bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness and safety of obeticholic acid in a Southern European multicentre cohort of patients with primary biliary cholangitis and suboptimal response to ursodeoxycholic acid
Authors: Gomez Elena , Garcia Buey Luisa , Molina Esther , Casado Marta , Conde Isabel , Berenguer Marina , Jorquera Francisco , Simón Miguel‐Angel , Olveira Antonio , Hernández‐Guerra Manuel , Mesquita Monica , Presa Jose , Costa‐Moreira Pedro , Macedo Guilherme , Arenas Juan I. , Manuel Sousa Jose , Ampuero Javier , Morillas Rosa M. , Santos Arsenio , De Carvalho Armando , Uriz Javier , Carrión Jose A. , Luisa Gutiérrez Maria , Pérez‐Fernández Elia , Fernández‐Rodríguez Conrado M. ,   the IBER‐PBC leading Cooperative Group
Published: September 2023

SummaryBackgroundObeticholic acid (OCA) was recently approved as the only on‐label alternative for patients with primary biliary cholangitis (PBC) with intolerance or suboptimal response to ursodeoxycholic acid (UDCA). However, few data are available outside clinical trials.AimTo assess the effectiveness and safety of OCA in a real‐world cohort of patients with non‐effective UDCA therapy.MethodsOpen‐label, prospective, real‐world, multicentre study, enrolling consecutive patients who did not meet Paris II criteria, from 18 institutions in Spain and Portugal. Effectiveness was assessed by the changes in GLOBE and UK‐PBC scores from baseline. POISE and Paris II criteria were evaluated after 12 months of OCA . Liver fibrosis was evaluated by FIB‐4 and AST to platelet ratio index (APRI).ResultsOne hundred and twenty patients were eligible, median time since PBC diagnosis 9.3 (4.0‐13.8) years, 21.7% had cirrhosis, and 26.7% received had previous or concomitant treatment with fibrates. Seventy‐eight patients completed at least 1 year of OCA. The Globe‐PBC score decreased to 0.17 (95% CI 0.05 to 0.28; P = 0.005) and the UK‐PBC score decreased to 0.81 (95% CI −0.19 to 1.80; P = 0.11). There was a significant decrease in alkaline phosphatase of 81.3 U/L (95% CI 42.5 to 120; P < 0.001), ALT 22.1 U/L (95% CI 10.4 to 33.8; P < 0.001) and bilirubin 0.12 mg/dL (95% CI 0 to 0.24; P = 0.044). FIB‐4 and APRI remained stable. According to the POISE criteria, 29.5% (23 out of 78) achieved response. The adverse events rate was 35%; 11.67% discontinued (8.3% due to pruritus).ConclusionsThis study supports data from phase III trials with significant improvement of PBC‐Globe continuous prognostic marker score among OCA‐treated patients with good tolerability.
Letter: rates and determinants of significant liver inflammation in chronic hepatitis B virus‐infected patients with low ALT levels in the absence of significant fibrosis—authors' reply
Authors: Sonneveld Milan J. , Brouwer Willem P. , de Man Robert A. , Janssen Harry L. A. ,   for the SONIC‐B Study Group
Published: September 2023

LINKED CONTENT
This article is linked to Sonneveld et al and Huang papers. To view these articles, visit https://doi.org/10.1111/apt.16067 and https://doi.org/10.1111/apt.16164
Derivation and validation of a novel method to subgroup patients with functional dyspepsia: beyond upper gastrointestinal symptoms
Authors: Barberio Brigida , Pinto‐Sanchez Maria Ines , Bercik Premysl , Sood Ruchit , Savarino Edoardo V. , Moayyedi Paul , Black Christopher J. , Ford Alexander C. 
Published: September 2023

SummaryBackgroundConventionally, patients with functional dyspepsia are subgrouped based on upper gastrointestinal symptoms, according to the Rome criteria. However, psychological co‐morbidity and extraintestinal symptoms are also relevant to functional gastrointestinal disorders.AimTo investigate whether it is possible to subgroup people with functional dyspepsia using factors beyond upper gastrointestinal symptoms.MethodsWe collected demographic, symptom and psychological health data from adult subjects meeting the Rome III criteria for functional dyspepsia in two secondary care cross‐sectional surveys in Canada and the UK. We performed latent class analysis, a method of model‐based clustering, to identify specific subgroups (clusters). For each cluster, we drew a radar plot, and compared these by visual inspection, describing cluster characteristics.ResultsIn total, 400 individuals met Rome III criteria for functional dyspepsia in the Canadian cohort, and 262 the UK cohort. A four‐cluster model was the optimum solution and the characteristics of the clusters were almost identical between the two cohorts. The clusters were defined by a pattern of gastrointestinal symptoms and were further differentiated by the extent of extraintestinal and psychological co‐morbidity. Cluster 1 (mean age 46.7 years, 66.7% female) consisted of epigastric pain and nausea with high psychological burden, cluster 2 (mean age 41.5 years, 77.7% female) high overall gastrointestinal symptom severity with high psychological burden, cluster 3 (45.8 years, 67.2% female) oesophageal symptoms and early satiety with low psychological burden, and cluster 4 (mean age 40.4 years, 71.5% female) postprandial fullness with low psychological burden. We validated the model derived using the Canadian study population externally by applying it to the UK dataset. We demonstrated reproducibility; it would perform similarly when applied to a different dataset.ConclusionsLatent class analysis identified four distinct functional dyspepsia subgroups characterised by varying degrees of gastrointestinal symptoms, extraintestinal symptoms and psychological co‐morbidity. Further research is needed to assess whether they might be used to direct treatment.
Editorial: a pipe dream fulfilled? A therapeutic option for fatigue in IBD
Authors: LeBlanc Jean‐Frédéric , Hart Ailsa L. 
Published: September 2023

LINKED CONTENT
This article is linked to Bager et al papers. To view these articles, visit https://doi.org/10.1111/apt.16166 and https://doi.org/10.1111/apt.16209
Editorial: can serum triiodothyronine‐to‐thyroxine (T3/T4) ratio predict safety and efficacy of biologic treatment in IBD?
Authors: Carbery Isabel , Selinger Christian P. 
Published: September 2023

LINKED CONTENT
This article is linked to Bertani et al papers. To view these articles, visit https://doi.org/10.1111/apt.16167 and https://doi.org/10.1111/apt.16213
Editorial: fatigue—difficult to assess and difficult to treat. Authors' reply
Authors: Schreiner Philipp , von Känel Roland , Misselwitz Benjamin 
Published: September 2023

LINKED CONTENT
This article is linked to Schreiner et al and Murray papers. To view these articles, visit https://doi.org/10.1111/apt.16145 and https://doi.org/10.1111/apt.16178
Safety of ustekinumab or vedolizumab in pregnant inflammatory bowel disease patients: a multicentre cohort study
Authors: Wils Pauline , Seksik Philippe , Stefanescu Carmen , Nancey Stephane , Allez Matthieu , Pineton de Chambrun Guillaume , Altwegg Romain , Gilletta Cyrielle , Vuitton Lucine , Viennot Stéphanie , Serrero Mélanie , Fumery Mathurin , Savoye Guillaume , Collins Michael , Goutorbe Felix , Brixi Hedia , Bouguen Guillaume , Tavernier Noémie , Boualit Medina , Amiot Aurélien , Abitbol Vered , Laharie David , Pariente Benjamin ,   the PREGNANCY‐GETAID study group
Published: September 2023

SummaryBackgroundThe prevalence of inflammatory bowel diseases (IBD) is high in women of childbearing age. Achieving clinical remission from conception to delivery using current medications is a major issue in IBD.AimsTo assess maternal and neonatal complications and management of vedolizumab or ustekinumab) in pregnant women with IBD receiving these agents.MethodsWe performed a retrospective cohort study among GETAID centres including women with IBD who received ustekinumab or vedolizumab during pregnancy or within the 2 months before conception and compared outcomes to women exposed to anti‐TNF treatment during pregnancy.ResultsSeventy‐three pregnancies in 68 women with IBD were analysed: 29 on ustekinumab resulting in 26 (90%) live births, two (7%) spontaneous abortions and one (3%) elective termination; 44 on vedolizumab resulting in 38 (86%) live births, five (11%) spontaneous abortions and one (3%) medical interruption. The control group included 88 pregnancies exposed to anti‐TNF in 76 women with IBD. The median age at conception, the proportion of women who smoked or in clinical activity at conception was comparable between groups. Only the proportion of patients exposed to >2 anti‐TNF agents was significantly increased among the ustekinumab and vedolizumab groups compared to control group (22% and 10% vs 3%, P < 0.005). Rates of prematurity, spontaneous abortion, congenital malformations and maternal complications were comparable between groups.ConclusionWe report 73 pregnancies in patients receiving vedolizumab or ustekinumab without a negative signal on maternal or neonatal outcomes. Further prospective studies are needed on the outcomes of pregnancies with new biologic drugs.
Drug survival of anti‐TNF agents compared with vedolizumab as a second‐line biological treatment in inflammatory bowel disease: results from nationwide Swedish registers
Authors: Rundquist Sara , Sachs Michael C. , Eriksson Carl , Olén Ola , Montgomery Scott , Halfvarson Jonas ,   The SWIBREG Study Group
Published: September 2023

SummaryBackgroundComparisons of second‐line anti‐tumour necrosis factor (TNF) agents and vedolizumab are sparse.AimTo evaluate the effectiveness of anti‐TNF agents compared to vedolizumab as second‐line biologics in inflammatory bowel disease (IBD).MethodsA propensity score‐matched cohort was created using Swedish nationwide registers. Patients with Crohn's disease or ulcerative colitis, exposed to first‐line anti‐TNF treatment, who initiated a second anti‐TNF agent or vedolizumab in 2014‐2016 (N = 1363) were included. The primary outcome was drug survival at 12 months. Secondarily, we assessed survival without IBD‐related hospitalisation, IBD‐related surgery, antibiotics, or hospitalisation because of infection, and also corticosteroid exposure.ResultsAfter 1:1 propensity score matching, 400 patients (Crohn's disease, N = 198; ulcerative colitis, N = 202) remained. For Crohn's disease, drug survival was 73% in the vedolizumab group vs 74% in the anti‐TNF group (difference: 1 percentage point; 95% confidence interval [CI]:‐11‐13; P = 0.87). Survival without IBD‐related hospitalisation (82% vs 88%), surgery (82% vs 89%), antibiotics (65% vs 71%), hospitalisation due to infection (95% vs 88%) and corticosteroids (58% vs 48%) were not statistically significantly different between groups. For ulcerative colitis, drug survival was 69% in the vedolizumab group vs 62% in the anti‐TNF group (difference: −7 percentage points; 95% CI: −20 to 6; P = 0.30). Vedolizumab‐treated patients had lower survival without IBD‐related hospitalisation (82% vs 93%, P = 0.02). Survival without colectomy (93% vs 97%), antibiotics (81% vs 70%), hospitalisation due to infection (92% vs 92%) and corticosteroids (58% vs 48%) were not statistically significantly different.ConclusionsBased on Swedish clinical practice, the effectiveness and safety of second‐line anti‐TNF and vedolizumab at 12 months appeared largely similar.
Letter: PPIs in EoE—More questions than answers
Authors: Miehlke Stephan , von Arnim Ulrike , Attwood Stephen 
Published: September 2023

LINKED CONTENT
This article is linked to Laserna‐Mendieta et al and Lucendo et al papers. To view these articles, visit https://doi.org/10.1111/apt.15957 and https://doi.org/10.1111/apt.16216
Letter: no‐biopsy pathway for diagnosing adult coeliac disease—authors' reply
Authors: Kurppa Kalle , Kivelä Laura , Kaukinen Katri 
Published: September 2023

LINKED CONTENT
This article is linked to Fuchs et al and Paul et al papers. To view these articles, visit https://doi.org/10.1111/apt.15109 and https://doi.org/10.1111/apt.16133
Editorial: “Stardust gastric mucosa” – A novel and consistent marker of vonoprazan safety during follow‐up?
Authors: Luu Maxime , Ben Ghezala Ines , Bardou Marc 
Published: September 2023

LINKED CONTENT
This article is linked to Yoshizaki et al paper. To view these article, visit https://doi.org/10.1111/apt.16151
Microbiome as a potential diagnostic and predictive biomarker in severe alcoholic hepatitis
Authors: Kim Soon Sun , Eun Jung Woo , Cho Hyo Jung , Song Do Seon , Kim Chang Wook , Kim Young Seok , Lee Sung Won , Kim Yoon‐Keun , Yang Jinho , Choi Jinhee , Yim Hyung Joon , Cheong Jae Youn 
Published: September 2023

SummaryBackgroundSevere alcoholic hepatitis (AH) is the most aggressive form of alcohol‐related liver disease with high mortality. The microbiome is an emerging therapeutic target in alcohol‐related liver disease.AimsTo investigate the microbiome composition in patients with severe AH, and to determine microbiome recovery after rifaximin treatment in gut bacteria and bacteria derived‐extracellular vesicles.MethodsWe enrolled 24 patients with severe AH and 24 healthy controls. Additional faecal samples were collected after 4 weeks in 8 patients with severe AH who completed rifaximin treatment. Treatment response was defined based on Lille score model after 7 days of treatment. Metagenomic profiling was performed using 16S ribosomal RNA amplicon sequencing.ResultsFaecal microbiomes of patients with severe AH had lower alpha diversity and higher beta diversity than those of healthy controls in both gut bacteria and extracellular vesicles. Bacilli, Lactobacillales and Veillonella were significantly increased in the gut bacteria of patients with severe AH, and Veillonella, Veillonella parvula group and Lactobacillales were significantly increased in the extracellular vesicles of patients with severe AH. Eubacterium_g23, Oscillibacter and Clostridiales decreased in the gut bacteria of patients with severe AH, and Eubacterium_g23, Oscillibacter and Christensenellaceae decreased in the extracellular vesicles of patients with severe AH. After rifaximin treatment, 17 taxa in the gut bacteria and 23 taxa in extracellular vesicles were significantly restored in patients with severe AH. In common, Veillonella and Veillonella parvula group increased in patients with severe AH and decreased after rifaximin treatment, and Prevotella and Prevotellaceae decreased in patients with severe AH and increased after rifaximin treatment. Treatment non‐responders showed a significantly lower abundance of Prevotella at baseline than did treatment responders.ConclusionDysbiosis was confirmed in severe AH but was alleviated by rifaximin treatment. Taxa associated with severe AH can be candidate biomarkers or therapeutic targets.
Fructan‐sensitive children with irritable bowel syndrome have distinct gut microbiome signatures
Authors: Chumpitazi Bruno P. , Hoffman Kristi L. , Smith Daniel P. , McMeans Ann R. , Musaad Salma , Versalovic James , Petrosino Joseph F. , Shulman Robert J. 
Published: September 2023

SummaryBackgroundDietary fructans may worsen gastrointestinal symptoms in children with irritable bowel syndrome (IBS).AimTo determine whether gut microbiome composition and function are associated with childhood IBS fructan‐induced symptoms.MethodsFaecal samples were collected from 38 children aged 7‐17 years with paediatric Rome III IBS, who previously completied a double‐blind, randomised, placebo‐controlled crossover (fructan vs maltodextrin) trial. Fructan sensitivity was defined as an increase of ≥30% in abdominal pain frequency during the fructan diet. Gut microbial composition was determined via 16Sv4 rDNA sequencing. LEfSe evaluated taxonomic composition differences. Tax4Fun2 predicted microbial fructan metabolic pathways.ResultsAt baseline, 17 fructan‐sensitive (vs 21 fructan‐tolerant) subjects had lower alpha diversity (q < 0.05) and were enriched in the genus Holdermania. In contrast, fructan‐tolerant subjects were enriched in 14 genera from the class Clostridia. During the fructan diet, fructan‐sensitive (vs tolerant) subjects were enriched in both Agathobacter (P = 0.02) and Cyanobacteria (P = 0.0001). In contrast, fructan‐tolerant subjects were enriched in three genera from the Clostridia class. Comparing the fructan vs maltodextrin diet, fructan‐sensitive subjects had a significantly increased relative abundance of Bifidobacterium (P = 0.02) while fructan‐tolerant subjects had increased Anaerostipes (P = 0.03) during the fructan diet. Only fructan‐sensitive subjects had a trend towards increased predicted β‐fructofuranosidase during the fructan vs maltodextrin diet.ConclusionsFructan‐sensitive children with IBS have distinct gut microbiome signatures. These microbiome signatures differ both at baseline and in response to a fructan challenge.
Editorial: Penetration of food protein through the oesophageal mucosa—is this where EoE starts?
Authors: Uchida Amiko M. , Dougan Michael 
Published: September 2023

LINKED CONTENTThis article is linked to Ravi et al and Ravi & Katzka papers. To view these articles, visit https://doi.org/10.1111/apt.16180 and https://doi.org/10.1111/apt.16223
Editorial: a pipe dream fulfilled? A therapeutic option for fatigue in IBD. Authors' reply
Authors: Bager Palle , Hvas Christian Lodberg , Rud Charlotte Lock , Dahlerup Jens Frederik 
Published: September 2023

LINKED CONTENT
This article is linked to Bager et al and LeBlanc & Hart papers. To view these articles, visit https://doi.org/10.1111/apt.16166 and https://doi.org/10.1111/apt.16185
Letter: propensity score—handle with care. Authors’ reply
Authors: Townsend Tristan , Subramanian Sreedhar 
Published: September 2023

LINKED CONTENT
This article is linked to Townsend et al and Macaluso & Orlando papers. To view these articles, visit https://doi.org/10.1111/apt.16057 and https://doi.org/10.1111/apt.16179
Editorial: can serum triiodothyronine‐to‐thyroxine (T3/T4) ratio predict safety and efficacy of biologic treatment in IBD? Authors' reply
Authors: Bertani Lorenzo , Pugliese Daniela , Tricò Domenico , Costa Francesco , Blandizzi Corrado 
Published: September 2023

LINKED CONTENT
This article is linked to Bertani et al and Carbery & Selinger papers. To view these articles, visit https://doi.org/10.1111/apt.16167 and https://doi.org/10.1111/apt.16286
Editorial: missed opportunities to detect colorectal cancer in inflammatory bowel disease—getting to the root. Authors’ reply
Authors: Chee Desmond , Kennedy Nicholas A. , Goodhand James R. , Ahmad Tariq 
Published: September 2023

LINKED CONTENT
This article is linked to Gordon et al and Mahmoud & Itzkowitz papers. To view these articles, visit https://doi.org/10.1111/apt.16155 and https://doi.org/10.1111/apt.16175
Letter: PPI in EoE – more questions than answers. Authors' reply
Authors: Lucendo Alfredo J. , Arias Ángel , Laserna‐Mendieta Emilio J. 
Published: September 2023

LINKED CONTENT
This article is linked to Laserna‐Mendieta et al and Miehlke et al papers. To view these articles, visit https://doi.org/10.1111/apt.15957 and https://doi.org/10.1111/apt.16194
Systematic review with meta‐analysis: safety and tolerability of immune checkpoint inhibitors in patients with pre‐existing inflammatory bowel diseases
Authors: Meserve Joseph , Facciorusso Antonio , Holmer Ariela K. , Annese Vito , Sandborn William J. , Singh Siddharth 
Published: September 2023

SummaryBackgroundImmune checkpoint inhibitors may variably impact patients with pre‐existing autoimmune diseases.AimsTo evaluate the risks and outcomes of adverse events in patients with pre‐existing inflammatory bowel diseases treated with immune checkpoint inhibitors.MethodsThrough a systematic literature review up until July 31, 2020, we identified 12 studies reporting the impact of immune checkpoint inhibitors in 193 patients with inflammatory bowel disease. Outcomes of interest were relapse of inflammatory bowel disease, need for corticosteroids and/or biologics to manage inflammatory bowel disease relapse, and discontinuation of immune checkpoint inhibitors. We calculated pooled rates (with 95% confidence intervals [CI]) using random effects meta‐analysis, and examined risk factors associated with adverse outcomes through qualitative synthesis of individual studies.ResultsOn meta‐analysis, 40% patients (95% CI, 26%‐55%) experienced relapse of inflammatory bowel disease with immune checkpoint inhibitors. Among patients who experienced relapse, 76% (95% CI, 65%‐85%) required corticosteroids, and 37% (95% CI, 22%‐53%) required biologic therapy. Overall, 35% patients (95% CI, 17%‐57%) with inflammatory bowel disease discontinued immune checkpoint inhibitors. Gastrointestinal perforation and abdominal surgery due to immune checkpoint inhibitor complications occurred in <5% patients. In a large study, inhibitors of cytotoxic T‐lymphocyte antigen‐4 (CTLA‐4) were associated with a higher risk of relapse than programmed cell death 1 (PD‐1) and programmed death ligand 1 (PD‐L1) inhibitors.ConclusionsApproximately 40% of patients with pre‐existing inflammatory bowel diseases experience relapse with immune checkpoint inhibitors, with most relapsing patients requiring corticosteroids and one‐third requiring biologics. CTLA‐4 inhibitors may be associated with higher risk of relapse.
Editorial: microRNAs for the diagnosis of fatty liver disease in the population—are we inching closer towards the target?
Authors: Ma Ann T. , Ginès Pere 
Published: September 2023

LINKED CONTENT
This article is linked to Zhang et al and Zhang & Ghanbari papers. To view these articles, visit https://doi.org/10.1111/apt.16177 and https://doi.org/10.1111/apt.16234
Editorial: penetration of food protein through the oesophageal mucosa ‐ is this where EoE starts? Authors' reply
Authors: Ravi Anupama , Katzka David A. 
Published: September 2023

LINKED CONTENTThis article is linked to Ravi et al and Uchida & Dougan papers. To view these articles, visit https://doi.org/10.1111/apt.16180 and https://doi.org/10.1111/apt.16205
Editorial: Biomarkers in HBV and prediction of treatment response – authors’ reply
Authors: Lim Seng Gee ,   the authors
Published: September 2023

LINKED CONTENT
This article is linked to Lim et al and Ridruejo papers. To view these articles, visit https://doi.org/10.1111/apt.16149 and https://doi.org/10.1111/apt.16171
Editorial: vedolizumab in inflammatory bowel diseases—less is more? Authors’ reply
Authors: Danese Silvio , Subramaniam Kavitha , Van Zyl Jan , Adsul Shashi 
Published: September 2023

LINKED CONTENTThis article is linked to Danese et al and Townsend & Subramanian papers. To view these articles, visithttps://doi.org/10.1111/apt.16160andhttps://doi.org/10.1111/apt.16191
Editorial: keep calm and carry on—managing non‐TNF antagonist biologics in pregnancy—authors' reply
Authors: Wils Pauline , Pariente Benjamin 
Published: September 2023

LINKED CONTENTThis article is linked to Wils et al and Seow & Ma papers. To view these articles, visit https://doi.org/10.1111/apt.16192 and https://doi.org/10.1111/apt.16207
Editorial: HBV cure—the quest for biomarkers to predict off‐treatment sustained response. Authors' reply
Authors: Brakenhoff Sylvia M. , de Man Robert A. , de Knegt Robert J. , Janssen Harry L. A. , Sonneveld Milan J. 
Published: September 2023

LINKED CONTENT
This article is linked to Brakenhoff et al and Thibault & Asselah papers. To view these articles, visit https://doi.org/10.1111/apt.16172 and https://doi.org/10.1111/apt.16214
Editorial: microRNAs for the diagnosis of fatty liver disease in the population—are we inching closer towards the target? Authors' reply
Authors: Zhang Xiaofang , Ghanbari Mohsen 
Published: September 2023

LINKED CONTENT
This article is linked to Zhang et al and Ma & Ginès papers. To view these articles, visit https://doi.org/10.1111/apt.16177 and https://doi.org/10.1111/apt.16219