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1. A quantitative MRCP-derived score for medium-term outcome prediction in primary sclerosing cholangitis

Author

Laura Cristoferi, Marco Porta, Davide Paolo Bernasconi, Filippo Leonardi, Alessio Gerussi, Giacomo Mulinacci, Andrea Palermo, Camilla Gallo, Miki Scaravaglio, Eliana Stucchi, Cesare Maino, Davide Ippolito, Daphne D'Amato, Carlos Ferreira, Alessandra Nardi, Rajarshi Banerjee, Maria Grazia Valsecchi, Laura Antolini, Rocco Corso, Sandro Sironi, Stefano Fagiuoli, Pietro Invernizzi, Marco Carbone, Cristoferi, L, Porta, M, Bernasconi, D, Leonardi, F, Gerussi, A, Mulinacci, G, Palermo, A, Gallo, C, Scaravaglio, M, Stucchi, E, Maino, C, Ippolito, D, D'Amato, D, Ferreira, C, Nardi, A, Banerjee, R, Valsecchi, M, Antolini, L, Corso, R, Sironi, S, Fagiuoli, S, Invernizzi, P, and Carbone, M

Subjects
sclerosing cholangitis, Artificial intelligence, Hepatology, Prognostic score, Gastroenterology, Primary sclerosing cholangiti, MRCP
Abstract

Background: Magnetic resonance cholangiopancreatography (MRCP) is the gold standard for diagnosis of patients with primary sclerosing cholangitis (PSC). The semi-quantitative MRCP-derived Anali scores proposed for risk stratification, have poor-to-moderate inter-reader agreement. Aims: To evaluate the prognostic performance of quantitative MRCP metrics in PSC. Methods: This is a retrospective study of PSC patients undergoing MRCP. Images were processed using MRCP+ software (Perspectum Ltd, Oxford) that provides quantitative biliary features, semi-automatically extracted by artificial intelligence-driven analysis of MRCP-3D images. The prognostic value of biliary features has been assessed for all hepato-biliary complications. Results: 87 PSC patients have been included in the analysis. Median follow-up from MRCP to event/censoring of 30.9 months (Q1-Q3=13.6–46.6). An adverse outcome occurred in 27 (31.0%) patients. The number of biliary strictures (HR=1.05 per unit, 95%CI 1.02–1.08, p < 0.0001), spleen length (HR=1.16 per cm, 95%CI 1.01–1.34, p = 0.039), adjusted for height, age at MRCP, and time from diagnosis to MRCP predicted higher risk of hepatobiliary complications. These were incorporated into a the quantitative MRCP-derived PSC (qMRCP-PSC) score (C-statistic=0.80). After 3-fold cross-validation, qMRCP-PSC outperformed the Anali score in our cohort (C-statistic of 0.78 vs 0.64) and enabled the discrimination of survival of PSC patients (log-rank p < 0.0001). Conclusions: The qMRCP-PSC score identified patients at higher risk of hepatobiliary complications and outperformed the available radiological scores. It represents a novel quantitative biomarker for disease monitoring and a potential surrogate endpoint for clinical trials.

Published
2023

3. Corrigendum to ‘An international genome-wide meta-analysis of primary biliary cholangitis: Novel risk loci and candidate drugs’ [J Hepatol 2021;75(3):572–581]

Author

Heather J. Cordell, James J. Fryett, Kazuko Ueno, Rebecca Darlay, Yoshihiro Aiba, Yuki Hitomi, Minae Kawashima, Nao Nishida, Seik-Soon Khor, Olivier Gervais, Yosuke Kawai, Masao Nagasaki, Katsushi Tokunaga, Ruqi Tang, Yongyong Shi, Zhiqiang Li, Brian D. Juran, Elizabeth J. Atkinson, Alessio Gerussi, Marco Carbone, Rosanna Asselta, Angela Cheung, Mariza de Andrade, Aris Baras, Julie Horowitz, Manuel A.R. Ferreira, Dylan Sun, David E. Jones, Steven Flack, Ann Spicer, Victoria L. Mulcahy, Jinyoung Byun, Younghun Han, Richard N. Sandford, Konstantinos N. Lazaridis, Christopher I. Amos, Gideon M. Hirschfield, Michael F. Seldin, Pietro Invernizzi, Katherine A. Siminovitch, Xiong Ma, Minoru Nakamura, George F. Mells, Andrew Mason, Catherine Vincent, Gang Xie, Jinyi Zhang, Andrea Affronti, Piero L. Almasio, Domenico Alvaro, Pietro Andreone, Angelo Andriulli, Francesco Azzaroli, Pier Maria Battezzati, Antonio Benedetti, Maria Consiglia Bragazzi, Maurizia Brunetto, Savino Bruno, Vincenza Calvaruso, Vincenzo Cardinale, Giovanni Casella, Nora Cazzagon, Antonio Ciaccio, Barbara Coco, Agostino Colli, Guido Colloredo, Massimo Colombo, Silvia Colombo, Laura Cristoferi, Carmela Cursaro, Lory Saveria Crocè, Andrea Crosignani, Daphne D’Amato, Francesca Donato, Gianfranco Elia, Luca Fabris, Stefano Fagiuoli, Carlo Ferrari, Annarosa Floreani, Andrea Galli, Edoardo Giannini, Ignazio Grattagliano, Pietro Lampertico, Ana Lleo, Federica Malinverno, Clara Mancuso, Fabio Marra, Marco Marzioni, Sara Massironi, Alberto Mattalia, Luca Miele, Chiara Milani, Lorenzo Morini, Filomena Morisco, Luigi Muratori, Paolo Muratori, Grazia A. Niro, Sarah O’Donnell, Antonio Picciotto, Piero Portincasa, Cristina Rigamonti, Vincenzo Ronca, Floriano Rosina, Giancarlo Spinzi, Mario Strazzabosco, Mirko Tarocchi, Claudio Tiribelli, Pierluigi Toniutto, Luca Valenti, Maria Vinci, Massimo Zuin, Hitomi Nakamura, Seigo Abiru, Shinya Nagaoka, Atsumasa Komori, Hiroshi Yatsuhashi, Hiromi Ishibashi, Masahiro Ito, Kiyoshi Migita, Hiromasa Ohira, Shinji Katsushima, Atsushi Naganuma, Kazuhiro Sugi, Tatsuji Komatsu, Tomohiko Mannami, Kouki Matsushita, Kaname Yoshizawa, Fujio Makita, Toshiki Nikami, Hideo Nishimura, Hiroshi Kouno, Hirotaka Kouno, Hajime Ota, Takuya Komura, Yoko Nakamura, Masaaki Shimada, Noboru Hirashima, Toshiki Komeda, Keisuke Ario, Makoto Nakamuta, Tsutomu Yamashita, Kiyoshi Furuta, Masahiro Kikuchi, Noriaki Naeshiro, Hironao Takahashi, Yutaka Mano, Seiji Tsunematsu, Iwao Yabuuchi, Yusuke Shimada, Kazuhiko Yamauchi, Rie Sugimoto, Hironori Sakai, Eiji Mita, Masaharu Koda, Satoru Tsuruta, Hiroshi Kamitsukasa, Takeaki Sato, Naohiko Masaki, Tatsuro Kobata, Nobuyoshi Fukushima, Yukio Ohara, Toyokichi Muro, Eiichi Takesaki, Hitoshi Takaki, Tetsuo Yamamoto, Michio Kato, Yuko Nagaoki, Shigeki Hayashi, Jinya Ishida, Yukio Watanabe, Masakazu Kobayashi, Michiaki Koga, Takeo Saoshiro, Michiyasu Yagura, Keisuke Hirata, Atsushu Tanaka, Hajime Takikawa, Mikio Zeniya, Masanori Abe, Morikazu Onji, Shuichi Kaneko, Masao Honda, Kuniaki Arai, Teruko Arinaga-Hino, Etsuko Hashimoto, Makiko Taniai, Takeji Umemura, Satoru Joshita, Kazuhiko Nakao, Tatsuki Ichikawa, Hidetaka Shibata, Satoshi Yamagiwa, Masataka Seike, Koichi Honda, Shotaro Sakisaka, Yasuaki Takeyama, Masaru Harada, Michio Senju, Osamu Yokosuka, Tatsuo Kanda, Yoshiyuki Ueno, Kentaro Kikuchi, Hirotoshi Ebinuma, Takashi Himoto, Michio Yasunami, Kazumoto Murata, Masashi Mizokami, Kazuhito Kawata, Shinji Shimoda, Yasuhiro Miyake, Akinobu Takaki, Kazuhide Yamamoto, Katsuji Hirano, Takafumi Ichida, Akio Ido, Hirohito Tsubouchi, Kazuaki Chayama, Kenichi Harada, Yasuni Nakanuma, Yoshihiko Maehara, Akinobu Taketomi, Ken Shirabe, Yuji Soejima, Akira Mori, Shintaro Yagi, Shinji Uemoto, Egawa H, Tomohiro Tanaka, Noriyo Yamashiki, Sumito Tamura, Yasuhiro Sugawara, Norihiro Kokudo, Naga Chalasani, Vel Luketic, Joseph Odin, Kapil Chopra, Goncalo Abecasis, Michael Cantor, Giovanni Coppola, Aris Economides, Luca A. Lotta, John D. Overton, Jeffrey G. Reid, Alan Shuldiner, Christina Beechert, Caitlin Forsythe, Erin D. Fuller, Zhenhua Gu, Michael Lattari, Alexander Lopez, Thomas D. Schleicher, Maria Sotiropoulos Padilla, Karina Toledo, Louis Widom, Sarah E. Wolf, Manasi Pradhan, Kia Manoochehri, Ricardo H. Ulloa, Xiaodong Bai, Suganthi Balasubramanian, Leland Barnard, Andrew Blumenfeld, Gisu Eom, Lukas Habegger, Alicia Hawes, Shareef Khalid, Evan K. Maxwell, William Salerno, Jeffrey C. Staples, Marcus B. Jones, Lyndon J. Mitnaul, Richard Sturgess, Christopher Healey, Andrew Yeoman, Anton V.J. Gunasekera, Paul Kooner, Kapil Kapur, V. Sathyanarayana, Yiannis Kallis, Javaid Subhani, Rory Harvey, Roger McCorry, Paul Rooney, David Ramanaden, Richard Evans, Thiriloganathan Mathialahan, Jaber Gasem, Christopher Shorrock, Mahesh Bhalme, Paul Southern, Jeremy A. Tibble, David A. Gorard, Susan Jones, George Mells, Victoria Mulcahy, Brijesh Srivastava, Matthew R. Foxton, Carole E. Collins, David Elphick, Mazn Karmo, Francisco Porras-Perez, Michael Mendall, Tom Yapp, Minesh Patel, Roland Ede, Joanne Sayer, James Jupp, Neil Fisher, Martyn J. Carter, Konrad Koss, Jayshri Shah, Andrzej Piotrowicz, Glyn Scott, Charles Grimley, Ian R. Gooding, Simon Williams, Judith Tidbury, Guan Lim, Kuldeep Cheent, Sass Levi, Dina Mansour, Matilda Beckley, Coral Hollywood, Terry Wong, Richard Marley, John Ramage, Harriet M. Gordon, Jo Ridpath, Theodore Ngatchu, Vijay Paul Bob Grover, Ray G. Shidrawi, George Abouda, L. Corless, Mark Narain, Ian Rees, Ashley Brown, Simon Taylor-Robinson, Joy Wilkins, Leonie Grellier, Paul Banim, Debasish Das, Michael A. Heneghan, Howard Curtis, Helen C. Matthews, Faiyaz Mohammed, Mark Aldersley, Raj Srirajaskanthan, Giles Walker, Alistair McNair, Amar Sharif, Sambit Sen, George Bird, Martin I. Prince, Geeta Prasad, Paul Kitchen, Adrian Barnardo, Chirag Oza, Nurani N. Sivaramakrishnan, Prakash Gupta, Amir Shah, Chris D.J. Evans, Subrata Saha, Katharine Pollock, Peter Bramley, Ashis Mukhopadhya, Stephen T. Barclay, Natasha McDonald, Andrew J. Bathgate, Kelvin Palmer, John F. Dillon, Simon M. Rushbrook, Robert Przemioslo, Chris McDonald, Andrew Millar, Cheh Tai, Stephen Mitchell, Jane Metcalf, Syed Shaukat, Mary Ninkovic, Udi Shmueli, Andrew Davis, Asifabbas Naqvi, Tom J.W. Lee, Stephen Ryder, Jane Collier, Howard Klass, Matthew E. Cramp, Nichols Sharer, Richard Aspinall, Deb Ghosh, Andrew C. Douds, Jonathan Booth, Earl Williams, Hyder Hussaini, John Christie, Steven Mann, Douglas Thorburn, Aileen Marshall, Imran Patanwala, Aftab Ala, Julia Maltby, Ray Matthew, Chris Corbett, Sam Vyas, Saket Singhal, Dermot Gleeson, Sharat Misra, Jeff Butterworth, Keith George, Tim Harding, Andrew Douglass, Harriet Mitchison, Simon Panter, Jeremy Shearman, Gary Bray, Michael Roberts, Graham Butcher, Daniel Forton, Zahid Mahmood, Matthew Cowan, Debashis Das, Chin Lye Ch'ng, Mesbah Rahman, Gregory C.A. Whatley, Emma Wesley, Aditya Mandal, Sanjiv Jain, Stephen P. Pereira, Mark Wright, Palak Trivedi, Fiona H. Gordon, Esther Unitt, Altaf Palejwala, Andrew Austin, Vishwaraj Vemala, Allister Grant, Andrew D. Higham, Alison Brind, Ray Mathew, Mark Cox, Subramaniam Ramakrishnan, Alistair King, Simon Whalley, Jocelyn Fraser, S.J. Thomson, Andrew Bell, Voi Shim Wong, Richard Kia, Ian Gee, Richard Keld, Rupert Ransford, James Gotto, and Charles Millson

Subjects
Science & Technology, Hepatology, Gastroenterology & Hepatology, Italian PBC Study Group, Japan-PBC-GWAS Consortium, UK-PBC Consortium, Chinese PBC Consortium, 1103 Clinical Sciences, US PBC Consortium, Canadian PBC Consortium, Life Sciences & Biomedicine, PBC Consortia, 1117 Public Health and Health Services
Published
2021

4. SARS-CoV-2 vaccination and risk of severe COVID-19 outcomes in patients with autoimmune hepatitis

Author

Cumali Efe, Koray Taşçılar, Alessio Gerussi, Francesca Bolis, Craig Lammert, Berat Ebik, Albert Friedrich Stättermayer, Mustafa Cengiz, Dilara Turan Gökçe, Laura Cristoferi, Mirta Peralta, Hatef Massoumi, Pedro Montes, Eira Cerda, Cristina Rigamonti, Suna Yapalı, Gupse Adali, Ali Rıza Çalışkan, Yasemin Balaban, Fatih Eren, Tuğçe Eşkazan, Sezgin Barutçu, Ellina Lytvyak, Godolfino Miranda Zazueta, Meral Akdogan Kayhan, Alexandra Heurgue-Berlot, Eleonora De Martin, Ahmet Yavuz, Murat Bıyık, Graciela Castro Narro, Serkan Duman, Nelia Hernandez, Nikolaos K. Gatselis, Jonathan Aguirre, Ramazan Idilman, Marcelo Silva, Manuel Mendizabal, Kadri Atay, Fatih Güzelbulut, Renumathy Dhanasekaran, Aldo J. Montano-Loza, George N. Dalekos, Ezequiel Ridruejo, Pietro Invernizzi, Staffan Wahlin, Acibadem University Dspace, Efe, C, Tascilar, K, Gerussi, A, Bolis, F, Lammert, C, Ebik, B, Stattermayer, A, Cengiz, M, Gokce, D, Cristoferi, L, Peralta, M, Massoumi, H, Montes, P, Cerda, E, Rigamonti, C, Yapali, S, Adali, G, Caliskan, A, Balaban, Y, Eren, F, Eskazan, T, Barutcu, S, Lytvyak, E, Zazueta, G, Kayhan, M, Heurgue-Berlot, A, De Martin, E, Yavuz, A, Biyik, M, Narro, G, Duman, S, Hernandez, N, Gatselis, N, Aguirre, J, Idilman, R, Silva, M, Mendizabal, M, Atay, K, Guzelbulut, F, Dhanasekaran, R, Montano-Loza, A, Dalekos, G, Ridruejo, E, Invernizzi, P, and Wahlin, S

Subjects
Adult, Aged, 80 and over, Male, COVID-19 Vaccines, Adolescent, SARS-CoV-2, Vaccination, Immunology, Liver failure, COVID-19, Autoimmunity, Middle Aged, Breakthrough infection, Young Adult, Hepatitis, Autoimmune, COVID-19 Testing, Humans, Immunology and Allergy, Female, Vaccine, BNT162 Vaccine, Immunosuppression, Aged, Retrospective Studies
Abstract

Background: Data regarding outcome of Coronavirus disease 2019 (COVID-19) in vaccinated patients with autoimmune hepatitis (AIH) are lacking. We evaluated the outcome of COVID-19 in AIH patients who received at least one dose of Pfizer- BioNTech (BNT162b2), Moderna (mRNA-1273) or AstraZeneca (ChAdOx1-S) vaccine. Patients and methods: We performed a retrospective study on AIH patients with COVID-19. The outcomes of AIH patients who had acute respiratory syndrome coronavirus 2 (SARS-CoV-2) breakthrough infection after at least one dose of COVID-19 vaccine were compared to unvaccinated patients with AIH. COVID-19 outcome was classified according to clinical state during the disease course as: (i) no hospitalization, (ii) hospitalization without oxygen supplementation, (iii) hospitalization with oxygen supplementation by nasal cannula or mask, (iv) intensive care unit (ICU) admission with non-invasive mechanical ventilation, (v) ICU admission with invasive mechanical ventilation or (vi) death, and data was analyzed using ordinal logistic regression. Results: We included 413 (258 unvaccinated and 155 vaccinated) patients (81\%, female) with a median age of 52 (range: 17-85) years at COVID-19 diagnosis. The rates of hospitalization were (36.4\% vs. 14.2\%), need for any supplemental oxygen (29.5\% vs. 9\%) and mortality (7\% vs. 0.6\%) in unvaccinated and vaccinated AIH patients with COVID-19. Having received at least one dose of SARS-CoV-2 vaccine was associated with a significantly lower risk of worse COVID-19 severity, after adjusting for age, sex, comorbidities and presence of cirrhosis (adjusted odds ratio {[}aOR] 0.18, 95\% confidence interval {[}CI], 0.10-0.31). Overall, vaccination against SARSCoV-2 was associated with a significantly lower risk of mortality from COVID-19 (aOR 0.20, 95\% CI 0.11-0.35). Conclusions: SARS-CoV-2 vaccination significantly reduced the risk of COVID-19 severity and mortality in patients with AIH.

Published
2022

5. Prognostic models in primary biliary cholangitis

Author

George F. Mells, Ronca, Marco Carbone, Pietro Invernizzi, Alessandra Nardi, Laura Cristoferi, Cristoferi, L, Nardi, A, Ronca, V, Invernizzi, P, Mells, G, and Carbone, M

Subjects
0301 basic medicine, Cholagogues and Choleretics, medicine.medical_specialty, Prognostic variable, Prognostic models, Immunology, Disease, Risk Assessment, Settore MED/01 - Statistica Medica, Machine Learning, 03 medical and health sciences, 0302 clinical medicine, MED/12 - GASTROENTEROLOGIA, Risk Factors, medicine, Animals, Humans, Metabolomics, Immunology and Allergy, Precision Medicine, Biomarker discovery, Intensive care medicine, Risk management, Settore MED/12 - Gastroenterologia, Models, Statistical, Whole Genome Sequencing, Liver Cirrhosis, Biliary, business.industry, Alkaline phosphatase, Personalised medicine, Primary biliary cholangitis, Risk prediction, Ursodeoxycholic Acid, Genomics, Alkaline Phosphatase, Prognosis, Molecular diagnostics, Omics, Clinical trial, Treatment Outcome, 030104 developmental biology, Primary biliary cholangiti, 030211 gastroenterology & hepatology, Prognostic model, business, Risk assessment, Biomarkers
Abstract

Risk prediction modelling is important to better understand the determinants of the course and outcome of PBC and to inform the risk across the disease continuum in PBC enabling risk-stratified follow-up care and personalised therapy. Current prognostic models in PBC are based on treatment response to ursodeoxycholic acid because of the well-established relationship between alkaline phosphatase on treatment and long-term outcome. In addition, serum alkaline phosphatase correlates with ductular reaction and biliary metaplasia, which are hallmark of biliary injury. Considering the waiting time for treatment failure in high-risk patients is not inconsequential, efforts are focused on bringing forward risk stratification at diagnosis by predicting treatment response at onset. There is a need for better prognostic variables that are central to the disease process. We should take an integrative approach that incorporates multiple layers of information including genetic and environmental influences, host characteristics, clinical data, and molecular alterations for risk assessments. Biomarker discovery has an accelerated pace taking advantage of the emergence of large-scale omics platforms (genomics, epigenomics, transcriptomics, proteomics, metabolomics, and others) and whole-genome sequencing. In the digital era, applications of artificial intelligence, such as machine learning, can support the computing power required to analyse the vast amount of data produced by omics. The information is then used for the development of personalised risk prediction models that through clinical trials and hopefully industry partnerships can guide risk management strategies. We are facing an unprecedented opportunity for the integration of molecular diagnostics into the clinic, which promotes progress toward the personalised management of patients with PBC.

Published
2018

6. The immunobiology of female predominance in primary biliary cholangitis

Author

Alessio Gerussi, Rosanna Asselta, Laura Cristoferi, Marco Carbone, Pietro Invernizzi, Gerussi, A, Cristoferi, L, Carbone, M, Asselta, R, and Invernizzi, P

Subjects
Male, 0301 basic medicine, Immunology, ARE-Del−/− mice, Gene Expression, Autoimmunity, Disease, Biology, medicine.disease_cause, Bioinformatics, Autoimmune Diseases, Epigenesis, Genetic, Interferon-gamma, Mice, 03 medical and health sciences, Sex Factors, 0302 clinical medicine, HLA Antigens, T-Lymphocyte Subsets, medicine, Animals, Humans, Immunology and Allergy, Genetic Predisposition to Disease, Epigenetics, Microbiome, Gonadal Steroid Hormones, X chromosome, Mice, Knockout, Chromosomes, Human, X, Liver Cirrhosis, Biliary, Epigenetic, Microchimerism, Epigenome, Phenotype, Female preponderance, Disease Models, Animal, 030104 developmental biology, Primary biliary cholangiti, 030220 oncology & carcinogenesis, Female, Sex chromosome
Abstract

Primary biliary cholangitis (PBC) is an autoimmune liver disease with a striking female preponderance. The mechanisms behind this predominance are still to be elucidated, although multiple theories have been postulated and investigated. Among the proposed involved factors, sex hormones have been the first to be studied, but unfortunately data have been inconclusive or conflicting. Similarly, fetal microchimerism has received a huge attention in the past, but data in PBC have been unsatisfactory especially if compared to other autoimmune diseases like systemic lupus erythematosus. Studies focused on genetic factors have generated more intriguing and robust data, reporting a few abnormalities on the X chromosome in PBC patients. However, these data are able to explain only a part of the phenotypic variability attributed to the genetic component, and most importantly, need to be validated in larger series. More recently, a novel mice model of PBC, characterised by a constitutive expression of Interferon-γ (IFN-γ), has been developed and it is notable for being the first one with female predominance. At the same time, there has been a wide interest in the role of microbiome in health and disease, as well as in epigenetics, which have tried to explain differences in biological phenotypes not covered by genetics. The aim of this review is to outline established knowledge on the topic and try to provide novel perspectives on the potential future applications of newer techniques addressing microbiome and epigenome, in order to further understand the biology of sex divergence in PBC.

Published
2018

8. EP1211: RADIOMICS-BASED MODEL FOR OUTCOME PREDICTION IN PRIMARY SCLEROSING CHOLANGITIS

Author

Laura Cristoferi, Marco Porta, Davide Paolo Bernasconi, Filippo Leonardi, Giacomo Mulinacci, Andrea Palermo, Alessio Gerussi, Camilla Gallo, Miki Scaravaglio, Eliana Stucchi, Cesare Maino, Davide Ippolito, Daphne D'Amato, Carlos Ferreira, Marija Mavar, Rajarshi Banerjee, Laura Antolini, Maria Grazia Valsecchi, Stefano Fagiuoli, Pietro Invernizzi, and Marco Carbone

Subjects
Hepatology, Gastroenterology
Published
2022

9. Optimising the clinical strategy for autoimmune liver diseases: Principles of value-based medicine

Author

Marta Gemma, Stefano Fagiuoli, Luca Fabris, Gaetano Ideo, Matteo Rota, Marco Carbone, Giancarlo Cesana, S. Okolicsanyi, Luca Maria Munari, Michele Colledan, A. Ciaccio, Paolo Cortesi, Luciana Scalone, Laura Cristoferi, Lorenzo G. Mantovani, Mario Strazzabosco, Luca S. Belli, Carbone, M, Cristoferi, L, Cortesi, P, Rota, M, Ciaccio, A, Okolicsanyi, S, Gemma, M, Scalone, L, Cesana, G, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Belli, L, Munari, L, Mantovani, L, and Strazzabosco, M

Subjects
Male, 0301 basic medicine, Delphi Technique, Delphi method, Autoimmune hepatitis, Tertiary Care Centers, 0302 clinical medicine, MED/12 - GASTROENTEROLOGIA, Multidisciplinary approach, Outcome Assessment, Health Care, Prospective Studies, Incidence, Primary sclerosing cholangitis, Electronic medical record, Clinical performance, Benchmarking, Middle Aged, Primary sclerosing cholangiti, Hepatitis, Autoimmune, Italy, Primary biliary cholangiti, Value-based medicine, Critical Pathways, Molecular Medicine, Female, 030211 gastroenterology & hepatology, Adult, medicine.medical_specialty, Primary biliary cholangitis, Molecular Biology, MED/42 - IGIENE GENERALE E APPLICATA, Cholangitis, Sclerosing, Autoimmune hepatiti, Autoimmune Diseases, Orphan drug, 03 medical and health sciences, medicine, Humans, Intensive care medicine, MED/01 - STATISTICA MEDICA, Aged, Quality Indicators, Health Care, business.industry, medicine.disease, Survival Analysis, 030104 developmental biology, business, Follow-Up Studies
Abstract

Background Autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis represent the three major autoimmune liver diseases (AILDs). Their management is highly specialized, requires a multidisciplinary approach and often relies on expensive, orphan drugs. Unfortunately, their treatment is often unsatisfactory, and the care pathway heterogeneous across different centers. Disease-specific clinical outcome indicators (COIs) able to evaluate the whole cycle of care are needed to assist both clinicians and administrators in improving quality and value of care. Aim of our study was to generate a set of COIs for the three AILDs. We then prospectively validated these indicators based on a series of consecutive patients recruited at three tertiary clinical centers in Lombardy, Italy. Methods In phase I using a Delphi method and a RAND 9-point appropriateness scale a set of COIs was generated. In phase II the indicators were applied in a real-life dataset. Results Two-hundred fourteen patients were enrolled and followed-up for a median time of 54 months and the above COIs were recorded using a web-based electronic medical record program. The COIs were easy to collect in the clinical practice environment and their values compared well with the available natural history studies. Conclusions We have generated a comprehensive set of COIs which sequentially capture different clinical outcome of the three AILDs explored. These indicators represent a critical tool to implement a value-based approach to patients with these conditions, to monitor, compare and improve quality through benchmarking of clinical performance and to assess the significance of novel drugs and technologies. This article is part of a Special Issue entitled: Cholangiocytes in Health and Diseaseedited by Jesus Banales, Marco Marzioni, Nicholas LaRusso and Peter Jansen.

Published
2018

10. Primary biliary cholangitis: a multifaceted pathogenesis with potential therapeutic targets

Author

Chiara Milani, Vincenzo Ronca, Marco Carbone, Laura Cristoferi, Pietro Invernizzi, Alessio Gerussi, Carbone, M, Milani, C, Gerussi, A, Ronca, V, Cristoferi, L, and Invernizzi, P

Subjects
medicine.medical_specialty, Primary (chemistry), Hepatology, Biliary cirrhosi, business.industry, Biliary cirrhosis, Biliary fibrosis, Autoimmunity, PBC, medicine.disease, medicine.disease_cause, Gastroenterology, Pathogenesis, Cholestasis, Cholestasi, Internal medicine, Biliary fibrosi, medicine, business
Published
2020

11. Accuracy of liver stiffness measurement in assessing liver fibrosis in naive patients with primary biliary cholangitis

Author

LAURA CRISTOFERI, Nardi, Alessandra, Vigano, Mauro, Rigamonti, Cristina, Degasperi, Elisabetta, Cardinale, Vincenzo, Labanca, Sara, Zucchini, Nicola, Leutner, Monica, Venere, Rosanna, Picciotto, Antonino, Cazzagon, Nora, Luca, Martina, Overi, Diletta, Gerussi, Alessio, D Amato, Daphne, O Donnell, Sarah Elisabeth, Cerini, Federica, Benedittis, Carla, Cadamuro, Massimiliano, Malinverno, Federica, Floreani, Annarosa, Alvaro, Domenico, Gaudio, Eugenio, Invernizzi, Pietro, Carpino, Guido, Carbone, Marco, Cristoferi, L, Nardi, A, Viganò, M, Rigamonti, C, Degasperi, E, Cardinale, V, Labanca, S, Zucchini, N, Leutner, M, Venere, R, Picciotto, A, Cazzagon, N, Lucà, M, Overi, D, Gerussi, A, D’Amato, D, O’Donnell, S, Cerini, F, De Benedittis, C, Cadamuro, M, Malinverno, F, Floreani, A, Alvaro, D, Gaudio, E, Invernizzi, P, Carpino, G, and Carbone, M

Subjects
Hepatology, Primary biliary cholangiti, Fibrosi, Autoimmune liver disease, Vibration-Controlled Transient Elastography, Risk stratification
Abstract

Background and Aims: Non-invasive evaluation of liver fibrosis in primary biliary cholangitis (PBC) with Liver Stiffness Measurements (LSM) by Transient Elastography (TE) is routinely undertaken at diagnosis for disease staging and risk stratification. However, evidence on correlation between LSM and liver fibrosis is based on cross-sectional studies in PBC-treated patients. Moreover, the impact of potential confounders, e.g. cholestasis and steatosis, is unclear. Aim of our study was to investigate the accuracy of LSM to predict moderate to severe fibrosis in newly diagnosed PBC patients naïve to therapy. Method: We collected data from 182 adult patients who underwent liver biopsy (LB) for PBC at diagnosis in five Italian liver centers from Jan 2006 through Aug 2019. TE examinations within 3 months from LB were included. LB were scored centrally by two expert pathologists, blinded to clinical data and disease stage, according to Ludwig staging system. In all patients Fibrosis-4 (FIB-4) and aspartate aminotransferase [AST]/platelet ratio (APRI) score have been calculated. Diagnostic accuracy of LSM, FIB-4 and APRI score was estimated using the area under the receiver operating characteristic curves (AUROCs) for fibrosis. The effects of liver biochemistry and histological parameters were appraised using multivariable logistic model. Results: 123 PBC patients had adequate LB (≥9 portal tracts) and valid LSM values. According to histological assessment, Ludwig stage distribution was as follows: stage I = 38 (30.9%), stage II = 46(37.4%), stage III = 27 (21.9%), stage IV = 12 (9.8%). TE identified patients with Ludwig stage III/IV with an AUROC of 0.83 (95% confidence interval [CI] (0.74, 0.90)) (Fig.1). The optimal threshold was identified at 6.75kPa (CI (6.55, 7.50)), with 85% of sensitivity, 75% of specificity, 78% of accuracy and 6 false negative. TE was superior to APRI and FIB-4 having AUROC of 0.638 (CI = (0.535, 0.740)) and 0.641 (CI = (0.516, 0.766)), respectively. At multivariable analysis only LSM was associated with liver fibrosis and no significant effect of biochemical measures and steatosis was found. Conclusion: LSM is accurate to predict moderate to severe liver fibrosis at diagnosis in PBC naïve patients using a threshold of 6.75kPa with an AUROC of 0.83. TE outperformed FIB-4 and APRI score and is not confounded by liver biochemistry and steatosis. These data can inform strategies for patient surveillance and trial design in PBC.

Published
2020

13. Pre-treatment risk stratification in primary biliary cholangitis: a predictive model to guide first-line combination therapy

Author

Simon D. Taylor-Robinson, Michael A. Heneghan, Marco Carbone, E.G. Giannini, Pietro Invernizzi, Massimo Zuin, Luca Miele, Vincenzo Cardinale, Andrew Bathgate, Giulia Bonato, Richard Sandford, D.E.J. Jones, Guido Carpino, Holly F. Ainsworth, Fabio Marra, G. Hirschfield, D. Thorburn, Maria Francesca Donato, Marco Marzioni, Laura Cristoferi, Alessandra Nardi, Deborah D. Stocken, Domenico Alvaro, Vincenzo Ronca, Graeme J.M. Alexander, George F. Mells, A. Floreani, Luigi Muratori, and P.M. Battezzati

Subjects
Oncology, Pre treatment, medicine.medical_specialty, Primary (chemistry), Hepatology, Combination therapy, business.industry, Internal medicine, First line, Risk stratification, medicine, business
Published
2018

14. P.08.3 MULTIPLE PLASTIC STENT (MPS) VERSUS FCSEMS FOR MANAGING POST LIVER TRANSPLANTATION BILIARY STRICTURE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIAL

Author

M. Mutignani, Marcello Cintolo, A. Tringali, Giulia Bonato, Laura Cristoferi, Edoardo Forti, Lorenzo Dioscoridi, and Francesco Pugliese

Subjects
medicine.medical_specialty, Hepatology, business.industry, medicine.medical_treatment, Gastroenterology, Liver transplantation, law.invention, Surgery, Randomized controlled trial, law, Meta-analysis, medicine, Plastic stent, business
Published
2018

18. P.04.21 PSEUDOCYSTS' METAL STENT DRAINAGE: STENT REMOVAL IS NOT MANDATORY

Author

Laura Cristoferi, Edoardo Forti, Francesco Pugliese, A. Tringali, Marcello Cintolo, Giulia Bonato, Lorenzo Dioscoridi, and M. Mutignani

Subjects
medicine.medical_specialty, Hepatology, business.industry, Stent removal, medicine.medical_treatment, Gastroenterology, medicine, Stent, Drainage, business, Surgery
Published
2018

22. V.01.7 A CHALLENGING ESOPHAGEAL FOREIGN BODY

Author

A. Tringali, Marcello Cintolo, D. Falchetti, M. Heinen, Laura Cristoferi, M. Mutignani, Edoardo Forti, Lorenzo Dioscoridi, and Francesco Pugliese

Subjects
medicine.medical_specialty, Hepatology, business.industry, General surgery, Gastroenterology, medicine, Esophageal foreign body, business
Published
2018

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