دورية أكاديمية
Adequate versus deep response to ursodeoxycholic acid in primary biliary cholangitis: To what extent and under what conditions is normal alkaline phosphatase level associated with complication-free survival gain?
| العنوان: | Adequate versus deep response to ursodeoxycholic acid in primary biliary cholangitis: To what extent and under what conditions is normal alkaline phosphatase level associated with complication-free survival gain? |
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| المؤلفون: | Corpechot C; Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Saint-Antoine Hospital, Assistance Publique-Hôpitaux de Paris; Inserm UMR_S938, Saint-Antoine Research Center, Sorbonne University, Paris, France., Lemoinne S; Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Saint-Antoine Hospital, Assistance Publique-Hôpitaux de Paris; Inserm UMR_S938, Saint-Antoine Research Center, Sorbonne University, Paris, France., Soret PA; Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Saint-Antoine Hospital, Assistance Publique-Hôpitaux de Paris; Inserm UMR_S938, Saint-Antoine Research Center, Sorbonne University, Paris, France., Hansen B; Department of Epidemiology & Biostatistics, Erasmus MC, Rotterdam, The Netherlands.; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada., Hirschfield G; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada., Gulamhusein A; Toronto Centre for Liver Disease, University Health Network, University of Toronto, Toronto, Ontario, Canada., Montano-Loza AJ; Division of Gastroenterology and Liver Unit, University of Alberta, Edmonton, Alberta, Canada., Lytvyak E; Division of Preventive Medicine, University of Alberta, Edmonton, Alberta, Canada., Pares A; Liver Unit, Hospital Clínic, University of Barcelona, The August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Diseases, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Barcelona, Spain., Olivas I; Liver Unit, Hospital Clínic, University of Barcelona, The August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Diseases, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Barcelona, Spain., Eaton JE; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota., Osman KT; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota., Schramm C; Department of Medicine I and Martin Zeitz Center for Rare Diseases, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Sebode M; Department of Medicine I and Martin Zeitz Center for Rare Diseases, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Lohse AW; Department of Medicine I and Martin Zeitz Center for Rare Diseases, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Dalekos G; Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN Rare-Liver), General University Hospital, Larissa, Greece., Gatselis N; Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Center of Greece in Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN Rare-Liver), General University Hospital, Larissa, Greece., Nevens F; Division of Hepatology and Liver Transplantation, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University Hospitals KU, Leuven, Belgium., Cazzagon N; Department of Surgery, Oncology and Gastroenterology, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University of Padova, Padova, Italy., Zago A; Department of Surgery, Oncology and Gastroenterology, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University of Padova, Padova, Italy., Russo FP; Department of Surgery, Oncology and Gastroenterology, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University of Padova, Padova, Italy., Floreani A; Department of Surgery, Oncology and Gastroenterology, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University of Padova, Padova, Italy., Abbas N; Liver Unit, University Hospitals Birmingham National Health Service Foundation Trust Queen Elizabeth, Birmingham, UK., Trivedi P; National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre (BRC), Institute of Immunology and Immunotherapy, Centre for Liver and Gastrointestinal Research, University of Birmingham, Birmingham, UK., Thorburn D; University College London Institute for Liver and Digestive Health, Royal Free Hospital, London, UK., Saffioti F; University College London Institute for Liver and Digestive Health, Royal Free Hospital, London, UK., Barkai L; University College London Institute for Liver and Digestive Health, Royal Free Hospital, London, UK., Roccarina D; University College London Institute for Liver and Digestive Health, Royal Free Hospital, London, UK., Calvaruso V; Section of Gastroenterology and Hepatology, PROMISE, University of Palermo, Palermo, Italy., Fichera A; Section of Gastroenterology and Hepatology, PROMISE, University of Palermo, Palermo, Italy., Delamarre A; Department of Hepatology, University Hospitals of Bordeaux, Pessac, France., Sobenko N; Department of Hepatology & Liver Transplantation, Italian Hospital of Buenos Aires, Buenos Aires, Argentina., Villamil AM; Department of Hepatology & Liver Transplantation, Italian Hospital of Buenos Aires, Buenos Aires, Argentina., Medina-Morales E; Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts., Bonder A; Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts., Patwardhan V; Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts., Rigamonti C; 9Department of Internal Medicine, Università del Piemonte Orientale, Novara, Italy., Carbone M; Division of Gastroenterology, Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University of Milano-Bicocca, Monza, Italy., Invernizzi P; Division of Gastroenterology, Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University of Milano-Bicocca, Monza, Italy., Cristoferi L; Division of Gastroenterology, Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, European Reference Network on Hepatological Diseases (ERN Rare-Liver), University of Milano-Bicocca, Monza, Italy., van der Meer A; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands., de Veer R; Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands., Zigmond E; The Research Center for Digestive Tract and Liver Diseases, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel., Yehezkel E; The Research Center for Digestive Tract and Liver Diseases, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel., Kremer AE; Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland., Deibel A; Department of Gastroenterology and Hepatology, University Hospital Zürich, Zürich, Switzerland., Bruns T; Department of Medicine III, University Hospital RWTH Aachen, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Aachen, Germany., Große K; Department of Medicine III, University Hospital RWTH Aachen, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Aachen, Germany., Wetten A; Department of Hepatology and Liver Transplantation, Newcastle Upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle Upon Tyne, UK., Dyson JK; Department of Hepatology and Liver Transplantation, Newcastle Upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle Upon Tyne, UK., Jones D; Department of Hepatology and Liver Transplantation, Newcastle Upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle Upon Tyne, UK., Dumortier J; Department of Gastroenterology and Hepatology, Edouard Herriot Hospital, Hospices Civils de Lyon, Claude Bernard University, Lyon, France., Pageaux GP; Department of Hepatology and Liver Transplantation, University Hospital, Montpellier, France., de Lédinghen V; Department of Hepatology, University Hospitals of Bordeaux, Pessac, France., Chazouillères O; Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Saint-Antoine Hospital, Assistance Publique-Hôpitaux de Paris; Inserm UMR_S938, Saint-Antoine Research Center, Sorbonne University, Paris, France., Carrat F; Public Health Unit, Saint-Antoine Hospital, Assistance Publique-Hôpitaux de Paris.; Pierre Louis Institute of Epidemiology and Public Health, Sorbonne University, Inserm, Paris, France. |
| مؤلفون مشاركون: | Global & ERN Rare-Liver PBC Study Groups |
| المصدر: | Hepatology (Baltimore, Md.) [Hepatology] 2024 Jan 01; Vol. 79 (1), pp. 39-48. Date of Electronic Publication: 2023 Jul 03. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wolters Kluwer Health, Inc Country of Publication: United States NLM ID: 8302946 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-3350 (Electronic) Linking ISSN: 02709139 NLM ISO Abbreviation: Hepatology Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2023- : [Philadelphia] : Wolters Kluwer Health, Inc. Original Publication: Baltimore, MD : Williams & Wilkins, [c1981]- |
| مواضيع طبية MeSH: | Ursodeoxycholic Acid*/therapeutic use , Liver Cirrhosis, Biliary*/complications , Liver Cirrhosis, Biliary*/drug therapy, Humans ; Middle Aged ; Alkaline Phosphatase ; Cholagogues and Choleretics/therapeutic use ; Retrospective Studies ; Treatment Outcome |
| مستخلص: | Background and Aims: Normal alkaline phosphatase (ALP) levels in ursodeoxycholic acid (UDCA)-treated patients with primary biliary cholangitis (PBC) are associated with better long-term outcome. However, second-line therapies are currently recommended only when ALP levels remain above 1.5 times the upper limit of normal (×ULN) after 12-month UDCA. We assessed whether, in patients considered good responders to UDCA, normal ALP levels were associated with significant survival gains. Approach and Results: We performed a retrospective cohort study of 1047 patients with PBC who attained an adequate response to UDCA according to Paris-2 criteria. Time to liver-related complications, liver transplantation, or death was assessed using adjusted restricted mean survival time (RMST) analysis. The overall incidence rate of events was 17.0 (95% CI: 13.7-21.1) per 1000 out of 4763.2 patient-years. On the whole population, normal serum ALP values (but not normal gamma-glutamyl transpeptidase (GGT), alanine aminotransferase (ALT), or aspartate aminotransferase (AST); or total bilirubin < 0.6 ×ULN) were associated with a significant absolute complication-free survival gain at 10 years (mean 7.6 months, 95% CI: 2.7 - 12.6 mo.; p = 0.003). In subgroup analysis, this association was significant in patients with a liver stiffness measurement ≥ 10 kPa and/or age ≤ 62 years, with a 10-year absolute complication-free survival gain of 52.8 months (95% CI: 45.7-59.9, p < 0.001) when these 2 conditions were met. Conclusions: PBC patients with an adequate response to UDCA and persistent ALP elevation between 1.1 and 1.5 ×ULN, particularly those with advanced fibrosis and/or who are sufficiently young, remain at risk of poor outcome. Further therapeutic efforts should be considered for these patients. (Copyright © 2023 American Association for the Study of Liver Diseases.) |
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| المشرفين على المادة: | 724L30Y2QR (Ursodeoxycholic Acid) EC 3.1.3.1 (Alkaline Phosphatase) 0 (Cholagogues and Choleretics) |
| تواريخ الأحداث: | Date Created: 20230703 Date Completed: 20231216 Latest Revision: 20240116 |
| رمز التحديث: | 20240117 |
| DOI: | 10.1097/HEP.0000000000000529 |
| PMID: | 37399238 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1527-3350 |
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| DOI: | 10.1097/HEP.0000000000000529 |