Goetsch, Joseph Wu, Edward V Loftus","doi":"10.1177/17562848241293643","DOIUrl":"https://doi.org/10.1177/17562848241293643","url":null,"abstract":"<p><strong>Background: </strong>Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate (S1P)<sub>1,4,5</sub> receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). It is known that non-serious treatment-emergent adverse events (TEAEs) may not lead to UC drug discontinuation but can affect treatment tolerability.</p><p><strong>Objectives: </strong>This post hoc analysis evaluated the incidence of specific, common, non-serious TEAEs reported in the etrasimod UC clinical programme and the characteristics of affected patients.</p><p><strong>Design: </strong>Data included patients from the Placebo-controlled UC cohort (phase II OASIS, and phase III ELEVATE UC 52 and ELEVATE UC 12 trials) receiving QD etrasimod (2 or 1 mg) or placebo.</p><p><strong>Methods: </strong>Proportions and incidence rates (IRs; the number of patients with a TEAE divided by the total exposure in patient-years (PYs), per 100 PY) of Headache, Pyrexia, Nausea and Dizziness TEAEs were reported. Changes in heart rate among patients with Dizziness TEAEs were also evaluated.</p><p><strong>Results: </strong>Among 943 patients (etrasimod 2 mg, <i>N</i> = 577 (276.7 PY); etrasimod 1 mg, <i>N</i> = 52 (11.4 PY); placebo, <i>N</i> = 314 (115.1 PY)), 48, 34, 27 and 21 patients experienced events of Headache, Pyrexia, Nausea and Dizziness, respectively. All events were non-serious; one patient treated with etrasimod was discontinued due to a Pyrexia TEAE. Numerically, IRs of Headache and Dizziness TEAEs were higher, and Nausea slightly higher, with etrasimod versus placebo (13.45 vs 8.63 per 100 PY, 6.52 vs 1.69 and 7.18 vs 5.13 per 100 PY, respectively); IRs were similar for Pyrexia. The duration of most TEAEs was 1-10 days.</p><p><strong>Conclusion: </strong>In the etrasimod UC clinical programme, all Headache, Pyrexia, Nausea and Dizziness events were non-serious. Headache and Dizziness were more frequent, and Nausea slightly more frequent, among patients receiving etrasimod versus placebo. The post hoc nature of this analysis is a limitation. These results reiterate the favourable safety profile and tolerability of etrasimod.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT02447302; NCT03945188; NCT03996369.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241293643"},"PeriodicalIF":3.9,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11544744/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142630396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effectiveness comparison between ustekinumab and infliximab for Crohn's disease complicated with intestinal stenosis: a multicenter real-world study. 乌司替库单抗和英夫利西单抗治疗并发肠狭窄的克罗恩病的疗效比较:一项多中心真实世界研究。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-10-28 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241290663
Xidong He, Yufang Wang, Jingyao Sun, Yueqin Li, Gechong Ruan, Yue Li, Weiyang Zheng, Xiaolan Zhang, Rongrong Zhan, Xueli Ding, Ailing Liu, Yijia Chen, Yiqun Hu, Hong Yang, Jiaming Qian
{"title":"Effectiveness comparison between ustekinumab and infliximab for Crohn's disease complicated with intestinal stenosis: a multicenter real-world study.","authors":"Xidong He, Yufang Wang, Jingyao Sun, Yueqin Li, Gechong Ruan, Yue Li, Weiyang Zheng, Xiaolan Zhang, Rongrong Zhan, Xueli Ding, Ailing Liu, Yijia Chen, Yiqun Hu, Hong Yang, Jiaming Qian","doi":"10.1177/17562848241290663","DOIUrl":"10.1177/17562848241290663","url":null,"abstract":"<p><strong>Background: </strong>The efficacy of ustekinumab (UST) and infliximab (IFX) in Crohn's disease (CD) patients with intestinal stenosis remains uncertain.</p><p><strong>Objective: </strong>This study aims to compare the efficacy of UST and IFX in the treatment of CD patients with intestinal stenosis.</p><p><strong>Design: </strong>This was a retrospective and multicenter cohort study.</p><p><strong>Methods: </strong>In this retrospective study, we included CD patients treated with IFX or UST at five centers. We assessed the clinical response rate at weeks 12 and 24, steroid-free clinical remission rate at weeks 24 and 52 for overall patients and those with stenosis, and objective examination (intestinal ultrasound and/or endoscopy) response rate at week 52 for stenosis patients.</p><p><strong>Results: </strong>A total of 211 CD patients (106 IFX and 105 UST) were included, with 119 (56 IFX and 63 UST) having intestinal stenosis. In the overall patient population, there were no significant differences in clinical response rate and steroid-free clinical remission rate at weeks 12, 24, and 52 between the IFX and UST groups. In patients with stenosis, the steroid-free clinical remission rate at week 52 was significantly lower in the IFX group compared to the UST group (51.79% IFX vs 69.84% UST, <i>p</i> = 0.044). The objective examination response rate did not significantly differ between the IFX and UST groups at week 52 (66.67% IFX vs 76.19% UST, <i>p</i> = 0.690). In the UST group, steroid-free clinical remission rate was higher in bio-naïve patients than bio-experienced patients at week 24 (75.00% bio-naïve vs 55.38% bio-experienced, <i>p</i> = 0.043).</p><p><strong>Conclusion: </strong>UST may be considered a more advantageous treatment option for those CD patients with intestinal stenosis, as it has better steroid-free clinical remission rates compared to IFX.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241290663"},"PeriodicalIF":3.9,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528754/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142570260","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Assessing age-related risks of gastrointestinal pathologies: a comparative study of gastroscopy outcomes across decades. 评估与年龄相关的胃肠道病变风险:一项跨越数十年的胃镜检查结果比较研究。
IF 3.9 3区 医学
Therapeutic Advances in Gastroenterology Pub Date : 2024-10-28 eCollection Date: 2024-01-01 DOI: 10.1177/17562848241290446
Lac Nguyen, Noora Räsänen, Filippa Berggren, Michiel A van Nieuwenhoven
{"title":"Assessing age-related risks of gastrointestinal pathologies: a comparative study of gastroscopy outcomes across decades.","authors":"Lac Nguyen, Noora Räsänen, Filippa Berggren, Michiel A van Nieuwenhoven","doi":"10.1177/17562848241290446","DOIUrl":"https://doi.org/10.1177/17562848241290446","url":null,"abstract":"<p><strong>Background: </strong>Esophagogastroduodenoscopy (EGD) is the gold standard method for diagnosing upper gastrointestinal (GI) pathology. Swedish guidelines recommend patients over 50 years with new-onset dyspeptic symptoms undergo direct gastroscopy to rule out malignancy. However, the incidence of dysplasia or cancer in patients aged 61-70 years remains unclear.</p><p><strong>Objectives: </strong>To investigate the referral factors and endoscopic findings in patients aged 61-70 years and compare the result with age groups 51-60 and 41-50 years from our previous studies to establish whether there is an age cutoff for upper GI cancer risk.</p><p><strong>Design: </strong>A retrospective observational study was conducted to evaluate EGD referrals and outcomes in patients aged 61-70 years.</p><p><strong>Methods: </strong>We analyzed EGD referrals for patients aged 61-70 years within Region Örebro County from January 2019-April 2020 to January 2022-2023. Clinical data, including symptoms, medications, and laboratory results, were collected from medical records. Statistical analysis, including odds ratios (OR) and positive predictive values (PPV), was conducted to evaluate pathological outcomes based on referral factors.</p><p><strong>Results: </strong>A total of 1003 referrals were analyzed. Statistically significant differences in pathological findings were observed between the 41-50 years reference group and the older groups (51-60 years: OR 2.08, <i>p</i> < 0.001; 61-70 years: OR 3.05, <i>p</i> < 0.001). However, no statistically significant difference in cancer incidence was found between the age groups.</p><p><strong>Conclusion: </strong>The most common pathological findings were benign, including hiatal hernia, gastroesophageal reflux disease/esophagitis, or gastritis. The incidence of cancer was low in all three groups. These results suggest that the \"test-and-treat\" strategy, currently recommended for patients under 50 years, may be appropriate for patients aged 51-70 years as well.</p><p><strong>Trial registration: </strong>NCT04585516.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"17 ","pages":"17562848241290446"},"PeriodicalIF":3.9,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11520010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142548461","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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