ArticleJHEP reports : innovation in hepatology2021
Real-world experience with obeticholic acid in patients with primary biliary cholangitis.
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Article in JHEP reports : innovation in hepatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 2 of them syntheses that pooled it.
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39citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 2% of its field
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Who cites it
39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 79 citations in OpenAlex.
- Review of Current and Upcoming Second-Line Treatments for Primary Biliary Cholangitis.Digestive diseases and sciences · 2025Pooled it
- Second-Line Treatment for Patients With Primary Biliary Cholangitis: A Systematic Review With Network Meta-Analysis.Liver international : official journal of the International Association for the Study of the Liver · 2025Pooled it
- Qualitative Evaluation of Fatigue and Pruritus Among Patients with Primary Biliary Cholangitis.Advances in therapy · 2026Article
- Clinical Relevance of Bile Acid and Bile Acid-Related Therapy in Liver Cirrhosis: A Review.Advances in therapy · 2026Review
- FXR-YAP signalling maintains biliary epithelial cell identity and preserves liver homeostasis.Nature metabolism · 2026Article
- Non-Response to Obeticholic Acid Is Associated With Heightened Risks of Developing Clinical Events in Primary Biliary Cholangitis.Alimentary pharmacology & therapeutics · 2026Article
- Primary Biliary Cholangitis: Novel and Emerging Therapies.Gastroenterology & hepatology · 2025Article
- Advancing the management of primary biliary cholangitis: From pathogenesis to emerging therapies.World journal of clinical cases · 2025Review
- High biochemical remission rates in patients with primary biliary cholangitis treated with "triple" anticholestatic therapy.Hepatology communications · 2025Article
- Second-Line Therapies in Primary Biliary Cholangitis: A Comparative Review of Obeticholic Acid, Fibrates, Seladelpar, and Elafibranor.Biomedicines · 2025Review
- Assessment of PBC Pruritus From the ITCH-E Study: Quality of Life, Productivity, and Treatment Experiences.Liver international : official journal of the International Association for the Study of the Liver · 2025Article
- Long-term effectiveness, safety, and liver stiffness dynamics of PBC treatment with obeticholic acid in real-world.JHEP reports : innovation in hepatology · 2025Article
- The Treatment of Primary Biliary Cholangitis: Time for Personalized Medicine.Clinical reviews in allergy & immunology · 2025Review
- Effect of rapamycin nanoparticles in an animal model of primary biliary cholangitis.World journal of hepatology · 2025Article
- Quality Measures to Enhance the Management and Treatment of Primary Biliary Cholangitis: A Delphi Consensus Study.Liver international : official journal of the International Association for the Study of the Liver · 2025Article
- Longitudinal Relationship Between Elevated Liver Biochemical Tests and Negative Clinical Outcomes in Primary Biliary Cholangitis: A Population-Based Study.Alimentary pharmacology & therapeutics · 2025Article
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- Article
- Bile acids and incretins as modulators of obesity-associated atherosclerosis.Frontiers in cardiovascular medicine · 2024Review
- The treatment of primary biliary cholangitis: from shadow to light.Therapeutic advances in gastroenterology · 2024Review
Corrections and comments
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Authors and funding
69 authors at 20 institutions in 1 country.
Daphne D'AmatoDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Antonio De VincentisInternal Medicine and Hepatology, University Campus Bio-Medico of Rome, Rome, Italy.
Federica MalinvernoDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Mauro ViganòHepatology Unit, San Giuseppe Hospital, Milan, Italy.
Domenico AlvaroDepartment of Translational and Precision Medicine, University La Sapienza, Rome, Italy.
Maurizio PompiliInternal Medicine and Hepatology Unit, Policlinico Gemelli, Sapienza University, Rome, Italy.
Antonino PicciottoClinic of Gastroenterology, San Martino Hospital, Genoa, Italy.
Valeria Pace PalittiHepatology Unit, Santo Spirito Hospital, Pescara, Italy.
Maurizio RusselloLiver Unit, Arnas Garibaldi, Catania, Italy.
Silvia StoratoIRCCS Sacro Cuore Institute Don Calabria, Gastroenterology, Negrar, Italy.
Marie Graciella PigozziGastroenterology Unit, Spedali Civili Hospital, Brescia, Italy.
Vincenza CalvarusoGastroenterology and Hepatology Unit, University of Palermo, Palermo, Italy.
Elisabetta De GasperiFoundation IRCCS Ca' Granda Ospedale Maggiore Policlinico - Division of Gastroenterology and Hepatology - CRC "A.M. and A. Migliavacca" Center for Liver Disease, Milan, Italy.
Ana LleoInternal Medicine and Hepatology, Humanitas Clinical and Research Center IRCCS, Humanitas University, Milan, Italy.
Antonino CastellanetaGastroenterology Unit, Policlinico di Bari Hospital, Bari, Italy.
Adriano PellicelliLiver Unit, San Camillo Hospital, Rome, Italy.
Nora CazzagonGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy.
Annarosa FloreaniGastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy.
Luigi MuratoriDIMEC Università di Bologna, Policlinico di Sant'Orsola, Via Massarenti 9, 40138, Bologna, Italy.
Stefano FagiuoliHepatology and Liver Transplant Unit, Papa Giovanni XXIII Hospital, Bergamo, Italy.
Grazia Anna NiroGastroenterology Unit, Fondazione Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Foggia, Italy.
Valentina FelettiGastroenterology Unit, Santa Maria Delle Croci Hospital, Ravenna, Italy.
Raffaele CozzolongoGastroenterology Unit, National Institute of Gastroenterology "S de Bellis" Research Hospital, Castellana Grotte, Bari, Italy.
Natalia TerreniHepatology Unit, Valduce Hospital, Como, Italy.
Marco MarzioniClinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy.
Rinaldo PellicanoGastroenterology Unit, Città della salute e della scienza, Turin, Italy.
Pietro PozzoniHepatology Unit, Alessandro Manzoni Hospital, Lecco, Italy.
Leonardo BaiocchiHepatology Unit, University of Rome "Tor Vergata", Rome, Italy.
Luchino ChessaLiver Unit, University Hospital of Cagliari, Cagliari, Italy.
Floriano RosinaMedical Team Torino, Turin, Italy.
Gaetano BertinoGastroenterology and Hepatology Unit, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Maria VinciHepatology Unit, Niguarda Hospital, Milan, Italy.
Anna MorgandoGastroenterology Unit, Città della salute e della scienza, Turin, Italy.
Ester VanniGastroenterology Unit, Città della salute e della scienza, Turin, Italy.
Gaetano ScifoDepartment of Infectious Diseases, Umberto I Hospital, Syracuse, Italy.
Rodolfo SaccoGastroenterology Unit, Ospedali Riuniti, Foggia, Italy.
Maria D'AntòHepatology Unit, Santa Maria delle Grazie Hospital, Pozzuoli, Italy.
Valentina BelliaHepatology Unit, Valtellina e Alto Lario Hospital, Sondrio, Italy.
Roberto BoldizzoniHepatology Unit, Treviglio Caravaggio Hospital, Treviglio, Italy.
Silvia CasellaHepatology Unit, Spedali Civili Gardone Val Trompia, Brescia, Italy.
Barbara OmazziGastroenterology Unit, Guido Salvini Hospital, Rho, Italy.
Guido PoggiOncology Unit, Istituto di Cura Città di Pavia, Pavia, Italy.
Laura CristoferiDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Alessio GerussiDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Vincenzo RoncaDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Rosanna VenereDepartment of Translational and Precision Medicine, University La Sapienza, Rome, Italy.
Francesca PonzianiInternal Medicine and Hepatology Unit, Policlinico Gemelli, Sapienza University, Rome, Italy.
Maria CannavòLiver Unit, Arnas Garibaldi, Catania, Italy.
Alessandro MussettoGastroenterology Unit, Santa Maria Delle Croci Hospital, Ravenna, Italy.
Rosanna FontanaGastroenterology Unit, Fondazione Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Foggia, Italy.
Francesco LositoGastroenterology Unit, National Institute of Gastroenterology "S de Bellis" Research Hospital, Castellana Grotte, Bari, Italy.
Evelise FrazzettoGastroenterology and Hepatology Unit, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Marco DistefanoDepartment of Infectious Diseases, Umberto I Hospital, Syracuse, Italy.
Francesca ColapietroInternal Medicine and Hepatology, Humanitas Clinical and Research Center IRCCS, Humanitas University, Milan, Italy.
Sara LabancaClinic of Gastroenterology, San Martino Hospital, Genoa, Italy.
Giulia MarconiClinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy.
Giuseppe GrassiHepatology Unit, University of Rome "Tor Vergata", Rome, Italy.
Giovanni GalatiInternal Medicine and Hepatology, University Campus Bio-Medico of Rome, Rome, Italy.
Sarah Elizabeth O'DonnellDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Clara MancusoDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Giacomo MulinacciDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Andrea PalermoDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Ernesto ClaarHepatology Unit, Betania Hospital, Naples, Italy.
Antonio IzziDepartment of Infectious Diseases, D. Cotugno Hospital, Naples, Italy.
Antonio PicardiInternal Medicine and Hepatology, University Campus Bio-Medico of Rome, Rome, Italy.
Pietro InvernizziDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Marco CarboneDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), San Gerardo Hospital, Monza, Italy.
Umberto Vespasiani-GentilucciInternal Medicine and Hepatology, University Campus Bio-Medico of Rome, Rome, Italy.
Italian PBC Registry and the Club Epatologi Ospedalieri (CLEO)/Associazione Italiana Gastroenterologi ed Endoscopisti Digestivi Ospedalieri (AIGO) PBC Study Group
University of Milano-Bicocca · ITUniversità Campus Bio-Medico · ITAzienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAgostino Gemelli University Polyclinic · ITAzienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITGastroenterology Hospital "Saverio de Bellis" · ITHumanitas University · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITMarche Polytechnic University · ITOspedale Garibaldi · ITOspedale Policlinico San Martino · ITOspedale "Santa Maria delle Croci" di Ravenna · ITPoliclinico Umberto I · ITSapienza University of Rome · ITUniversity of Padua · ITUniversity of Rome Tor Vergata · IT5T Torino (Italy) · ITAlessandro Manzoni Hospital · ITAzienda Ospedaliera Treviglio · IT
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND &
aimsObeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions.
methodsPatients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to
resultsWe analysed 191 patients until at least 12 months of follow-up. Median age was 57 years, 94% female, 61 (32%) had cirrhosis, 28 (15%) had histologically proven overlap with autoimmune hepatitis (PBC-AIH). At 12 months, significant median reductions of ALP (-32.3%), ALT (-31.4%), and bilirubin (-11.2%) were observed. Response rates were 42.9% according to
conclusionsEffectiveness and safety of OCA under real-world conditions mirror those in the Poise trial. Patients with cirrhosis had lower tolerability. Overlap PBC-AIH showed higher ALT reduction at 6 months compared with patients with pure PBC. LAY SUMMARY: Obeticholic acid (OCA) was shown to be effective in more than one-third of patients not responding to ursodeoxycholic acid in a real-world context in Italy. Patients with cirrhosis had more side effects with OCA, and this led to suspension of the drug in one-third of patients. OCA was also effective in patients who had overlap between autoimmune hepatitis and primary biliary cholangitis.
Indexed as
AIH, autoimmune hepatitisALP, alkaline phosphataseALT, alanine transferaseAMA, antimitochondrial antibodiesANA, antinuclear antibodiesaRR, adjusted risk ratioAST, aspartate transferaseAutoimmunityCholestasisCirrhosisCRFs, case record formsEDC, electronic data captureGGT, gamma-glutamyl transferaseOCA, obeticholic acidOC, Overall cohortOverlap PBC-AIHPBC, primary biliary cholangitisQC, quality controlRCT, randomised controlled trialRR, risk ratioTCC, Treatment Completer CohortTIPS, transjugular intrahepatic portosystemic shuntUDCA, ursodeoxycholic acidULN, upper limit of normal
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