Factors Associated With Outcomes of Patients With Primary Sclerosing Cholangitis and Development and Validation of a Risk Scoring System

We sought to identify factors that are predictive of liver transplantation or death in patients with primary sclerosing cholangitis (PSC), and to develop and validate a contemporaneous risk score for use in a real‐world clinical setting. Analyzing data from 1,001 patients recruited to the UK‐PSC res...

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Published in:	Hepatology (Baltimore, Md.) Vol. 69; no. 5; pp. 2120 - 2135
Main Authors:	Goode, Elizabeth C., Clark, Allan B., Mells, George F., Srivastava, Brijesh, Spiess, Kelly, Gelson, William T.H., Trivedi, Palak J., Lynch, Kate D., Castren, Edit, Vesterhus, Mette N., Karlsen, Tom H., Ji, Sun‐Gou, Anderson, Carl A., Thorburn, Douglas, Hudson, Mark, Heneghan, Michael A., Aldersley, Mark A., Bathgate, Andrew, Sandford, Richard N., Alexander, Graeme J., Chapman, Roger W., Walmsley, Martine, Hirschfield, Gideon M., Rushbrook, Simon M.
Format:	Journal Article
Language:	English
Published:	United States Wolters Kluwer Health, Inc 01.05.2019 John Wiley and Sons Inc
Subjects:	Alkaline phosphatase Alkaline Phosphatase - blood Aspartate aminotransferase Bilirubin Cholangitis Cholangitis, Sclerosing - blood Cholangitis, Sclerosing - genetics Cholangitis, Sclerosing - mortality Cholangitis, Sclerosing - surgery Data processing Female Gallbladder diseases Hemorrhage Hepatology Heterozygosity Histocompatibility antigen HLA HLA Antigens - genetics Humans Liver Transplantation Male Middle Aged Original Phosphatase Platelets Risk Assessment Transplants & implants United Kingdom - epidemiology United Kingdom United Kingdom > UK
ISSN:	0270-9139, 1527-3350, 1527-3350
Online Access:	Get full text
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Abstract	We sought to identify factors that are predictive of liver transplantation or death in patients with primary sclerosing cholangitis (PSC), and to develop and validate a contemporaneous risk score for use in a real‐world clinical setting. Analyzing data from 1,001 patients recruited to the UK‐PSC research cohort, we evaluated clinical variables for their association with 2‐year and 10‐year outcome through Cox‐proportional hazards and C‐statistic analyses. We generated risk scores for short‐term and long‐term outcome prediction, validating their use in two independent cohorts totaling 451 patients. Thirty‐six percent of the derivation cohort were transplanted or died over a cumulative follow‐up of 7,904 years. Serum alkaline phosphatase of at least 2.4 × upper limit of normal at 1 year after diagnosis was predictive of 10‐year outcome (hazard ratio [HR] = 3.05; C = 0.63; median transplant‐free survival 63 versus 108 months; P < 0.0001), as was the presence of extrahepatic biliary disease (HR = 1.45; P = 0.01). We developed two risk scoring systems based on age, values of bilirubin, alkaline phosphatase, albumin, platelets, presence of extrahepatic biliary disease, and variceal hemorrhage, which predicted 2‐year and 10‐year outcomes with good discrimination (C statistic = 0.81 and 0.80, respectively). Both UK‐PSC risk scores were well‐validated in our external cohort and outperformed the Mayo Clinic and aspartate aminotransferase‐to‐platelet ratio index (APRI) scores (C statistic = 0.75 and 0.63, respectively). Although heterozygosity for the previously validated human leukocyte antigen (HLA)‐DR*03:01 risk allele predicted increased risk of adverse outcome (HR = 1.33; P = 0.001), its addition did not improve the predictive accuracy of the UK‐PSC risk scores. Conclusion: Our analyses, based on a detailed clinical evaluation of a large representative cohort of participants with PSC, furthers our understanding of clinical risk markers and reports the development and validation of a real‐world scoring system to identify those patients most likely to die or require liver transplantation.
AbstractList	We sought to identify factors that are predictive of liver transplantation or death in patients with primary sclerosing cholangitis (PSC), and to develop and validate a contemporaneous risk score for use in a real‐world clinical setting. Analyzing data from 1,001 patients recruited to the UK‐PSC research cohort, we evaluated clinical variables for their association with 2‐year and 10‐year outcome through Cox‐proportional hazards and C‐statistic analyses. We generated risk scores for short‐term and long‐term outcome prediction, validating their use in two independent cohorts totaling 451 patients. Thirty‐six percent of the derivation cohort were transplanted or died over a cumulative follow‐up of 7,904 years. Serum alkaline phosphatase of at least 2.4 × upper limit of normal at 1 year after diagnosis was predictive of 10‐year outcome (hazard ratio [HR] = 3.05; C = 0.63; median transplant‐free survival 63 versus 108 months; P < 0.0001), as was the presence of extrahepatic biliary disease (HR = 1.45; P = 0.01). We developed two risk scoring systems based on age, values of bilirubin, alkaline phosphatase, albumin, platelets, presence of extrahepatic biliary disease, and variceal hemorrhage, which predicted 2‐year and 10‐year outcomes with good discrimination (C statistic = 0.81 and 0.80, respectively). Both UK‐PSC risk scores were well‐validated in our external cohort and outperformed the Mayo Clinic and aspartate aminotransferase‐to‐platelet ratio index (APRI) scores (C statistic = 0.75 and 0.63, respectively). Although heterozygosity for the previously validated human leukocyte antigen (HLA)‐DR03:01 risk allele predicted increased risk of adverse outcome (HR = 1.33; P = 0.001), its addition did not improve the predictive accuracy of the UK‐PSC risk scores. Conclusion: Our analyses, based on a detailed clinical evaluation of a large representative cohort of participants with PSC, furthers our understanding of clinical risk markers and reports the development and validation of a real‐world scoring system to identify those patients most likely to die or require liver transplantation. We sought to identify factors that are predictive of liver transplantation or death in patients with primary sclerosing cholangitis (PSC), and to develop and validate a contemporaneous risk score for use in a real-world clinical setting. Analyzing data from 1,001 patients recruited to the UK-PSC research cohort, we evaluated clinical variables for their association with 2-year and 10-year outcome through Cox-proportional hazards and C-statistic analyses. We generated risk scores for short-term and long-term outcome prediction, validating their use in two independent cohorts totaling 451 patients. Thirty-six percent of the derivation cohort were transplanted or died over a cumulative follow-up of 7,904 years. Serum alkaline phosphatase of at least 2.4 × upper limit of normal at 1 year after diagnosis was predictive of 10-year outcome (hazard ratio [HR] = 3.05; C = 0.63; median transplant-free survival 63 versus 108 months; P < 0.0001), as was the presence of extrahepatic biliary disease (HR = 1.45; P = 0.01). We developed two risk scoring systems based on age, values of bilirubin, alkaline phosphatase, albumin, platelets, presence of extrahepatic biliary disease, and variceal hemorrhage, which predicted 2-year and 10-year outcomes with good discrimination (C statistic = 0.81 and 0.80, respectively). Both UK-PSC risk scores were well-validated in our external cohort and outperformed the Mayo Clinic and aspartate aminotransferase-to-platelet ratio index (APRI) scores (C statistic = 0.75 and 0.63, respectively). Although heterozygosity for the previously validated human leukocyte antigen (HLA)-DR03:01 risk allele predicted increased risk of adverse outcome (HR = 1.33; P = 0.001), its addition did not improve the predictive accuracy of the UK-PSC risk scores. Conclusion: Our analyses, based on a detailed clinical evaluation of a large representative cohort of participants with PSC, furthers our understanding of clinical risk markers and reports the development and validation of a real-world scoring system to identify those patients most likely to die or require liver transplantation.We sought to identify factors that are predictive of liver transplantation or death in patients with primary sclerosing cholangitis (PSC), and to develop and validate a contemporaneous risk score for use in a real-world clinical setting. Analyzing data from 1,001 patients recruited to the UK-PSC research cohort, we evaluated clinical variables for their association with 2-year and 10-year outcome through Cox-proportional hazards and C-statistic analyses. We generated risk scores for short-term and long-term outcome prediction, validating their use in two independent cohorts totaling 451 patients. Thirty-six percent of the derivation cohort were transplanted or died over a cumulative follow-up of 7,904 years. Serum alkaline phosphatase of at least 2.4 × upper limit of normal at 1 year after diagnosis was predictive of 10-year outcome (hazard ratio [HR] = 3.05; C = 0.63; median transplant-free survival 63 versus 108 months; P < 0.0001), as was the presence of extrahepatic biliary disease (HR = 1.45; P = 0.01). We developed two risk scoring systems based on age, values of bilirubin, alkaline phosphatase, albumin, platelets, presence of extrahepatic biliary disease, and variceal hemorrhage, which predicted 2-year and 10-year outcomes with good discrimination (C statistic = 0.81 and 0.80, respectively). Both UK-PSC risk scores were well-validated in our external cohort and outperformed the Mayo Clinic and aspartate aminotransferase-to-platelet ratio index (APRI) scores (C statistic = 0.75 and 0.63, respectively). Although heterozygosity for the previously validated human leukocyte antigen (HLA)-DR*03:01 risk allele predicted increased risk of adverse outcome (HR = 1.33; P = 0.001), its addition did not improve the predictive accuracy of the UK-PSC risk scores. Conclusion: Our analyses, based on a detailed clinical evaluation of a large representative cohort of participants with PSC, furthers our understanding of clinical risk markers and reports the development and validation of a real-world scoring system to identify those patients most likely to die or require liver transplantation.
Author	Mells, George F. Ji, Sun‐Gou Clark, Allan B. Alexander, Graeme J. Thorburn, Douglas Goode, Elizabeth C. Hudson, Mark Srivastava, Brijesh Hirschfield, Gideon M. Castren, Edit Karlsen, Tom H. Sandford, Richard N. Rushbrook, Simon M. Spiess, Kelly Gelson, William T.H. Aldersley, Mark A. Chapman, Roger W. Walmsley, Martine Anderson, Carl A. Heneghan, Michael A. Trivedi, Palak J. Bathgate, Andrew Lynch, Kate D. Vesterhus, Mette N.
AuthorAffiliation	17 Scottish Liver Transplant Unit Royal Infirmary of Edinburgh Edinburgh United Kingdom 2 Academic Department of Medical Genetics Addenbrooke's Hospital, University of Cambridge Cambridge United Kingdom 9 Toronto Centre for Liver Disease University Health Network and University of Toronto Toronto Canada 12 Institute of Clinical Medicine, Faculty of Medicine University of Oslo Oslo Norway 6 National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre Birmingham United Kingdom 5 Cambridge Transplant Centre Addenbrooke's Hospital Cambridge United Kingdom 7 Institute of Immunology & Immunotherapy University of Birmingham Birmingham United Kingdom 14 Liver Medicine and Transplantation Service Freeman Hospital Newcastle United Kingdom 16 Department of Hepatology Leeds Teaching Hospital Leeds United Kingdom 18 PSC Support Oxfordshire United Kingdom 1 Norfolk and Norwich University Hospital Norwich United Kingdom 8 Centre for Rare Diseases, Institute of Translational Medicine Unive
AuthorAffiliation_xml	– name: 11 Norwegian PSC Research Center, Department of Transplantation Medicine Oslo University Hospital Rikshospitalet Oslo Norway – name: 16 Department of Hepatology Leeds Teaching Hospital Leeds United Kingdom – name: 13 Sheila Sherlock Liver Centre, Royal Free Hospital London United Kingdom – name: 17 Scottish Liver Transplant Unit Royal Infirmary of Edinburgh Edinburgh United Kingdom – name: 1 Norfolk and Norwich University Hospital Norwich United Kingdom – name: 15 Institute of Liver Studies Kings College Hospital London United Kingdom – name: 2 Academic Department of Medical Genetics Addenbrooke's Hospital, University of Cambridge Cambridge United Kingdom – name: 7 Institute of Immunology & Immunotherapy University of Birmingham Birmingham United Kingdom – name: 8 Centre for Rare Diseases, Institute of Translational Medicine University Hospitals Birmingham Birmingham United Kingdom – name: 4 Norwich Medical School University of East Anglia Norwich United Kingdom – name: 14 Liver Medicine and Transplantation Service Freeman Hospital Newcastle United Kingdom – name: 9 Toronto Centre for Liver Disease University Health Network and University of Toronto Toronto Canada – name: 6 National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre Birmingham United Kingdom – name: 5 Cambridge Transplant Centre Addenbrooke's Hospital Cambridge United Kingdom – name: 12 Institute of Clinical Medicine, Faculty of Medicine University of Oslo Oslo Norway – name: 10 Translational Gastroenterology Unit John Radcliffe Hospital, and Nuffield Department of Medicine, University of Oxford Oxford United Kingdom – name: 18 PSC Support Oxfordshire United Kingdom – name: 3 Wellcome Trust Sanger Institute Hinxton, Cambridge United Kingdom
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Copyright	2018 The Authors. Hepatology published by Wiley Periodicals, Inc. on behalf of American Association for the Study of Liver Diseases. 2019 by the American Association for the Study of Liver Diseases.
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Notes	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 ObjectType-Undefined-3 Potential conflict of interest: Dr. Bathgate received grants from Gilead. Dr. Hirschfield consults and received grants from Intercept; he consults for GlaxoSmithKline, Novartis, and Cymabay; he received grants from Gilead (to continue subsequent unrestricted support of the UK‐PSC cohort) and Falk. Dr. Rushbrook advises Falk and Intercept. Dr. Sandford received grants from Intercept. Dr. Vesterhus advises Intercept. Supported by the National Institute of Health Research (RD‐TRC and Birmingham Biomedical Research Centre); Isaac Newton Trust; Addenbrooke's Charitable Trust; Norwegian PSC Research Center; PSC Support; Lily and Terry Horner Chair in Autoimmune Liver Disease Research (to G.M.H.). E.C.G. is supported by a fellowship from the Wellcome Trust. These authors contributed equally to the work.
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Snippet	We sought to identify factors that are predictive of liver transplantation or death in patients with primary sclerosing cholangitis (PSC), and to develop and...
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SubjectTerms	Alkaline phosphatase Alkaline Phosphatase - blood Aspartate aminotransferase Bilirubin Cholangitis Cholangitis, Sclerosing - blood Cholangitis, Sclerosing - genetics Cholangitis, Sclerosing - mortality Cholangitis, Sclerosing - surgery Data processing Female Gallbladder diseases Hemorrhage Hepatology Heterozygosity Histocompatibility antigen HLA HLA Antigens - genetics Humans Liver Transplantation Male Middle Aged Original Phosphatase Platelets Risk Assessment Transplants & implants United Kingdom - epidemiology
Title	Factors Associated With Outcomes of Patients With Primary Sclerosing Cholangitis and Development and Validation of a Risk Scoring System
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