Therapeutic Advances in Gastroenterology最新文献

{"title":"Study design of the phase IV, randomized, placebo-controlled REMOdeling with Dupilumab in Eosinophilic esophagitis Long-term (REMODEL) trial.","authors":"Evan S Dellon, Edoardo V Savarino, Sherif Zaghloul, James T Angello, Mei Zhang, Bram P Raphael, Amr Radwan, Albert J Bredenoord","doi":"10.1177/17562848251383782","DOIUrl":"10.1177/17562848251383782","url":null,"abstract":"<p><strong>Background: </strong>Esophageal distensibility, measured by endoluminal functional lumen imaging probe (EndoFLIP), identifies esophageal fibrostenotic changes and is impaired in patients with eosinophilic esophagitis (EoE). Early-phase clinical trials suggested dupilumab could increase esophageal distensibility. However, there are limited data on the long-term impact of dupilumab treatment on fibrostenosis.</p><p><strong>Objectives: </strong>To evaluate the long-term efficacy of dupilumab, including its impact on esophageal fibrostenotic progression, in adult patients with EoE.</p><p><strong>Design: </strong>The phase IV study is comprised of a randomized, double-blind, placebo-controlled trial period for 24 weeks, followed by an open-label extension for 104 weeks.</p><p><strong>Methods and analysis: </strong>In total, 69 adult patients with endoscopically and histologically active EoE have been recruited from 30 global sites and randomized 2:1 to receive dupilumab 300 mg once weekly (qw) or placebo during the double-blind treatment period. Eligible patients continuing into the open-label extension period will receive dupilumab 300 mg qw. The primary endpoint is absolute change from baseline in esophageal distensibility plateau at week (W)24 measured by EndoFLIP. Secondary endpoints include change in esophageal distensibility plateau at W76 and W128; histologic, endoscopic, and molecular features of EoE at W24, W76, and W128; and long-term safety. After the double-blind treatment period, endpoints will be summarized with descriptive statistics.</p><p><strong>Ethics: </strong>REMODEL will be conducted in accordance with the Declaration of Helsinki, the Council for International Organizations of Medical Sciences international ethical guidelines, and the International Council for Harmonisation Good Clinical Practice guidelines. The protocol was approved by an institutional review board before study initiation.</p><p><strong>Discussion: </strong>REMODEL will address whether long-term dupilumab treatment can mitigate fibrostenotic progression in patients with EoE and may provide new insights into the roles of interleukin-4 and -13 in the pathophysiology and progression of EoE.</p><p><strong>Trial registration: </strong>All patients will provide informed consent. REMODEL was registered on ClinicalTrials.gov (NCT06101095) on October 19, 2023.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251383782"},"PeriodicalIF":3.4,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12515341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145287287","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}

{"title":"Comparative analysis of sporadic, IBD-associated, early-onset and late-onset colorectal cancer: a systematic review and meta-analysis.","authors":"Giacomo Fuschillo, Olga Maria Nardone, Giulio Calabrese, Marc Martí-Gallostra, Francesco Selvaggi, Eloy Espín-Basany, Gianluca Pellino, Jose Perea","doi":"10.1177/17562848251379961","DOIUrl":"10.1177/17562848251379961","url":null,"abstract":"<p><strong>Background: </strong>Colorectal cancer (CRC) remains a multifaceted disease with variations in aetiology, clinical presentation and prognostic factors.</p><p><strong>Objectives: </strong>This study explores the features and outcomes of sporadic (S-CRC), inflammatory bowel disease-associated CRC (IBD-CRC), early-onset CRC (EO-CRC) and late-onset CRC (LO-CRC).</p><p><strong>Design: </strong>This is a systematic review and meta-analysis performed following the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) Statement, comparing S-CRC versus IBD-CRC and EO-CRC versus LO-CRC.</p><p><strong>Data sources and methods: </strong>The literature search was conducted on PubMed and Embase databases. The primary endpoint was the overall 5-year survival rate of CRC. Secondary aims included the features of CRC at diagnosis.</p><p><strong>Results: </strong>Fifty studies and 6,148,851 patients with CRC were included in the analysis. Comparing S-CRC and IBD-CRC, the overall survival was higher in S-CRC (61.88 (range 41.3-78.7) vs 55.54 (51.9-80.9) months). IBD-CRC showed a minor mean age of diagnosis (63.5 (45-78) vs 69.1 ((40-78) years), a minor risk of stage IV (odd ratio (OR) 1.091; 95%CI 1.031-1.155, <i>p</i> = 0.003, <i>I</i> ² 60.24%), higher risk of mucinous tumour (OR 3.150 95%CI 2.797-3.548, <i>p</i> < 0.001, <i>I</i> ² 96.56%), emergency diagnosis (OR 1.598, 95%CI 1.509-1.693, <i>p</i> < 0.001, <i>I</i> ² 77.40%), and synchronous neoplasia (OR 1.942 95%CI 1.705-2.211, <i>p</i> < 0.001, <i>I</i> ² 0.00%). Comparing EO-CRC and LO-CRC, OS was longer in EO-CRC (79.42 (54-96) vs 77.58 (32-92) months). EO-CRC had a higher risk of being diagnosed at stage IV (OR 1.471, 95%CI 1.456-1.486, <i>p</i> < 0.001, <i>I</i> ² 97.12%), and of having mucinous tumours (OR 1.0142, 95%CI 1.015-1.070, <i>p</i> = 0.002, <i>I</i> ² 60.48%) versus LO-CRC. Comparing IBD-CRC, EO-CRC and LO-CRC, IBD-CRC had the shortest OS (61.88 months), the highest rate of mucinous cancer (13%) and emergency diagnosis (24%), whereas metastatic disease at diagnosis was more common in EO-CRC (22.6%).</p><p><strong>Conclusion: </strong>IBD-CRC was associated with a younger mean age at diagnosis, higher risk of mucinous cancers, emergency presentation, and synchronous neoplasia compared to S-CRC. EO-CRC had a higher risk of being diagnosed at stage IV and of mucinous tumours versus LO-CRC. IBD-CRC seemed to have an overall shorter survival rate and a higher prevalence of mucinous cancers, suggesting different pathways of progression and more aggressive features.</p><p><strong>Trial registration: </strong>Prospero Registration ID1021182.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251379961"},"PeriodicalIF":3.4,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12515334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145287277","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}

{"title":"Utility of oral rehydration jelly in probe method endoscopic ultrasound: a prospective cohort study.","authors":"Shinya Yamada, Hajime Takatori, Masaki Miyazawa, Tomoyuki Hayashi, Akihiro Seki, Hidetoshi Nakagawa, Kouki Nio, Noriho Iida, Tetsuro Shimakami, Taro Yamashita","doi":"10.1177/17562848251385069","DOIUrl":"10.1177/17562848251385069","url":null,"abstract":"<p><strong>Background: </strong>When performing endoscopic ultrasound (EUS) using a miniature probe, filling the lumen with water is necessary. However, because of gravity and peristalsis, satisfactory images are often not obtained. Recently, it has been reported that injecting a viscous gel instead of water could facilitate EUS imaging.</p><p><strong>Objectives: </strong>To determine if EUS performed with rehydration jelly returned interpretable images when the standard method did not.</p><p><strong>Design: </strong>Prospective cohort study.</p><p><strong>Methods: </strong>EUS was first attempted in 50 patients using the conventional water-filling method; in cases where satisfactory images were not obtained, EUS was additionally performed using oral rehydration jelly (OS-1). Five endoscopists evaluated the obtained images, and their outcomes were examined.</p><p><strong>Results: </strong>Satisfactory images were not obtained in 34 cases when using the water-filling method. The images obtained using the jelly method were improved compared to the water-filling method in 29 cases, with a significant improvement in 18 cases. No complications were observed with the jelly method.</p><p><strong>Conclusion: </strong>For EUS, the jelly method will likely yield good images when satisfactory image quality cannot be obtained using the water-filling method.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251385069"},"PeriodicalIF":3.4,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12515324/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145287288","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}

{"title":"Gastroenterologists' attitudes and challenges toward treat-to-target strategies in inflammatory bowel disease: a multinational survey.","authors":"Zhilan You, Jun Shen, Vineet Ahuja, Gillian Watermeyer, Flavio Steinwurz, Marina Shapina, Claudio Fiocchi, Zhihua Ran","doi":"10.1177/17562848251383792","DOIUrl":"10.1177/17562848251383792","url":null,"abstract":"<p><strong>Background: </strong>To standardize the treatment of inflammatory bowel disease (IBD) by establishing clear treatment targets and optimizing management strategies, the International Organization for the Study of IBD has proposed a treat-to-target (T2T) approach, which is now a popular management paradigm for IBD. However, this paradigm, which was derived primarily from Western countries with a high prevalence of IBD, has not been adopted universally. There is limited information on how T2T strategies are implemented around the world, and particularly in countries where IBD is a more recent phenomenon and has lower prevalence.</p><p><strong>Objectives: </strong>The aim of this study was to take advantage of the existence of the BRICS IBD Consortium (Brazil, Russia, India, China, and South Africa), a newly formed multinational organization, to get a realistic appraisal of gastroenterologists' attitudes concerning the IBD treatment strategies.</p><p><strong>Design: </strong>A 59-question online questionnaire was distributed to 227 gastroenterologists from the BRICS countries between February and April 2024.</p><p><strong>Methods: </strong>Data on gastroenterologists' characteristics, treatment strategies, and adoption of the STRIDE (Selecting Therapeutic Targets in Inflammatory Bowel Disease)-II consensus were collected, focusing primarily on viewpoints and challenges toward IBD T2T strategies.</p><p><strong>Results: </strong>More than 70% of respondents considered clinical and endoscopic remission, improved quality of life, absence of disability, and restoration of normal growth in children as the most important goals for IBD treatment. Concerns and challenges raised toward the International Organization for the Study of IBD (IOIBD) T2T strategy were the lack of a validated definition of mucosal healing (66.1%), guidelines conflicted with clinical experience (40.1%), psychological comorbidities (89.4%), loss of response to medical therapy (74.9%), complications associated with penetrating Crohn's disease (CD; 74%), fistulising perianal CD (67.4%), and high out-of-pocket costs of therapeutic drug monitoring (69.6%). A step-up strategy was preferred (89%) in mild-to-moderate ulcerative colitis, whereas a top-down strategy was selected by the majority (72.2%) of respondents for CD management. Overall, the BRICS survey indicated that most of the participants had relatively high confidence in the IOIBD T2T recommendations.</p><p><strong>Conclusion: </strong>Although various concerns were identified, the BRICS survey showed that T2T strategies for IBD have been generally well received but not universally adopted by most gastroenterologists in countries with the more recent emergence of IBD.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251383792"},"PeriodicalIF":3.4,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12515296/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145287279","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}

{"title":"Comparing the treatment effects of online cognitive-behavioral therapy for pediatric functional abdominal pain disorders with and without psychiatric comorbidity.","authors":"Viktor Vadenmark Lundqvist, Aleksandra Bujacz, Jenny Rickardsson, Johan Åhlén, Martin Jonsjö, Jörgen Rosén, Sarah Vigerland, Karin Jensen, Marianne Bonnert, Maria Lalouni","doi":"10.1177/17562848251384605","DOIUrl":"10.1177/17562848251384605","url":null,"abstract":"<p><strong>Background: </strong>Functional abdominal pain disorders (FAPDs) are disorders of the gut-brain interaction. FAPDs are common in children and adolescents (global prevalence 12%) and are associated with psychiatric comorbidity. Internet-delivered cognitive-behavioral therapy (iCBT) is effective for FAPDs, but it's unclear whether children with psychiatric comorbidities benefit equally from the treatment.</p><p><strong>Objectives: </strong>In this study, we assessed whether having a comorbid psychiatric diagnosis results in different rates of change in iCBT for children with FAPDs.</p><p><strong>Design: </strong>Between-groups design.</p><p><strong>Methods: </strong>Participants were 120 children with FAPDs (age 8-12 years) taking part in one of two clinical trials testing 10 weeks of iCBT. For the analyses, participants were divided into groups: presence or absence of psychiatric disorder. The primary outcome was gastrointestinal symptoms, assessed weekly using the Pediatric Quality of Life Gastrointestinal Symptom Scale. Secondary outcomes included health-related quality of life, gastrointestinal-specific anxiety, and pain intensity. Multilevel modeling was used to assess differences in rates of change between groups from baseline to follow-up directly after treatment, and then to 6-month follow-up.</p><p><strong>Results: </strong>We observed significant improvements in the rates of change for both groups for the primary outcome (gastrointestinal symptoms) and all secondary outcomes during treatment. Children with psychiatric comorbidity had significantly more severe symptoms at baseline on all measures, but there was no difference in the rates of change for the primary outcome (-0.29, 95% confidence interval (CI): -0.70, 0.11, <i>p</i> = 0.159) or any of the secondary outcomes compared to the non-comorbid group. Treatment benefits were sustained at 6-month follow-up.</p><p><strong>Conclusion: </strong>ICBT seems to be beneficial for children with FAPDs, also in the presence of psychiatric comorbidity. Given the high prevalence of psychiatric comorbidity in this patient group, the results will aid the clinical assessment and treatment planning for these patients.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251384605"},"PeriodicalIF":3.4,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12515282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145287278","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}

{"title":"Real-world-data on efficacy and safety of topical budesonide therapy (orodispersible tablet) in induction and maintenance therapy in adult patients with active eosinophilic esophagitis.","authors":"Maja Weisfeld, Stephan Miehlke, Silke Meszaros, Verena Keitel-Anselmino, Ulrike von Arnim","doi":"10.1177/17562848251382791","DOIUrl":"10.1177/17562848251382791","url":null,"abstract":"<p><strong>Background: </strong>Eosinophilic esophagitis (EoE) is a chronic, progressive, immune-mediated disease of the esophagus. Esophageal dysfunction in solid food dysphagia combined with eosinophil-dominant inflammation (⩾15 eos/high-power-field (hpf)) serves as diagnostic criteria. Treatment objectives for active EoE include induction and maintenance of clinical-histological remission. Topical budesonide therapy in the form of an orodispersible tablet (BUD-ODT) has shown effectiveness in both scenarios.</p><p><strong>Objectives: </strong>To examine the efficacy and safety of BUD-ODT therapy in adults with active EoE in a Real-World-Setting.</p><p><strong>Design: </strong>This retrospective study from two German EoE centers examined the efficacy and safety of BUD-ODT therapy in adults with active EoE between June 2018 and August 2022.</p><p><strong>Methods: </strong>Patient demographics, clinical characteristics, and EoE history were extracted from medical records. Evaluations included clinical (Straumann Dysphagia Index, range: 0-9, remission: ⩽3 points), histological (remission: ⩽15 eos/hpf), and endoscopic assessment (endoscopic reference scoring system (EREFS) score, range: 0-9, remission: ⩽2 points). Three periods were analyzed: Induction phase (induction therapy (IT): 1 mg BID, 6-12 weeks; <i>n</i> = 201), maintenance phase I (RM1: 0.5 mg BID or 1 mg QD, 14-24 weeks; <i>n</i> = 109), and maintenance phase II (RM2: same dosage as RM1, 52-104 weeks; <i>n</i> = 72).</p><p><strong>Results: </strong>A total of 221 adults with clinical-histologically proven active EoE were included. Clinical-histological remission was achieved in 75.1% (151/201) of patients after IT, maintained in 73.4% (80/109) after RM1, and in 76.4% (55/72) after RM2. The relapse rate was 26.6% (29/109) after RM1 and 23.6% (17/72) after RM2. Those patients underwent re-induction therapy for 6-8 weeks and were re-evaluated separately (remission: 36.0% after RM1 and 46.2% after RM2). Endoscopic remission was demonstrated in 88.1% (177/201) after IT. The most prevalent side effect was endoscopically detected combined oral-esophageal candidiasis.</p><p><strong>Conclusion: </strong>BUD-ODT demonstrated high effectiveness in inducing and maintaining remission in a real-world setting. The spectrum of side effects did not reveal any new aspects compared to known clinical data.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251382791"},"PeriodicalIF":3.4,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145281430","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}

{"title":"Parental distress and symptom severity in referred youths with functional abdominal pain disorders: a cross-sectional study prior to internet-based cognitive behavioral therapy.","authors":"Eva Skovslund Nielsen, Karen Hansen Kallesøe, Anne Sofie Hansen, Lisbeth Frostholm, Maria Lalouni, Marianne Bonnert, Charlotte Ulrikka Rask","doi":"10.1177/17562848251383414","DOIUrl":"10.1177/17562848251383414","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Parental psychological and behavioral factors may influence outcomes in youths with functional abdominal pain disorders (FAPDs), yet limited research has explored these associations in families referred for hospital-based psychological treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;To describe parental emotional and behavioral factors in families referred to internet-based cognitive behavioral therapy (ICBT) for FAPDs, and examine their associations with youth-reported outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design: &lt;/strong&gt;Cross-sectional exploratory study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Eighty-seven parent-youth dyads (youth aged 8-17 years) enrolled in an ICBT intervention study at a Danish hospital participated. Parental factors included emotional distress (SCL-8), health anxiety by proxy (HAPYs), and behavioral responses (Adult Responses to Child Symptoms Monitor and Protect subscales). Youth-reported outcomes included gastrointestinal symptoms (Pediatric Quality of Life Gastrointestinal Symptom Scale (PedsQL-Gastro)), pain intensity (Faces Pain Rating Scale-Revised), quality of life (PedsQL), gastrointestinal-anxiety (Visceral Sensitivity Index-Child adapted short scale), and avoidance/control behaviors (BRQ-C). Associations were examined using Spearman's correlations and hierarchical linear regression models, adjusting for all parental factors and youth sex.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Most parents were mothers, highly educated, employed, cohabiting, with a middle to high household income. They generally reported low emotional distress, moderate health anxiety by proxy (HAPY) and monitoring behavior, and low protective behavior. Parental emotional distress and HAPY were significantly correlated with lower youth-reported quality of life and higher gastrointestinal-specific anxiety, particularly among adolescents. Monitoring behavior correlated with greater pain intensity, especially in children. In adjusted analyses, higher emotional distress remained significantly associated with lower youth-reported quality of life (β = -0.95, &lt;i&gt;p&lt;/i&gt; = 0.02) and higher gastrointestinal-specific anxiety (β = 0.63, &lt;i&gt;p&lt;/i&gt; = 0.008). Monitoring behavior remained significantly associated with greater youth-reported pain intensity (β = 0.22, &lt;i&gt;p&lt;/i&gt; = 0.01). HAPY and protective behavior showed no significant independent associations with adverse youth outcomes. However, in age-stratified analyses, protective behavior was associated with fewer gastrointestinal symptoms in adolescents (β = 2.84, &lt;i&gt;p&lt;/i&gt; = 0.02). No notable significant sex differences were observed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Parental emotional distress and monitoring behavior were the most consistent parental factors associated with adverse youth outcomes and may represent key targets in intervention for pediatric FAPDs. The potential protective role of certain parental behaviors in adolescents warrants further exploration. Findings should be replicated in large","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251383414"},"PeriodicalIF":3.4,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145281483","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}

{"title":"Treatment discontinuation rates due to lack of efficacy through 1 year of maintenance treatment with vedolizumab or subcutaneous infliximab in patients with inflammatory bowel disease: a systematic literature review and meta-analysis.","authors":"Marc Ferrante, Laurent Peyrin-Biroulet, Perttu Arkkila, Alessandro Armuzzi, Jean-Frédéric Colombel, Silvio Danese, Roberto Faggiani, Jordi Guardiola, Stephen B Hanauer, Jorgen Jahnsen, Walter Reinisch, Xavier Roblin, Philip J Smith, Taek Sang Kwon, Seungmin Kim, Kyoungwan Nam, Raja Atreya","doi":"10.1177/17562848251383767","DOIUrl":"10.1177/17562848251383767","url":null,"abstract":"<p><strong>Background: </strong>Infliximab (IFX) and vedolizumab (VDZ), frequently used biologics in inflammatory bowel disease (IBD), are available as intravenous (IV) and subcutaneous (SC) formulations; however, comparative data are limited.</p><p><strong>Objectives: </strong>To compare the rates of discontinuation due to lack of efficacy during maintenance treatment with infliximab (subcutaneous) and vedolizumab (intravenous and subcutaneous) in patients with moderate-to-severe IBD.</p><p><strong>Design: </strong>Systematic literature review and meta-analysis.</p><p><strong>Data sources and methods: </strong>Three medical databases, PubMed, Embase, and the Cochrane Library, were systematically searched from January 2010 to May 2024 to identify phases I-III randomized controlled trials. The primary outcome was discontinuation of study drug due to lack of efficacy (per definitions used in the included studies) during maintenance treatment (PROSPERO number CRD42023438330). Rates of discontinuation due to adverse events during maintenance treatment were examined in additional exploratory analyses.</p><p><strong>Results: </strong>We identified three eligible clinical trials in IBD for subcutaneous infliximab (591 patients) and five for vedolizumab (intravenous and subcutaneous formulations; 2117 patients). Rates of discontinuation due to lack of efficacy (per individual study definition) were significantly lower in patients treated with subcutaneous infliximab (0.05 (95% confidence interval (CI): 0.03, 0.06)) than in patients treated with vedolizumab (0.29 (95% CI: 0.20, 0.38)); rates remained significantly lower with subcutaneous infliximab versus vedolizumab, respectively, in the subgroups of patients with Crohn's disease (0.05 (95% CI: 0.02, 0.07) vs 0.37 (95% CI: 0.27, 0.47)) or ulcerative colitis (0.05 (95% CI: 0.02, 0.07) vs 0.24 (95% CI: 0.11, 0.36)). Rates of discontinuation due to adverse events were lower in subcutaneous infliximab-treated patients (0.04 (95% CI: 0.02, 0.05) than in vedolizumab-treated patients (0.08 (95% CI: 0.05, 0.11)).</p><p><strong>Conclusion: </strong>In this meta-analysis, rates of discontinuation due to lack of efficacy during maintenance treatment were lower with subcutaneous infliximab than with vedolizumab (intravenous and subcutaneous formulations) in patients with moderate-to-severe IBD.</p><p><strong>Trial registration: </strong>PROSPERO number CRD42023438330.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251383767"},"PeriodicalIF":3.4,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511697/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145281425","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}

{"title":"Adalimumab around the world: comparative analysis of products characteristics and patient support systems.","authors":"Tsz Hong Yiu, Emilia Anderson, Wai Keung Leung, Hiroshi Nakase, Rupa Banerjee, Huiyu Lin, Christopher Ma, Fernando Magro, Stacy Tse, Bruce E Sands, Christian Selinger, Rupert W Leong","doi":"10.1177/17562848251358168","DOIUrl":"10.1177/17562848251358168","url":null,"abstract":"<p><p>Following the expiration of the adalimumab originator patent, there has been a rapid increase in the availability and uptake of adalimumab biosimilars. While chemically and clinically similar in effects, there are substantial non-pharmacological differences in these products. This global review compares the originator versus currently available adalimumab biosimilars, focusing on variations in formulations and patient support systems across different countries. The goal is to provide prescribers with guidance on selecting the most appropriate products. Data on adalimumab biosimilars were collected from global medication registries and Product Information documents, supplemented by direct inquiries to pharmaceutical companies, with data collection completed in September 2024. Experts from nine countries assessed the local patient support system and collaborated to illustrate the diversity of adalimumab. Including the originator, there are 29 adalimumab products available globally. We highlighted products with favorable characteristics, including delivery device, concentration, citrate content, the range of dosages, latex content, and shelf life. Patient support services helped to differentiate these products further, to capture market share. Among the reviewed countries, Australia, the United States, and Canada offered the most comprehensive patient support systems, including injection training, reminders, as well as nursing and other patient support services. This review highlights the global diversity of adalimumab products, emphasizing key usability factors, such as formulation, dosing flexibility, shelf life, and patient support. A comparative table is provided to aid clinicians in selecting the most appropriate option based on individual patient needs.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251358168"},"PeriodicalIF":3.4,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12497974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245681","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}

{"title":"Higher ustekinumab concentrations in induction are associated with better endoscopic outcomes in inflammatory bowel disease.","authors":"Xavier Serra-Ruiz, Elena Céspedes-Martínez, Luis Mayorga, Claudia Herrera-deGuise, Virginia Robles, Ernesto Lastiri, Sonia Garcia-Garcia, María Larrosa-García, María Teresa Sanz-Martínez, Zahira Pérez, Elena Oller, Natalia Borruel","doi":"10.1177/17562848251378067","DOIUrl":"10.1177/17562848251378067","url":null,"abstract":"<p><strong>Background: </strong>Evidence suggests a relationship between ustekinumab (UST) concentrations and therapeutic outcomes in inflammatory bowel disease.</p><p><strong>Objectives: </strong>This study aimed to evaluate the association between UST concentrations during the induction phase and treatment outcomes at week 24 in patients with Crohn's disease (CD) and ulcerative colitis (UC). The primary outcome was endoscopic remission at week 24, defined as a simple endoscopic score (SES-CD) ⩽2 for CD and a Mayo endoscopic score = 0 for UC. Secondary outcomes included endoscopic response, clinical remission, and treatment persistence.</p><p><strong>Design: </strong>This was a prospective observational study assessing clinical and endoscopic outcomes in CD and UC patients starting UST therapy.</p><p><strong>Methods: </strong>Consecutive patients with CD and UC were included at the initiation of UST treatment. Trough UST concentrations were measured at weeks 8, 16, and 24 after the first intravenous dose, and the main outcomes were assessed at week 24. Endoscopic and clinical parameters were used to evaluate treatment efficacy and persistence.</p><p><strong>Results: </strong>Seventy patients (45 with CD) were enrolled. Those achieving endoscopic remission and response at week 24 had higher UST levels at week 8 (4.5 vs 2.6 μg/mL, <i>p</i> = 0.0028; 4.1 vs 2.4 μg/mL, <i>p</i> = 0.0024, respectively). Patients with UST concentrations in the fourth quartile (Q4) at week 8 (>4.5 μg/mL) had higher rates of endoscopic remission (66.7% (Q4) vs 20% (Q1); 33.3% (Q2); 28.6% (Q3); <i>p</i> = 0.012). A UST concentration threshold of 4.5 μg/mL at week 8 was the best predictor of endoscopic remission (AUC = 0.7, sensitivity 54.5%, specificity 83.8%), while 3.5 μg/mL predicted endoscopic response (AUC = 0.732, sensitivity 53.8%, specificity 87%). Longer disease duration correlated with a higher risk of UST discontinuation (odds ratio, 1.034, 95% confidence interval, 1.002-1.068, <i>p</i> = 0.035). Higher UST concentrations in Q4 did not result in greater drug persistence (<i>p</i> = 0.319).</p><p><strong>Conclusion: </strong>UST concentrations at week 8 were positively associated with endoscopic outcomes at week 24, with a threshold of 4.5 μg/mL reliably predicting endoscopic remission. Further randomized clinical trials are warranted to explore whether optimizing UST treatment based on post-induction concentrations can enhance therapeutic outcomes.</p>","PeriodicalId":48770,"journal":{"name":"Therapeutic Advances in Gastroenterology","volume":"18 ","pages":"17562848251378067"},"PeriodicalIF":3.4,"publicationDate":"2025-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12497976/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245316","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}