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International consensus on the use of intestinal ultrasound in inflammatory bowel disease trials. 在炎症性肠病试验中使用肠道超声的国际共识。
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-18 DOI: 10.1093/ecco-jcc/jjaf170
Mariangela Allocca, Vipul Jairath, Bruce E Sands, David T Rubin, Bénédicte Caron, Valérie Laurent, Kerri Novak, Remo Panaccione, Peter Bossuyt, David H Bruining, Axel Dignass, Iris Dotan, Joel Fletcher, Mathurin Fumery, Federica Furfaro, Jonas Halfvarson, Ailsa Hart, Taku Kobayashi, Noa Krugliak Cleveland, Torsten Kucharzik, Andrea Laghi, Peter L Lakatos, Rupert W Leong, Edward V Loftus, Edouard Louis, Fernando Magro, Pablo A Olivera, Shaji Sebastian, Britta Siegmund, Stephan R Vavricka, Stephanie R Wilson, Jaap Stoker, Jordi Rimola, Laurent Peyrin-Biroulet, Silvio Danese
{"title":"International consensus on the use of intestinal ultrasound in inflammatory bowel disease trials.","authors":"Mariangela Allocca, Vipul Jairath, Bruce E Sands, David T Rubin, Bénédicte Caron, Valérie Laurent, Kerri Novak, Remo Panaccione, Peter Bossuyt, David H Bruining, Axel Dignass, Iris Dotan, Joel Fletcher, Mathurin Fumery, Federica Furfaro, Jonas Halfvarson, Ailsa Hart, Taku Kobayashi, Noa Krugliak Cleveland, Torsten Kucharzik, Andrea Laghi, Peter L Lakatos, Rupert W Leong, Edward V Loftus, Edouard Louis, Fernando Magro, Pablo A Olivera, Shaji Sebastian, Britta Siegmund, Stephan R Vavricka, Stephanie R Wilson, Jaap Stoker, Jordi Rimola, Laurent Peyrin-Biroulet, Silvio Danese","doi":"10.1093/ecco-jcc/jjaf170","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf170","url":null,"abstract":"<p><strong>Background and aims: </strong>Intestinal ultrasound (IUS) is increasingly used to monitor treatment efficacy in inflammatory bowel disease (IBD) trials. However, standardized definitions for response, remission, and optimal assessment timing remain undefined.An international expert consensus meeting was held to establish IUS endpoints for clinical trials.</p><p><strong>Methods: </strong>A panel of 35 international gastroenterologists and radiologists participated in a modified Delphi process, reviewing the literature and developing consensus statements. Agreement was defined as at least 75% consensus.</p><p><strong>Results: </strong>Consensus was reached on 150 statements across four domains: general IBD (30 statements), luminal Crohn's disease (CD) (43), perianal CD (51), and ulcerative colitis (UC) (26). For luminal CD and UC, ultrasound response was defined by: (1) a ≥ 25% reduction in bowel wall thickness (BWT) from baseline, or (2) multifactorial improvement, combining BWT reduction with ≥1 grade decrease in colour Doppler signal (CDS) or another IUS parameter. Assessments were set at weeks 4-8 for the colon and week 12 for the terminal ileum. Ultrasound remission in luminal CD was defined as: (1) BWT normalization (≤3 mm), or (2) normalization of multiple parameters, including BWT, CDS and all other IUS parameters. Similar remission criteria were proposed for UC, but the sigmoid BWT normal range (3-4 mm) remained uncertain. The bowel ultrasound score (BUSS) for CD and the Milan ultrasound criteria (MUC) for UC were supported as standardized scoring system for trials.</p><p><strong>Conclusion: </strong>This consensus provides standardized IUS definitions to enhance consistency in IBD trials, supporting the integration of IUS in future research.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Examining the role of faecal microbiota transplantation for inducing remission in resistant ulcerative proctitis and distal ulcerative colitis (up-FMT). 检查粪便微生物群移植在诱导耐药性溃疡性直肠炎和远端溃疡性结肠炎缓解中的作用。
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-18 DOI: 10.1093/ecco-jcc/jjaf169
Sreecanth S Raja, Samuel P Costello, Chris K Rayner, Alice Day, Laura Portmann, Wendy Uylaki, Reuben Wheeler, Sarah Saxon, Emily C Tucker, James Fon, Suzanne Edwards, Remy B Young, Samuel C Forster, Thomas Goodsall, Robert V Bryant
{"title":"Examining the role of faecal microbiota transplantation for inducing remission in resistant ulcerative proctitis and distal ulcerative colitis (up-FMT).","authors":"Sreecanth S Raja, Samuel P Costello, Chris K Rayner, Alice Day, Laura Portmann, Wendy Uylaki, Reuben Wheeler, Sarah Saxon, Emily C Tucker, James Fon, Suzanne Edwards, Remy B Young, Samuel C Forster, Thomas Goodsall, Robert V Bryant","doi":"10.1093/ecco-jcc/jjaf169","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf169","url":null,"abstract":"<p><strong>Background: </strong>Resistant ulcerative proctitis (UP) represents a clinical conundrum, often necessitating the use of systemic therapy despite the disease being localised. Faecal microbiota transplantation (FMT) has proven efficacy for inducing remission in ulcerative colitis (UC) but has not been evaluated in UP.</p><p><strong>Aims: </strong>To undertake a pilot study examining the safety and efficacy of FMT enema therapy for management of resistant UP.</p><p><strong>Methods: </strong>Patients with mild-moderate active UP (total Mayo 3-10 with endoscopic Mayo subscore ≥ 1) were enrolled. After an initial conditioning phase of vancomycin and dietary education, participants received six anaerobically prepared single-donor FMT retention enemas over 8 weeks. The primary end point was safety and tolerability of FMT therapy. Secondary endpoints included combined clinical and endoscopic remission (Mayo Clinic score ≤2 with endoscopic subscore ≤1), histological remission, patient reported outcomes and exploratory microbial analysis.</p><p><strong>Results: </strong>30 participants were enrolled (median age 41 years; 17 [57%] female). Serious adverse events occurred in 3 patients, including flare of UC (n = 2) and Clostridioides difficile colitis (n = 1). 18 patients (60%) reported mild-moderate adverse events, most commonly gastrointestinal symptoms. Combined clinical and endoscopic remission was achieved in 10 patients (33.3%). Higher baseline Mayo score (OR 0.28, p = 0.008) and faecal calprotectin (OR 0.66, p = 0.049) predicted failure to achieve remission. Participants demonstrated a decrease in Shannon diversity (p = 0.02) following the dual intervention of vancomycin conditioning and FMT.</p><p><strong>Conclusions: </strong>Antibiotic conditioning followed by FMT enema therapy was well tolerated and demonstrated efficacy in inducing clinical remission in UP. Further controlled studies of FMT in UP are warranted alongside mechanistic assessment of both faecal and mucosa-associated microbiome.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Glucagon-Like Peptide (GLP-1) Receptor Agonists in Inflammatory Bowel Disease: Mechanisms, Clinical Implications, and Therapeutic Potential. 胰高血糖素样肽(GLP-1)受体激动剂治疗炎症性肠病:机制、临床意义和治疗潜力。
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-16 DOI: 10.1093/ecco-jcc/jjaf167
Michael Colwill, Sebastian Povlsen, Richard Pollok, Kamal Patel, James Goodhand, Tariq Ahmad, Sailish Honap
{"title":"Glucagon-Like Peptide (GLP-1) Receptor Agonists in Inflammatory Bowel Disease: Mechanisms, Clinical Implications, and Therapeutic Potential.","authors":"Michael Colwill, Sebastian Povlsen, Richard Pollok, Kamal Patel, James Goodhand, Tariq Ahmad, Sailish Honap","doi":"10.1093/ecco-jcc/jjaf167","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf167","url":null,"abstract":"<p><p>Glucagon-like peptide-1 receptor agonists are increasingly recognised for their potential dual benefit in inflammatory bowel disease, offering metabolic advantages alongside emerging anti-inflammatory, immunomodulatory, and gut barrier-enhancing effects. Pre-clinical data demonstrate attenuation of inflammation, preservation of epithelial integrity, and modulation of the microbiome in colitis models. Early retrospective studies in patients with inflammatory bowel disease suggest improved clinical outcomes, such as reduced hospitalisation and surgery rates, particularly in those with obesity. Glucagon-like peptide-1 receptor agonists are already widely used for obesity and diabetes, including increasing self-administration by patients outside medical supervision. Their impact on drug absorption, safety in gastrointestinal disease, and interactions with existing inflammatory bowel disease therapies require further exploration. This review synthesises the mechanistic rationale, pre-clinical evidence, and clinical data to date, highlighting the potential utility and safety considerations of glucagon-like peptide-1 receptor agonists in inflammatory bowel disease and emphasises the need for robust prospective trials to ascertain their safety and efficacy in this patient population.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Subcutaneous vedolizumab dose intensification in inflammatory bowel disease patients: the OPTI-VEDO multicenter study from the GETAID. 炎症性肠病患者皮下vedolizumab剂量强化:来自GETAID的OPTI-VEDO多中心研究
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-10 DOI: 10.1093/ecco-jcc/jjaf166
Pauline Wils, Romain Altwegg, Anthony Buisson, Lucine Vuitton, Stéphane Nancey, Nicolas Richard, Mathurin Fumery, Guillaume Bouguen, Lucas Guillo, Bénédicte Caron, Nicolas Duveau, Carmen Stefanescu, Anne-Laure Pelletier, Catherine Reenaers, Cyrielle Gilletta, Mathieu Uzzan, Nadia Arab, David Laharie, Mathias Vidon, Aurelien Amiot, Catherine Le Berre, Julien Kirchgesner, Olivier Dewit, Marion Simon, Félix Goutorbe, Eric Vicaut, Laurent Peyrin-Biroulet
{"title":"Subcutaneous vedolizumab dose intensification in inflammatory bowel disease patients: the OPTI-VEDO multicenter study from the GETAID.","authors":"Pauline Wils, Romain Altwegg, Anthony Buisson, Lucine Vuitton, Stéphane Nancey, Nicolas Richard, Mathurin Fumery, Guillaume Bouguen, Lucas Guillo, Bénédicte Caron, Nicolas Duveau, Carmen Stefanescu, Anne-Laure Pelletier, Catherine Reenaers, Cyrielle Gilletta, Mathieu Uzzan, Nadia Arab, David Laharie, Mathias Vidon, Aurelien Amiot, Catherine Le Berre, Julien Kirchgesner, Olivier Dewit, Marion Simon, Félix Goutorbe, Eric Vicaut, Laurent Peyrin-Biroulet","doi":"10.1093/ecco-jcc/jjaf166","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf166","url":null,"abstract":"<p><strong>Background and aims: </strong>While this strategy is frequently used for other biologics, real-world evidence on subcutaneous (SC) vedolizumab (VDZ) dose intensification in inflammatory bowel disease (IBD) is lacking. This study aimed to assess the effectiveness and safety of SC VDZ intensification.</p><p><strong>Methods: </strong>We conducted a retrospective study in 25 centers including all patients with active ulcerative colitis (UC) or Crohn's disease (CD) (defined by PRO2), and incomplete or loss of response to SC VDZ 108mg EOW when the drug was intensified. The primary outcome was steroid-free clinical response (SFCr) defined by at least 50% of PRO2 improvement, no treatment change, no surgery, and SC VDZ persistence at 3 months.</p><p><strong>Results: </strong>Out the 154 included patients (66% UC, 34% CD), prior anti-TNF exposure was reported in 85% of CD and 50% of UC patients. SC VDZ was intensified for an incomplete response in 73% of CD and 53% of UC patients, mostly at 108mg weekly (95%). At 3 months, SFCr was achieved in 35% of CD and 43% of UC patients. In multivariate analysis, factors associated with response were secondary loss of response in CD, and prior anti-TNF exposure in UC. At 12 months, 51% of CD and 37% of UC patients maintained SC VDZ. Adverse events occurred in 10 patients including one severe pneumonia and one angioedema.</p><p><strong>Conclusions: </strong>In this real-world study evaluating SC VDZ intensification, a SFCr was observed in at least one third of IBD patients at 3 months, suggesting the benefit of this strategy in clinical practice.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145034756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Blood proteomic signatures associated with disease activity in Inflammatory Bowel Diseases. 与炎症性肠病疾病活动性相关的血液蛋白质组学特征
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-08 DOI: 10.1093/ecco-jcc/jjaf162
Maëva Veyssière, Nassim Hammoudi, Lionel Le Bourhis, Déborah Hassid, Joëlle Bonnet, My-Linh Tran Minh, Clotilde Baudry, Jean-Marc Gornet, Victor Chardiny, Philippe Seksik, Stéphane Nancey, Franck Carbonnel, Xavier Treton, Pauline Wils, Anthony Buisson, Arnaud Boureille, Xavier Hébuterne, Mélanie Serrero, Mathurin Fumery, Edouard Louis, Pierre Blanc, Laurent Peyrin-Biroulet, Madeleine Bezault, Vassili Soumelis, Matthieu Allez
{"title":"Blood proteomic signatures associated with disease activity in Inflammatory Bowel Diseases.","authors":"Maëva Veyssière, Nassim Hammoudi, Lionel Le Bourhis, Déborah Hassid, Joëlle Bonnet, My-Linh Tran Minh, Clotilde Baudry, Jean-Marc Gornet, Victor Chardiny, Philippe Seksik, Stéphane Nancey, Franck Carbonnel, Xavier Treton, Pauline Wils, Anthony Buisson, Arnaud Boureille, Xavier Hébuterne, Mélanie Serrero, Mathurin Fumery, Edouard Louis, Pierre Blanc, Laurent Peyrin-Biroulet, Madeleine Bezault, Vassili Soumelis, Matthieu Allez","doi":"10.1093/ecco-jcc/jjaf162","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjaf162","url":null,"abstract":"<p><strong>Background and aims: </strong>Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), remain heterogeneous disorders with variable response to biologics. Post-operative recurrence in CD is common despite surgery and prophylactic biotherapies. Understanding the inflammatory mediators associated with recurrence and treatment response could pave the way for personalized strategies.</p><p><strong>Methods: </strong>We analyzed serum inflammatory protein signatures using proteomics in two prospective cohorts. The REMIND cohort included post-operative CD patients undergoing ileocecal resection with endoscopic assessment at 6 months (M6). Serum samples were collected at surgery and six months later. The ELYP cohort consisted of active IBD patients starting new biotherapies (anti-TNF, ustekinumab, or vedolizumab). Serum samples were collected pre- and post-treatment (Weeks 14 and 52).</p><p><strong>Results: </strong>In the REMIND cohort, proteomic analysis revealed elevated levels of IFN-γ, CXCL9, and MMP-10 in patients with recurrence, with concentrations associated with recurrence severity. Preoperative MMP-10 levels predicted severe recurrence (AUC = 0.70). Under biotherapies, treatment-specific proteins were associated with recurrence: CXCL9 for anti-TNF and OSM/TGFα modules for ustekinumab. In the ELYP cohort, IFN-γ and CXCL9 were significantly elevated in CD compared to UC and associated with disease activity. Early response to anti-TNF treatment (Week 14) was associated with reductions in CXCL9, MMP-10, and OSM, while deep remission (Week 52) correlated with decreases in CXCL9 and OSM.</p><p><strong>Conclusion: </strong>Our findings reveal inflammatory blood proteomic signatures associated with post-operative recurrence and biologic treatment failure in IBD. Several key biomarkers were identified. These results support the rationale for personalized approaches, including combination therapies targeting multiple pathways.ClincialTrials.gov number, NCT02693340 and NCT02693340.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145016977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Recombinant herpes zoster vaccine lowers shingles complication risk in patients with inflammatory bowel disease. 重组带状疱疹疫苗降低炎症性肠病患者带状疱疹并发症的风险。
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-07 DOI: 10.1093/ecco-jcc/jjaf116
Yichen Wang, Yuting Huang, Jana G Hashash, Tarek Odah, Mary Hayney, Freddy Caldera, Francis A Farraye
{"title":"Recombinant herpes zoster vaccine lowers shingles complication risk in patients with inflammatory bowel disease.","authors":"Yichen Wang, Yuting Huang, Jana G Hashash, Tarek Odah, Mary Hayney, Freddy Caldera, Francis A Farraye","doi":"10.1093/ecco-jcc/jjaf116","DOIUrl":"10.1093/ecco-jcc/jjaf116","url":null,"abstract":"<p><strong>Background: </strong>Patients with inflammatory bowel disease (IBD) are at increased risk of herpes zoster (HZ) infection due to innate immune abnormalities and use of immunosuppressive therapy. The recombinant zoster vaccine (RZV) is recommended, but its efficacy in preventing recurrent HZ among patients with IBD is not well established.</p><p><strong>Methods: </strong>Using data from the TriNetX Linked Network, we conducted a retrospective cohort study of adults (≥18 years) with IBD and a prior uncomplicated HZ episode. Patients with IBD who received RZV were propensity score-matched 1:1 with those who did not. The primary outcome was subsequent HZ complications. Secondary outcomes included subtypes of HZ complications and recurrent uncomplicated HZ. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated via Cox proportional hazards models.</p><p><strong>Results: </strong>After matching, 1260 vaccinated and 1260 unvaccinated patients with IBD were included. Compared to the unvaccinated cohort, patients receiving RZV had a significantly reduced incidence of HZ complications (7.4% vs. 14.5%; HR, 0.75; 95% CI, 0.58-0.97; P = .028). Postherpetic neuralgia was notably decreased (5.8% vs. 12.5%; HR, 0.66; P = .010), and no central nervous system involvement occurred among vaccinated patients. Protective effects were more pronounced in patients with ulcerative colitis, females, and those not receiving immunosuppressive therapy.</p><p><strong>Conclusions: </strong>RZV substantially lowers the risk of HZ complications in patients with IBD, offering significant clinical benefits to those at high risk due to immunosuppression. These findings underscore the importance of RZV as part of preventive care strategies in patients with IBD.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease. 炎症性肠病妊娠管理全球共识声明
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-07 DOI: 10.1093/ecco-jcc/jjaf129
Uma Mahadevan, Cynthia H Seow, Edward L Barnes, María Chaparro, Emma Flanagan, Sonia Friedman, Mette Julsgaard, Sunanda Kane, Siew Ng, Joana Torres, Gillian Watermeyer, Jesus Yamamoto-Furusho, Christopher Robinson, Susan Fisher, Phil Anderson, Richard Gearry, Dana Duricova, Marla Dubinsky, Millie Long
{"title":"Global Consensus Statement on the Management of Pregnancy in Inflammatory Bowel Disease.","authors":"Uma Mahadevan, Cynthia H Seow, Edward L Barnes, María Chaparro, Emma Flanagan, Sonia Friedman, Mette Julsgaard, Sunanda Kane, Siew Ng, Joana Torres, Gillian Watermeyer, Jesus Yamamoto-Furusho, Christopher Robinson, Susan Fisher, Phil Anderson, Richard Gearry, Dana Duricova, Marla Dubinsky, Millie Long","doi":"10.1093/ecco-jcc/jjaf129","DOIUrl":"10.1093/ecco-jcc/jjaf129","url":null,"abstract":"<p><strong>Background & aims: </strong>Pregnancy can be a complex and risk-filled event for women with inflammatory bowel disease (IBD). High-quality studies in this population are lacking, with limited data on medications approved to treat IBD during pregnancy. For patients, limited knowledge surrounding pregnancy impacts pregnancy rates, medication adherence, and outcomes. Limited provider knowledge leads to highly varied practices in care affected by local dogma, available resources, individual interpretation of the literature, and fear of harming the fetus. The variations in guidelines by different societies and countries reflect this and lead to confusion for physicians and patients alike. The Global Consensus Consortium is a group of 39 IBD and content experts and 7 patient advocates from 6 continents who convened to review and assess current data and come to an agreement on best practices based on these data.</p><p><strong>Methods: </strong>The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) process was used when sufficient published data were available and the RAND (Research and Development) process in those instances where expert opinion was needed to guide consistent practice. Recommendations were informed by the guiding principle that maternal health best supports infant health.</p><p><strong>Results: </strong>The topics were divided into ten categories with 34 GRADE recommendations and 35 consensus statements.</p><p><strong>Conclusions: </strong>Overall, the goal of the group was to provide data-driven and practical guidance to improve the care of women with IBD around the globe based on the best available research.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":"19 8","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145008685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimizing the switch from escalated intravenous to subcutaneous infliximab: a population pharmacokinetics-pharmacodynamics study. 优化从静脉注射到皮下注射英夫利昔单抗的转换:一项人群药代动力学-药效学研究。
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-07 DOI: 10.1093/ecco-jcc/jjaf151
Zhigang Wang, Marc Ferrante, Séverine Vermeire, Erwin Dreesen
{"title":"Optimizing the switch from escalated intravenous to subcutaneous infliximab: a population pharmacokinetics-pharmacodynamics study.","authors":"Zhigang Wang, Marc Ferrante, Séverine Vermeire, Erwin Dreesen","doi":"10.1093/ecco-jcc/jjaf151","DOIUrl":"10.1093/ecco-jcc/jjaf151","url":null,"abstract":"<p><strong>Importance and objective: </strong>It remains unclear if patients on escalated intravenous (IV) infliximab can switch to standard subcutaneous (SC) infliximab CT-P13 of 120 mg bi-weekly (Q2W) injections without losing therapeutic response. This study investigates the dose-exposure-response relationship during the IV-to-SC switching of infliximab in Crohn's disease (CD) and ulcerative colitis (UC).</p><p><strong>Design, setting, participants, and intervention(s): </strong>Data were collected from healthy volunteers and patients with CD and UC in different Phase I studies. In patients, PK, fecal calprotectin (FC), and endoscopic remission (ER) in CD or endoscopic improvement (EI) in UC were measured during switching from 5 mg/kg IV infliximab to Q2W SC infliximab injections of 120/180/240 mg. We performed population pharmacokinetics-pharmacodynamics modeling and simulation (n = 1000 virtual patients) to evaluate FC time courses and probabilities of ER/EI post-switch.</p><p><strong>Main outcome(s) and measure(s): </strong>Fecal calprotectin levels decreased when overall infliximab exposure (not just infliximab trough concentrations) increased. Lower FC at week (w)14 was associated with increased probabilities of EI in UC, but not ER in CD. Simulations showed that the standard infliximab IV-to-SC switch at w6 further decreases FC and results in a higher probability of EI at w22/30 (54% if no switch vs 63% if switch). Virtual patients on escalated Q6W/Q8W IV maintenance regimens up to 10 mg/kg can switch to 120 mg Q2W SC infliximab without FC increases. In addition, we translated our model into a clinical software tool to guide the IV-to-SC switch of infliximab.</p><p><strong>Conclusions and relevance: </strong>Patients on Q6W and Q8W IV regimens may switch to standard SC infliximab without an increase in FC.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144983660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Machine learning for predicting Crohn's disease from routine blood tests years before diagnosis: results from the epi-IIRN cohort. 从诊断前几年的常规血液检查中预测克罗恩病的机器学习:来自epi-IIRN队列的结果
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-07 DOI: 10.1093/ecco-jcc/jjaf143
Raffi Lev-Tzion, Amir S Dolev, Shira Yuval Bar-Asher, Ran Balicer, Amir Ben-Tov, Galia Zacay, Eran Matz, Iris Dotan, Dan Turner, Boaz Lerner
{"title":"Machine learning for predicting Crohn's disease from routine blood tests years before diagnosis: results from the epi-IIRN cohort.","authors":"Raffi Lev-Tzion, Amir S Dolev, Shira Yuval Bar-Asher, Ran Balicer, Amir Ben-Tov, Galia Zacay, Eran Matz, Iris Dotan, Dan Turner, Boaz Lerner","doi":"10.1093/ecco-jcc/jjaf143","DOIUrl":"10.1093/ecco-jcc/jjaf143","url":null,"abstract":"<p><strong>Objectives: </strong>In this nationwide study, we used the epi-Israeli Inflammatory Bowel Disease (IBD) Research Nucleus (IIRN) validated cohort to explore the utility of routine blood tests as markers predicting IBD occurrence years before diagnosis.</p><p><strong>Methods: </strong>We included all health maintenance organization (HMO)-insured IBD patients in Israel diagnosed during 2005-2020 to identify discriminative results of blood tests performed up to 15 years before diagnosis. Each patient was individually matched to two non-IBD controls. Means were compared using Welch's t-test with false discovery rate correction to account for multiple comparisons. A machine-learning model was developed using the most significant blood tests to predict future Crohn's disease (CD).</p><p><strong>Results: </strong>Pre-diagnosis results from 84 blood tests were collected for 8630 CD and 6791 ulcerative colitis (UC) patients, including 1162 children with CD and 580 with UC, and their matched controls. Among adults with CD, 29 tests differed consistently from controls earlier than 1 year pre-diagnosis; three showed consistent differences more than 10 years pre-diagnosis. For children, 17 tests differed consistently more than 1 year pre-diagnosis. No tests significantly differed between UC cases and controls. The machine-learning model predicted CD in adults with an area under the curve (AUC) of 0.70 1 year pre-diagnosis and 0.61 7 years pre-diagnosis.</p><p><strong>Conclusion: </strong>We were able to detect changes in routinely collected blood tests long before CD diagnosis and to predict future CD using a machine-learning model, which may be used for developing screening and prediction models for prevention strategies.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144786256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Longitudinal profiles of fecal calprotectin and C-reactive protein in relation to outcomes in Crohn's disease patients on infliximab. 克罗恩病患者服用英夫利昔单抗后,粪便钙保护蛋白和c反应蛋白的纵向分布与预后的关系
IF 8.7
Journal of Crohn's & colitis Pub Date : 2025-09-07 DOI: 10.1093/ecco-jcc/jjaf120
Fernando Magro, Beatriz Domingues, Maria Manuela Estevinho, Marta Patita, Bruno Arroja, Paula Lago, Isadora Rosa, Helena Tavares de Sousa, Paula Ministro, Irina Mocanu, Ana Vieira, Joana Castela, Joana Moleiro, Joana Roseira, Eugénia Cancela, Paula Sousa, Francisco Portela, Luís Correia, Samuel Fernandes, Claudia Camila Dias, Sandra Dias, Laurent Peyrin-Biroulet, Silvio Danese, Mafalda Santiago
{"title":"Longitudinal profiles of fecal calprotectin and C-reactive protein in relation to outcomes in Crohn's disease patients on infliximab.","authors":"Fernando Magro, Beatriz Domingues, Maria Manuela Estevinho, Marta Patita, Bruno Arroja, Paula Lago, Isadora Rosa, Helena Tavares de Sousa, Paula Ministro, Irina Mocanu, Ana Vieira, Joana Castela, Joana Moleiro, Joana Roseira, Eugénia Cancela, Paula Sousa, Francisco Portela, Luís Correia, Samuel Fernandes, Claudia Camila Dias, Sandra Dias, Laurent Peyrin-Biroulet, Silvio Danese, Mafalda Santiago","doi":"10.1093/ecco-jcc/jjaf120","DOIUrl":"10.1093/ecco-jcc/jjaf120","url":null,"abstract":"<p><strong>Background and aims: </strong>This study explored the relationship between fecal calprotectin (FCAL) and C-reactive protein (CRP) trajectory classes and composite outcomes (COs) in Crohn's disease (CD) patients under infliximab (IFX). COs reflected disease progression, including surgery, hospitalizations, new fistulas, abscesses, strictures, and treatment escalation.</p><p><strong>Methods: </strong>The DIRECT study was a multicenter, prospective investigation (2016-2019), including moderate-severe CD patients on IFX. Latent class mixed models were used to identify subgroups based on longitudinal FCAL and CRP trajectories.</p><p><strong>Results: </strong>FCAL trajectory analysis identified four clusters; CRP analysis revealed three. Patients in the U-shaped FCAL trajectory (Class 1) were more likely to achieve the global CO [odds ratio (OR) 3.263, 95% confidence interval (CI) 1.050-10.144, P = .041] and the CO without symptoms and IFX adjustments compared to those in the subthreshold decline (Class 4) (OR 9.639, 95% CI 1.147-81.025, P = .037). In CRP trajectories, patients in the upward trend (Class C) had a higher odds of achieving the global CO compared to the flat trajectory (Class B) (OR 2.171, 95% CI 1.059-4.449, P = .034). In multivariable regression models, class membership improved composite outcome discrimination.</p><p><strong>Conclusions: </strong>Patients under IFX therapy with near or above-threshold FCAL levels or a history of high CRP were more likely to experience adverse outcomes. Regression analyses demonstrated that class membership provided additional prognostic value beyond baseline variables alone. These findings highlight the clinical relevance of trajectory-based monitoring for optimizing treatment strategies and underscore the importance of controlling inflammation early to prevent disease progression in CD.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":" ","pages":""},"PeriodicalIF":8.7,"publicationDate":"2025-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144839464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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