{"title":"Letter: Beyond Feasibility: The Need for Longer Duration and Composite NIT Endpoints in Biopsy-Free MASH Trials.","authors":"Wenbin Dai,Guochun Zhang","doi":"10.1111/apt.70701","DOIUrl":"https://doi.org/10.1111/apt.70701","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"50 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147751359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
A B Fons,V E R Asscher,S P Mooijaart,P W J Maljaars
{"title":"Editorial: Optimal Treatment for Older Patients With Inflammatory Bowel Disease: How to Detect and Manage Frailty? Authors' Reply.","authors":"A B Fons,V E R Asscher,S P Mooijaart,P W J Maljaars","doi":"10.1111/apt.70660","DOIUrl":"https://doi.org/10.1111/apt.70660","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"1 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147739035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Letter: Early Inflammatory Benefit Is Not Yet Equivalent to Durable Surgical Advantage After Colectomy in Colonic Crohn's Disease.","authors":"Jiacheng Li","doi":"10.1111/apt.70700","DOIUrl":"https://doi.org/10.1111/apt.70700","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"148 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147739034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elyke H. Visser, Martijn. A. Oude Voshaar, Reinier C. A. van Linschoten, Alexander G. L. Bodelier, Claire Fitzpatrick, Vincent de Jonge, Hestia Vermeulen, K. Evelyne Verweij, Sanne van der Wiel, Daniëlle van der Horst, C. Janneke van der Woude, R. L. West, D. van Noord
{"title":"A Care Pathway for the Treatment of IBD Reduces Healthcare Costs and Is Cost‐Effective: Results of the Multicentre IBD Value Study","authors":"Elyke H. Visser, Martijn. A. Oude Voshaar, Reinier C. A. van Linschoten, Alexander G. L. Bodelier, Claire Fitzpatrick, Vincent de Jonge, Hestia Vermeulen, K. Evelyne Verweij, Sanne van der Wiel, Daniëlle van der Horst, C. Janneke van der Woude, R. L. West, D. van Noord","doi":"10.1111/apt.70690","DOIUrl":"https://doi.org/10.1111/apt.70690","url":null,"abstract":"Background An advanced therapy care pathway (ACP) for the treatment of patients with IBD can reduce practice variation and improve outcomes. Aims This study aimed to estimate the effect of the ACP on costs and quality of life, and to assess the cost‐effectiveness of the ACP. Methods A cost‐utility and cost‐effectiveness analysis was conducted from a societal perspective. The ACP was implemented in six hospitals, and two hospitals in the same region served as controls. Costs and quality of life were assessed during a baseline period (December 2020–December 2021) and an intervention period after implementing the ACP (March 2022–March 2023). Quality‐adjusted life years (QALYs) were derived from the EQ‐5D‐5L; disease control from the IBD‐Control questionnaire. A difference‐in‐differences (DiD) analysis was conducted, and the net monetary benefit and incremental cost‐effectiveness ratio (ICER) were calculated. Results In total, 1,173 patients were included (intervention <jats:italic>n</jats:italic> = 841, control <jats:italic>n</jats:italic> = 332). Baseline costs per patient were €23,259.96 in the intervention hospitals and €22,837.93 in the control hospitals. During the intervention period, costs decreased to €20,959.76 in intervention hospitals. This reduction was not observed in control hospitals (€22,191.21). The DiD‐analysis showed cost savings of −€1933.69; QALYs (0.001) and disease control (0.15) did not change. The ICER indicated cost savings without compromising quality of life or disease control. Conclusions The implementation of an ACP for the treatment of patients with IBD reduces costs, maintains quality of life and disease control, and is cost‐effective. These results emphasise that the implementation of care pathways in current practices should be considered. Trial registration number: NL‐OMON21751. Website: Value‐based healthcare for Inflammatory Bowel Disease: Improving (cost‐) effectiveness.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"24 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147733718","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Suzanne Sharpton,Luis Antonio Díaz,Kay Pepin,Maral Amangurbanova,Egbert Madamba,Ricki Bettencourt,Seema Singh,Mark Valasek,Mary Dalupang,Kaleb Tesfai,Michael S Middleton,Cynthia Behling,Winston Dunn,Atsushi Nakajima,Kento Imajo,Yuji Ogawa,Cyrielle Caussy,Dina Halegoua-DeMarzio,Arpan Mohanty,Daniel Q Huang,Michael Fuchs,Bilal Hameed,Jonathan G Stine,Maya Balakrishnan,Meagan Gray,Manuel Rodriguez,Andre DeLeon,Rohit Puskoor,Raj Vuppalanchi,Jaideep Behari,Lars Hansen,Cynthia Miller,Valentina Medici,Souvik Sarkar,Jerome Boursier,Monica Tincopa,Veeral Ajmera,Lisa Richards,Claude B Sirlin,Richard L Ehman,Rohit Loomba,
{"title":"Global Longitudinal Assessment of MASLD Using Magnetic Resonance Elastography (GOLDMINE): A Multi-Center, International Prospective Cohort Study of Imaging Biomarkers in MASLD Clinical Outcomes.","authors":"Suzanne Sharpton,Luis Antonio Díaz,Kay Pepin,Maral Amangurbanova,Egbert Madamba,Ricki Bettencourt,Seema Singh,Mark Valasek,Mary Dalupang,Kaleb Tesfai,Michael S Middleton,Cynthia Behling,Winston Dunn,Atsushi Nakajima,Kento Imajo,Yuji Ogawa,Cyrielle Caussy,Dina Halegoua-DeMarzio,Arpan Mohanty,Daniel Q Huang,Michael Fuchs,Bilal Hameed,Jonathan G Stine,Maya Balakrishnan,Meagan Gray,Manuel Rodriguez,Andre DeLeon,Rohit Puskoor,Raj Vuppalanchi,Jaideep Behari,Lars Hansen,Cynthia Miller,Valentina Medici,Souvik Sarkar,Jerome Boursier,Monica Tincopa,Veeral Ajmera,Lisa Richards,Claude B Sirlin,Richard L Ehman,Rohit Loomba, ","doi":"10.1111/apt.70696","DOIUrl":"https://doi.org/10.1111/apt.70696","url":null,"abstract":"BACKGROUNDMetabolic dysfunction-associated steatotic liver disease (MASLD) exhibits marked heterogeneity in fibrosis progression and liver-related outcomes. Liver biopsy is not feasible for longitudinal risk stratification at scale, creating a need for validated non-invasive biomarkers, particularly imaging biomarkers, that can predict clinically meaningful disease progression and liver-related outcomes.AIMSTo describe the design and rationale of the GOLDMINE study, established to determine whether non-invasive imaging biomarkers predict MASLD progression and liver-related clinical outcomes.METHODSGOLDMINE is an investigator-initiated, multi-centre, international longitudinal cohort enrolling up to 1000 adults with either biopsy-proven MASLD or MASLD cirrhosis across the full fibrosis spectrum. Participants are recruited from 15 sites in the US and 4 international sites (Japan, Singapore and France). At baseline, participants undergo clinical phenotyping, vibration-controlled transient elastography, and advanced magnetic resonance imaging (MRI), including proton-density-fat-fraction and magnetic resonance elastography (MRE). MRI (and biospecimen banking) is repeated at 2-year intervals (years 2 and 4), with annual follow-up visits for up to 10 years. Baseline liver histology is centrally processed, digitized and reviewed by a single expert hepatopathologist; all MRI/MREs are centrally interpreted.RESULTSThe prespecified clinical outcomes include progression to cirrhosis, clinically significant portal hypertension, major adverse liver-related outcomes (ascites, hepatic encephalopathy, portal hypertensive bleeding, liver transplantation/qualification), hepatocellular carcinoma, major adverse cardiovascular events, and all-cause mortality, with independent central adjudication of all events.CONCLUSIONSGOLDMINE establishes a rigorously phenotyped MASLD cohort integrating centralized histology, advanced MRI-based biomarkers, longitudinal biobanking, and adjudicated outcomes, providing a platform to validate imaging and blood-based prognostic biomarkers in MASLD.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"22 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147731346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rohit Loomba,Enrique de-Madaria,Elham Afghani,Vikesh K Singh,Nicholas J Leeper
{"title":"Editorial: Gene Silencing Therapy for a New Era of Pancreatitis Prevention. Authors' Reply.","authors":"Rohit Loomba,Enrique de-Madaria,Elham Afghani,Vikesh K Singh,Nicholas J Leeper","doi":"10.1111/apt.70692","DOIUrl":"https://doi.org/10.1111/apt.70692","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"29 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147731350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Marlene Hintersteininger, Michael Schwarz, Philipp Schwabl, Lukas Hartl, Lorenz Balcar, Benedikt Silvester Hofer, Georg Kramer, Christian Sebesta, Paul Thöne, Patrik Attalla, Michael Gschwantler, Michael Trauner, Mattias Mandorfer, Thomas Reiberger, Mathias Jachs
{"title":"Correlation of Bile Acid Dynamics to Bulevirtide Response and Disease Severity in Patients With Hepatitis D","authors":"Marlene Hintersteininger, Michael Schwarz, Philipp Schwabl, Lukas Hartl, Lorenz Balcar, Benedikt Silvester Hofer, Georg Kramer, Christian Sebesta, Paul Thöne, Patrik Attalla, Michael Gschwantler, Michael Trauner, Mattias Mandorfer, Thomas Reiberger, Mathias Jachs","doi":"10.1111/apt.70675","DOIUrl":"https://doi.org/10.1111/apt.70675","url":null,"abstract":"Background Bulevirtide (BLV) blocks hepatitis D virus (HDV) entry by targeting the sodium taurocholate co‐transporting polypeptide (NTCP). This study assessed the relationship between bile acid (BA) levels and antiviral response to BLV. Methods Serum BA levels were monitored in HDV‐infected patients pre‐, under, and post BLV treatment. Virologic response (VR) was defined by ≥ 2log <jats:sub>10</jats:sub> decline in HDV‐RNA and discriminated versus virologic non‐response (VNR). Delta BA levels (ΔBA) were calculated and analysed in relation to HDV‐RNA dynamics. Finally, the effect of BLV treatment cessation on BA was investigated. Results Twenty five patients (48% male; advanced chronic liver disease [ACLD]: 92.0%, 17 patients with VR at W48) were included. Median baseline BA levels were significantly higher in patients with ACLD and portal hypertension ( <jats:italic>n</jats:italic> = 10; 19.2 vs. 5.1 μmol/L; <jats:italic>p</jats:italic> = 0.015). No difference in median on‐treatment BA levels was detected between patients achieving VR or VNR at W24 (VR: 25.4 vs. VNR: 22.7 μmol/L; <jats:italic>p</jats:italic> = 1.000) and W48 (VR: 25.4 vs. VNR: 20.8 μmol/L; <jats:italic>p</jats:italic> = 1.000). Additionally, ΔBA from baseline to W48 did not differ between VR and VNR ( <jats:italic>p</jats:italic> = 0.534). No significant association between ΔBA and HDV‐RNA dynamics at W48 was detected. After BLV discontinuation, median BA levels significantly dropped to normal ranges (18.9 μmol/L at last on‐BLV assessment to 7.6 μmol/L after discontinuation; <jats:italic>p</jats:italic> = 0.028). On‐treatment BA levels did neither associate with self‐reported compliance nor with treatment‐related adverse events. Conclusion Bulevirtide increases bile acid levels in most patients, but ΔBA does not predict virologic response or adverse events, nor does it reflect compliance to therapy. Bile acid level monitoring during and following bulevirtide treatment is thus, not advised for clinical practise.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"32 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147725914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adriana Palom, Elisabetta Degasperi, Barbara Coco, Alessandro Loglio, Alessia Ciancio, Grazia Anna Niro, Mar Riveiro‐Barciela, Angela Carvalho‐Gomes, Javier García‐Samaniego, Sabela Lens, Ariadna Rando‐Segura, Dana Sambarino, Rosa Cotugno, Loretta A. Kondili, Maurizia Brunetto, Mauro Viganò, Pietro Lampertico, Maria Buti
{"title":"Baseline HDV ‐ RNA Levels Could Stratify Clinical Risk Before, But Not After, Cirrhosis in Chronic Hepatitis D: A Multicentre European Study","authors":"Adriana Palom, Elisabetta Degasperi, Barbara Coco, Alessandro Loglio, Alessia Ciancio, Grazia Anna Niro, Mar Riveiro‐Barciela, Angela Carvalho‐Gomes, Javier García‐Samaniego, Sabela Lens, Ariadna Rando‐Segura, Dana Sambarino, Rosa Cotugno, Loretta A. Kondili, Maurizia Brunetto, Mauro Viganò, Pietro Lampertico, Maria Buti","doi":"10.1111/apt.70695","DOIUrl":"https://doi.org/10.1111/apt.70695","url":null,"abstract":"Background and Aims Chronic hepatitis D (CHD) is associated with rapid progression to liver cirrhosis. However, the prognostic relevance of quantitative serum HDV‐RNA remains incompletely defined. We aimed to evaluate whether baseline HDV‐RNA levels are associated with the risk of liver‐related events in untreated patients with CHD and to validate these findings in two independent European cohorts. Methods We conducted a multicentre retrospective‐prospective cohort study including 260 untreated adults with CHD and detectable HDV‐RNA. Patients were derived from a Spanish derivation cohort ( <jats:italic>n</jats:italic> = 98) and two Italian validation cohorts ( <jats:italic>n</jats:italic> = 100 and <jats:italic>n</jats:italic> = 62). Baseline serum qHDV‐RNA was categorized in 1‐log increments starting from 6 IU/mL. Results During a median follow‐up of 4.1 years, 74 patients (28%) experienced at least one liver‐related event, with a significantly higher incidence in patients with cirrhosis than in those without cirrhosis ( <jats:italic>p</jats:italic> < 0.001). Among noncirrhotic patients, increasing baseline HDV‐RNA levels were consistently associated with a higher proportion of liver‐related events across derivation and validation cohorts, whereas no events occurred at the lowest HDV‐RNA category. In contrast, among patients with established cirrhosis, baseline HDV‐RNA levels were not associated with the occurrence of liver‐related events, and cumulative incidence was comparable across viral load categories. Conclusions Baseline quantitative HDV‐RNA allows early risk stratification in untreated patients with chronic hepatitis D before the development of liver cirrhosis. Once cirrhosis is established, clinical outcomes are largely independent of viral replication, emphasising the need to prioritise timely antiviral intervention and close surveillance at earlier disease stages.","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"46 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147725915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Editorial: The Role of Liver Biopsy in ANA Positive Subjects.","authors":"Einar S Björnsson","doi":"10.1111/apt.70698","DOIUrl":"https://doi.org/10.1111/apt.70698","url":null,"abstract":"","PeriodicalId":121,"journal":{"name":"Alimentary Pharmacology & Therapeutics","volume":"19 1","pages":""},"PeriodicalIF":7.6,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147719485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}