Journal of Crohn's & colitis最新文献

{"title":"Labour market participation and income in patients with IBD onset before young adulthood - the role of disease severity and mental health.","authors":"Julie Rasmussen, Bente Mertz Nørgård, Henrik Bøggild, Niels Qvist, Åsa H Everhov, Petter Malmborg, Rasmus Gaardskær Nielsen, René Børge Korsgaard Brund, Kirsten Fonager","doi":"10.1093/ecco-jcc/jjae165","DOIUrl":"https://doi.org/10.1093/ecco-jcc/jjae165","url":null,"abstract":"<p><strong>Background and aim: </strong>Only few studies have examined the socioeconomic consequences of being diagnosed with inflammatory bowel disease (IBD) in childhood or youth. Disease severity has been linked to lower earnings, but little attention has been paid to comorbid mental health conditions. The aim is to examine labour market participation (LMP) and income in patients with IBD-onset in childhood or youth and examine how disease severity and mental health conditions affects LMP.</p><p><strong>Methods: </strong>In this register-based cohort study, we included patients with IBD-onset before 25 years of age and matched comparators. We estimated the relative risk (RR) of having low LMP and the median yearly income from ages 26 to 30. RR of low LMP was also assessed in subgroups of patients based on disease severity (severe/non-severe) and mental health conditions (yes/no).</p><p><strong>Results: </strong>A total of 3,398 patients with IBD and 28,207 comparators were included. Overall, patients with IBD more often had low LMP (16.4% vs 14.4% in comparators), but slightly higher income (median yearly income difference at age 30: 1,141 Euro [95% CI: 483-1,798]). In subgroup analyses, only patients with severe IBD had higher risk of low LMP (RR 1.46 [95% CI 1.23-1.72]), not patients with non-severe IBD. Among patients with severe disease and mental health conditions 46% had low LMP (RR 5.03 [95% CI 4.38-5.78]).</p><p><strong>Conclusion: </strong>Patients with IBD more often had low LMP, but their income was not affected. The subgroup of patients with severe disease and mental health conditions had the highest risk of low LMP.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142577103","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}

{"title":"Impact of Prior Biologic or Janus Kinase Inhibitor Therapy on Efficacy and Safety of Etrasimod in the ELEVATE UC 52 and ELEVATE UC 12 Trials.","authors":"Séverine Vermeire, Bruce E Sands, Laurent Peyrin-Biroulet, Geert R D'Haens, Julian Panés, Andres J Yarur, Douglas C Wolf, Timothy Ritter, Stefan Schreiber, John C Woolcott, Irene Modesto, Michael Keating, Kevin Shan, Joseph Wu, Michael V Chiorean, Filip Baert, Marla C Dubinsky, Martina Goetsch, Silvio Danese, Brian G Feagan","doi":"10.1093/ecco-jcc/jjae079","DOIUrl":"10.1093/ecco-jcc/jjae079","url":null,"abstract":"<p><strong>Background and aims: </strong>Etrasimod is an oral, once daily, selective, sphingosine 1-phosphate [S1P]1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis [UC]. This subgroup analysis evaluated the efficacy and safety of etrasimod 2 mg once daily vs placebo by prior biologic/Janus kinase inhibitor [bio/JAKi] exposure in ELEVATE UC 52 and ELEVATE UC 12.</p><p><strong>Methods: </strong>Pre-defined efficacy endpoints were assessed at Weeks 12 and 52 in ELEVATE UC 52 and Week 12 in ELEVATE UC 12 in bio/JAKi-naïve and -experienced patients, and at Week 12 [pooled] based on prior advanced therapy exposure mechanism.</p><p><strong>Results: </strong>In the ELEVATE UC 52 and ELEVATE UC 12 analysis populations, 80/274 [29.2%] and 74/222 [33.3%] patients receiving etrasimod and 42/135 [31.1%] and 38/112 [33.9%] patients receiving placebo, respectively, were bio/JAKi-experienced. In both bio/JAKi-naïve and -experienced patients, a significantly greater proportion receiving etrasimod vs placebo achieved clinical remission [p < 0.05] in ELEVATE UC 52 at Weeks 12 [naïve: 30.9% vs 9.7%; experienced: 17.5% vs 2.4%] and 52 [naïve: 36.6% vs 7.5%; experienced: 21.3% vs 4.8%]; in ELEVATE UC 12, this was observed only for bio/JAKi-naïve patients [naïve: 27.7% vs 16.2%, p = 0.033; experienced: 18.9% vs 13.2%, p = 0.349]. Similar patterns were observed for most efficacy endpoints. Among patients with prior anti-integrin exposure [N = 90], a significantly greater proportion achieved clinical response [54.1% vs 27.6%, p = 0.030], but not clinical remission [9.8% vs 3.4%, p = 0.248], with etrasimod vs placebo.</p><p><strong>Conclusions: </strong>Bio/JAKi-naïve and -experienced patients had clinically meaningful induction and maintenance treatment benefits with etrasimod vs placebo.</p><p><strong>Clinicaltrials.gov: </strong>NCT03945188; NCT03996369.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532610/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141328251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum Metabolites Relate to Mucosal and Transmural Inflammation in Paediatric Crohn Disease.","authors":"Ricardo G Suarez, Namitha Guruprasad, Ganesh Tata, Zhengxiao Zhang, Gili Focht, Daniel McClement, Víctor Manuel Navas-López, Sibylle Koletzko, Anne M Griffiths, Oren Ledder, Lissy de Ridder, David Wishart, Ben Nichols, Konstantinos Gerasimidis, Dan Turner, Eytan Wine","doi":"10.1093/ecco-jcc/jjae085","DOIUrl":"10.1093/ecco-jcc/jjae085","url":null,"abstract":"<p><strong>Background and aims: </strong>We aimed to identify serum metabolites associated with mucosal and transmural inflammation in paediatric Crohn disease [pCD].</p><p><strong>Methods: </strong>In all, 56 pCD patients were included through a pre-planned sub-study of the multicentre, prospective, ImageKids cohort, designed to develop the Paediatric Inflammatory Crohn magnetic resonance enterography [MRE] Index [PICMI]. Children were included throughout their disease course when undergoing ileocolonoscopy and MRE and were followed for 18 months, when MRE was repeated. Serum metabolites were identified using liquid chromatography/mass spectroscopy. Outcomes included: PICMI, the simple endoscopic score [SES], faecal calprotectin [FCP], and C-reactive protein [CRP], to assess transmural, mucosal, and systemic inflammation, respectively. Random forest models were built by outcome. Maximum relevance minimum redundancy [mRMR] feature selection with a j-fold cross-validation scheme identified the best subset of features and hyperparameter settings.</p><p><strong>Results: </strong>Tryptophan and glutarylcarnitine were the top common mRMR metabolites linked to pCD inflammation. Random forest models established that amino acids and amines were among the most influential metabolites for predicting transmural and mucosal inflammation. Predictive models performed well, each with an area under the curve [AUC] > 70%. In addition, serum metabolites linked with pCD inflammation mainly related to perturbations in the citrate cycle [TCA cycle], aminoacyl-tRNA biosynthesis, tryptophan metabolism, butanoate metabolism, and tyrosine metabolism.</p><p><strong>Conclusions: </strong>We extend on recent studies, observing differences in serum metabolites between healthy controls and Crohn disease patients, and suggest various associations of serum metabolites with transmural and mucosal inflammation. These metabolites could improve the understanding of pCD pathogenesis and assessment of disease severity.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532621/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141262226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Seeing Beyond the Surface: Superior Performance of Ultrasound Elastography over Milan Ultrasound Criteria in Distinguishing Fibrosis of Ulcerative Colitis.","authors":"Feng Zhu, Xin Chen, Xueni Qiu, Wenwen Guo, Xuesong Wang, Junying Cao, Jianfeng Gong","doi":"10.1093/ecco-jcc/jjae081","DOIUrl":"10.1093/ecco-jcc/jjae081","url":null,"abstract":"<p><strong>Background: </strong>Colonic fibrosis has important clinical implications in ulcerative colitis [UC]. Ultrasound imaging has emerged as a convenient and reliable tool in diagnosis of inflammatory bowel disease. We aimed to explore the potential use of ultrasound to evaluate UC fibrosis.</p><p><strong>Methods: </strong>Consecutive UC patients who had proctocolectomy from July 2022 to September 2023 were enrolled in the study. Patients underwent bowel ultrasound examination and ultrasound elastography imaging prior to surgery. Milan ultrasound criteria [MUC] were calculated and bowel wall stiffness was determined using two mean strain ratios [MSRs]. Degree of colonic fibrosis and inflammation was measured upon histological analysis. Receiver operating characteristic [ROC] analysis was used to evaluate the performance of ultrasound-derived parameters to predict fibrosis.</p><p><strong>Results: </strong>In all, 56 patients were enrolled with 112 segments included in analysis. The median fibrosis score was 2 [0-4] and the median Geboes score was 5 [0-13] and these two scores were significantly correlated [p < 0.001]. The muscularis mucosa thickness was significantly higher in moderate-severe fibrosis than none-mild fibrosis [p = 0.003] but bowel wall thickness was not [p = 0.082]. The strain ratios [p < 0.001] and MUC [p = 0.010] were significantly higher in involved than non-involved segments. The strain ratios were correlated with fibrosis score [p < 0.001] but not MUC [p = 0.387]. At ROC analysis, mean strain ratio 1 [MSR1] had an area under the curve [AUC] of 0.828 [cutoff value 3.07, 95% CI 0.746-0.893, p < 0.001] to predict moderate-severe fibrosis.</p><p><strong>Conclusion: </strong>Ultrasound elastography imaging could predict the degree of colonic fibrosis in UC. Application of this technique could help disease monitoring and decision making in UC patients.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141201659","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}

{"title":"Rethinking Faecal Microbiota Transplant for Pouchitis.","authors":"Daphne Moutsoglou, Byron P Vaughn","doi":"10.1093/ecco-jcc/jjae100","DOIUrl":"10.1093/ecco-jcc/jjae100","url":null,"abstract":"","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141753672","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}

{"title":"The Effect of Non-pooled Multidonor Faecal Microbiota Transplantation for Inducing Clinical Remission in Patients with Chronic Pouchitis: Results from a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial [MicroPouch].","authors":"Sabrina Just Kousgaard, Frederik Cold, Sofie Ingdam Halkjær, Andreas Munk Petersen, Jens Kjeldsen, Jane Møller Hansen, Sebastian Mølvang Dall, Mads Albertsen, Hans Linde Nielsen, Karina Frahm Kirk, Kirsten Duch, Mads Sønderkær, Ole Thorlacius-Ussing","doi":"10.1093/ecco-jcc/jjae066","DOIUrl":"10.1093/ecco-jcc/jjae066","url":null,"abstract":"<p><strong>Background and aims: </strong>To investigate if treatment with non-pooled, multidonor faecal microbiota transplantation [FMT] for 4 weeks was superior to placebo to induce clinical remission in patients with chronic pouchitis.</p><p><strong>Methods: </strong>The study was a randomised, double-blinded, placebo-controlled study with a 4-week intervention period and 12-month follow-up. Eligible patients with chronic pouchitis were recruited from five Danish hospitals. Participants were randomised to non-pooled, multidonor FMT derived from four faecal donors, or placebo. Treatment was delivered daily by enema for 2 weeks, followed by every second day for 2 weeks. Disease severity was accessed at inclusion and 30-day follow-up, using the Pouchitis Disease Activity Index [PDAI]; PDAI <7 was considered equivalent to clinical remission. Faecal samples from participants and donors were analysed by shotgun metagenomic sequencing.</p><p><strong>Results: </strong>Inclusion was stopped after inclusion of 30 participants who were randomised 1:1 for treatment with FMT or placebo. There was no difference in participants achieving clinical remission between the two groups at 30-day follow-up, relative risk 1.0 (95% CI [0.55; 1.81]). Treatment with FMT resulted in a clinically relevant increase in adverse events compared with placebo, incidence rate ratio 1.67 (95% CI [1.10; 2.52]); no serious adverse events within either group. Faecal microbiota transplantation statistically significantly increased the similarity of participant faecal microbiome to the faecal donor microbiome at 30-day follow-up [p = 0.01], which was not seen after placebo.</p><p><strong>Conclusions: </strong>Non-pooled, multidonor FMT was comparable to placebo in inducing clinical remission in patients with chronic pouchitis, but showed a clinically relevant increase in adverse events compared with placebo. ClincialTrials.gov number, NCT04100291.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140872585","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}

{"title":"Perioperative Enhanced Recovery Concepts Significantly Improve Postoperative Outcome in Patients with Crohn`s Disease.","authors":"Matthias Kelm, Lena Wagner, Anna Widder, Regina Pistorius, Johanna C Wagner, Nicolas Schlegel, Christian Markus, Patrick Meybohm, Christoph-Thomas Germer, Wolfgang Schwenk, Sven Flemming","doi":"10.1093/ecco-jcc/jjae090","DOIUrl":"10.1093/ecco-jcc/jjae090","url":null,"abstract":"<p><strong>Background and aims: </strong>Despite recent advancements in medical and surgical techniques in patients suffering from Crohn`s disease [CD], postoperative morbidity remains relevant due to a long-standing, non-curable disease burden. As demonstrated for oncological patients, perioperative enhanced recovery concepts provide great potential to improve postoperative outcome. However, robust evidence about the effect of perioperative enhanced recovery concepts in the specific cohort of CD patients is lacking.</p><p><strong>Methods: </strong>In a prospective, single-centre study, all patients receiving ileocaecal resection due to CD between 2020 and 2023 were included. A specific, perioperative, enhanced recovery concept [ERC] was implemented and patients were divided into two groups [before and after implementation]. The primary outcome focused on postoperative complications as measured by the Comprehensive Complication Index [CCI], secondary endpoints were severe complications, length of hospital stay, and rates of re-admission.</p><p><strong>Results: </strong>Of 83 patients analysed, 33 patients participated in the enhanced recovery programme [post-ERC]. Whereas patient characteristics were comparable between both groups, ERC resulted in significantly decreased rates of overall and severe postoperative complications [CCI: 21.4 versus 8.4, p = 0.0036; Clavien Dindo > 2: 38% versus 3.1%, p = 0.0002]. Additionally, post-ERC-patients were ready earlier for discharge [5 days versus 6.5 days, p = 0.001] and rates of re-admission were significantly lower [3.1% versus 20%, p = 0.03]. In a multivariate analysis, the recovery concept was identified as independent factor to reduce severe postoperative complications [p = 0.019].</p><p><strong>Conclusion: </strong>A specific, perioperative, enhanced recovery concept significantly improves the postoperative outcome of patients suffering from Crohn`s disease.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141328252","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}

{"title":"Impact of Upadacitinib Induction and Maintenance Therapy on Health-related Quality of Life, Fatigue, and Work Productivity in Patients with Moderately-to-severely Active Crohn's Disease.","authors":"Subrata Ghosh, Brian G Feagan, Rogério Serafim Parra, Susana Lopes, Adam Steinlauf, Yoichi Kakuta, Namita Joshi, Wan-Ju Lee, Ana P Lacerda, Qian Zhou, Si Xuan, Kristina Kligys, Nidhi Shukla, Edouard Louis","doi":"10.1093/ecco-jcc/jjae083","DOIUrl":"10.1093/ecco-jcc/jjae083","url":null,"abstract":"<p><strong>Background and aims: </strong>Quality of life in patients with active Crohn's disease may be significantly reduced. We evaluated the effects of upadacitinib induction and maintenance therapy on fatigue, quality of life, and work productivity in the phase 3 trials U-EXCEL, U-EXCEED, and U-ENDURE.</p><p><strong>Methods: </strong>Clinical responders to upadacitinib 45 mg in U-EXCEL and U-EXCEED induction trials were re-randomised 1:1:1 to upadacitinib 30 mg, 15 mg, or placebo for 52 weeks of maintenance in U-ENDURE. Clinically meaningful improvements in Inflammatory Bowel Disease Questionnaire [IBDQ] response, IBDQ remission, Functional Assessment of Chronic Illness Therapy-Fatigue [FACIT-Fatigue], and Work Productivity and Activity Impairment were evaluated. Percentages of patients achieving clinically meaningful improvements were assessed at induction Weeks 4 and 12 and maintenance Week 52.</p><p><strong>Clinical registration number: </strong>U-EXCEED induction trial [NCT03345836], U-EXCEL induction trial [NCT03345849], U-ENDURE maintenance trial [NCT03345823].</p><p><strong>Results: </strong>Analysis included 1021 and 502 patients assessed at induction and maintenance, respectively. In U-EXCEL, greater improvements [all p ≤ 0.001] in IBDQ response [71.0% vs 50.2%], IBDQ remission [44.2% vs 23.7%], and FACIT-Fatigue [42.0% vs 27.0%] were observed in upadacitinib-treated patients versus placebo at Week 4. Improvements in IBDQ response, IBDQ remission, and FACIT-Fatigue were similar or greater at Week 12. Clinically meaningful improvement in overall work impairment [52.1% vs 38.1%, p ≤ 0.05] was demonstrated at Week 12. Similar results were observed in U-EXCEED. Improvements were sustained through 52 weeks of upadacitinib maintenance treatment.</p><p><strong>Conclusions: </strong>In patients with active Crohn's disease, upadacitinib treatment relative to placebo significantly improved fatigue, quality of life, and work productivity as early as Week 4. These effects were sustained through 52 weeks of maintenance.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532615/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141249141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme.","authors":"Silvio Danese, Axel Dignass, Katsuyoshi Matsuoka, Marc Ferrante, Millie Long, Isabel Redondo, Richard Moses, Sebastian Maier, Theresa Hunter Gibble, Nathan Morris, Catherine Milch, Maria T Abreu","doi":"10.1093/ecco-jcc/jjae088","DOIUrl":"10.1093/ecco-jcc/jjae088","url":null,"abstract":"<p><strong>Background and aims: </strong>Ulcerative colitis [UC], a chronic inflammatory bowel disease, may manifest with symptoms of increased stool frequency [SF], rectal bleeding [RB], bowel urgency [BU], abdominal pain [AP], and fatigue. Mirikizumab, an anti-IL-23p19 antibody, demonstrated efficacy and safety in patients with moderately to severely active UC in the LUCENT Phase 3 trials. We evaluated mirikizumab's efficacy in achieving symptom control and time to symptom improvement during induction, maintenance of sustained symptom control, 'comprehensive symptom control', defined according to a combination of individual patient-reported outcomes, and prognostic baseline indicators of early symptomatic remission at Week 4.</p><p><strong>Methods: </strong>The results of LUCENT-1/-2 have previously been reported. Treatment differences for symptomatic endpoints were compared over 52 weeks versus placebo [PBO] and comprehensive symptomatic endpoints at 12 and 52 weeks of continuous treatment. Subgroup analyses were conducted for prior biologic or tofacitinib treatment failure. Prognostic analyses were run using regression analysis.</p><p><strong>Results: </strong>By Week [W] 2, mirikizumab-treated patients achieved greater reductions in SF, RB, BU, and fatigue versus PBO. At W4, there was a higher rate of AP improvement. At W12, a greater proportion of mirikizumab-treated patients achieved symptomatic remission, RB remission, SF remission, and BU remission/clinically meaningful improvement. Mirikizumab-treated patients sustained symptom control versus placebo patients in maintenance until W52. This treatment effect was shown in patients regardless of prior biologic or tofacitinib failure. Additionally, mirikizumab achieved comprehensive symptom control versus PBO at W12 and W52.</p><p><strong>Conclusions: </strong>Mirikizumab demonstrated efficacy in achieving and sustaining symptom control and comprehensive symptom control over 52 weeks [NCT03518086; NCT03524092].</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532612/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141312637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gut Microbial Species and Endotypes Associate with Remission in Ulcerative Colitis Patients Treated with Anti-TNF or Anti-integrin Therapy.","authors":"Fiona B Tamburini, Anupriya Tripathi, Maxwell P Gold, Julianne C Yang, Tommaso Biancalani, Jacqueline M McBride, Mary E Keir, Gardenia Study Group","doi":"10.1093/ecco-jcc/jjae084","DOIUrl":"10.1093/ecco-jcc/jjae084","url":null,"abstract":"<p><strong>Background and aims: </strong>The gut microbiota contributes to aberrant inflammation in inflammatory bowel disease, but the bacterial factors causing or exacerbating inflammation are not fully understood. Further, the predictive or prognostic value of gut microbial biomarkers for remission in response to biologic therapy is unclear.</p><p><strong>Methods: </strong>We perform whole metagenomic sequencing of 550 stool samples from 287 ulcerative colitis patients from a large, phase 3, head-to-head study of infliximab and etrolizumab.</p><p><strong>Results: </strong>We identify several bacterial species in baseline and/or post-treatment samples that associate with clinical remission. These include previously described associations [Faecalibacterium prausnitzii_F] as well as new associations with remission to biologic therapy [Flavonifractor plautii]. We build multivariate models and find that gut microbial species are better predictors for remission than clinical variables alone. Finally, we describe patient groups that differ in microbiome composition and remission rate after induction therapy, suggesting the potential utility of microbiome-based endotyping.</p><p><strong>Conclusions: </strong>In this large study of ulcerative colitis patients, we show that few individual species associate strongly with clinical remission, but multivariate models including microbiome can predict clinical remission and have better predictive power compared with clinical data alone.</p>","PeriodicalId":94074,"journal":{"name":"Journal of Crohn's & colitis","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141249140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}