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Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid.
De Vincentis, Antonio; D'Amato, Daphne; Cristoferi, Laura; Gerussi, Alessio; Malinverno, Federica; Lleo, Ana; Colapietro, Francesca; Marra, Fabio; Galli, Andrea; Fiorini, Cecilia; Coco, Barbara; Brunetto, Maurizia; Niro, Grazia Anna; Cotugno, Rosa; Saitta, Carlo; Cozzolongo, Raffaele; Losito, Francesco; Giannini, Edoardo Giovanni; Labanca, Sara; Marzioni, Marco; Marconi, Giulia; Morgando, Anna; Pellicano, Rinaldo; Vanni, Ester; Cazzagon, Nora; Floreani, Annarosa; Chessa, Luchino; Morelli, Olivia; Muratori, Luigi; Pellicelli, Adriano; Pompili, Maurizio; Ponziani, Francesca; Tortora, Annalisa; Rosina, Floriano; Russello, Maurizio; Cannavò, Mariarita; Simone, Loredana; Storato, Silvia; Viganò, Mauro; Abenavoli, Ludovico; D'Antò, Maria; De Gasperi, Elisabetta; Distefano, Marco; Scifo, Gaetano; Zolfino, Teresa; Calvaruso, Vincenza; Cuccorese, Giuseppe; Palitti, Valeria Pace; Sacco, Rodolfo; Bertino, Gaetano.
  • De Vincentis A; Internal Medicine and Hepatology, University Campus Bio-Medico of Rome, Rome, Italy.
  • D'Amato D; Gastroenterology Unit, Città della salute e della scienza, Turin, Italy.
  • Cristoferi L; Division 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.
  • Gerussi A; Division 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.
  • Malinverno F; Division 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.
  • Lleo A; Internal Medicine and Hepatology, Humanitas Clinical and Research Center IRCCS, Humanitas University, Milan, Italy.
  • Colapietro F; Internal Medicine and Hepatology, Humanitas Clinical and Research Center IRCCS, Humanitas University, Milan, Italy.
  • Marra F; Internal Medicine and Hepatology Unit, Department of Experimental and Clinical Medicine, University of Firenze, Firenze, Italy.
  • Galli A; Department of Experimental and Clinical Biochemical Sciences, University of Florence, Florence, Italy.
  • Fiorini C; Department of Experimental and Clinical Biochemical Sciences, University of Florence, Florence, Italy.
  • Coco B; Hepatology Unit, University Hospital of Pisa, Pisa, Italy.
  • Brunetto M; Hepatology Unit, University Hospital of Pisa, Pisa, Italy.
  • Niro GA; Gastroenterology Unit, Fondazione Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Italy.
  • Cotugno R; Gastroenterology Unit, Fondazione Casa Sollievo Della Sofferenza IRCCS, San Giovanni Rotondo, Italy.
  • Saitta C; Division of Medicine and Hepatology, University Hospital of Messina "Policlinico G. Martino", Messina, Italy.
  • Cozzolongo R; Gastroenterology Unit, National Institute of Gastroenterology "S de Bellis" Research Hospital, Castellana Grotte, Italy.
  • Losito F; Gastroenterology Unit, National Institute of Gastroenterology "S de Bellis" Research Hospital, Castellana Grotte, Italy.
  • Giannini EG; Gastroenterology Unit, Department of Internal Medicine, University of Genova, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
  • Labanca S; Gastroenterology Unit, Department of Internal Medicine, University of Genova, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
  • Marzioni M; Clinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy.
  • Marconi G; Clinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy.
  • Morgando A; Gastroenterology Unit, Città della salute e della scienza, Turin, Italy.
  • Pellicano R; Gastroenterology Unit, Città della salute e della scienza, Turin, Italy.
  • Vanni E; Gastroenterology Unit, Città della salute e della scienza, Turin, Italy.
  • Cazzagon N; Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy.
  • Floreani A; Gastroenterology Unit, Department of Surgery, Oncology and Gastroenterology, Padua University Hospital, Padua, Italy.
  • Chessa L; Liver Unit, University Hospital of Cagliari, Cagliari, Italy.
  • Morelli O; Clinic of Gastroenterology and Hepatology, Department of Medicine, Università degli Studi di Perugia, Perugia, Italy.
  • Muratori L; DIMEC Università di Bologna, Policlinico di Sant'Orsola, Bologna, Italy.
  • Pellicelli A; Liver Unit, San Camillo Hospital, Rome, Italy.
  • Pompili M; Internal Medicine and Hepatology Unit, Policlinico Gemelli, Sapienza University, Rome, Italy.
  • Ponziani F; Internal Medicine and Hepatology Unit, Policlinico Gemelli, Sapienza University, Rome, Italy.
  • Tortora A; Internal Medicine and Hepatology Unit, Policlinico Gemelli, Sapienza University, Rome, Italy.
  • Rosina F; Medical Team Torino, Torino, Italy.
  • Russello M; Liver Unit, Arnas Garibaldi, Catania, Italy.
  • Cannavò M; Liver Unit, Arnas Garibaldi, Catania, Italy.
  • Simone L; Department of Gastroenterology, University Hospital Sant'Anna, Ferrara, Italy.
  • Storato S; IRCCS Sacro Cuore Institute Don Calabria, Gastroenterology, Negrar, Italy.
  • Viganò M; Hepatology Unit, San Giuseppe Hospital, Milan, Italy.
  • Abenavoli L; Department of Health Sciences, University "Magna Graecia" of Catanzaro, Italy.
  • D'Antò M; Hepatology Unit, Santa Maria delle Grazie Hospital, Pozzuoli, Italy.
  • De Gasperi E; Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico - Division of Gastroenterology and Hepatology - CRC "A.M. and A. Migliavacca" Center for Liver Disease, Milan, Italy.
  • Distefano M; Department of Infectious Diseases, Umberto I Hospital, Syracuse, Italy.
  • Scifo G; Department of Infectious Diseases, Umberto I Hospital, Syracuse, Italy.
  • Zolfino T; Department of Gastroenterology, Brotzu Hospital, Cagliari, Italy.
  • Calvaruso V; Gastroenterology and Hepatology Unit, University of Palermo, Palermo, Italy.
  • Cuccorese G; Internal Medicine Ospedale "R. Dimiccoli", Barletta, Italy.
  • Palitti VP; Hepatology Unit, Santo Spirito Hospital, Pescara, Italy.
  • Sacco R; Gastroenterology Unit, Ospedali Riuniti, Foggia, Italy.
  • Bertino G; Gastroenterology and Hepatology Unit, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Liver Int ; 42(11): 2453-2465, 2022 11.
Article in English | MEDLINE | ID: covidwho-2063872
ABSTRACT
BACKGROUND &

AIMS:

Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with "advanced cirrhosis" because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy.

METHODS:

Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs).

RESULTS:

One hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had oesophageal varices and 5 had a history of ascites. Thirty-three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42-2.12), INR (1.37, 1.00-1.87), Child-Pugh score (1.79, 1.28-2.50), MELD (1.17, 1.04-1.30) and bilirubin (1.83, 1.11-3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91, 95%CI 1.10-3.36), lower albumin levels (0.18, 0.06-0.51), Child-Pugh score (2.43, 1.50-4.04), history of ascites (3.5, 1.85-6.5) and bilirubin (1.30, 1.05-1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA.

CONCLUSIONS:

An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Liver Cirrhosis, Biliary Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Humans / Male Language: English Journal: Liver Int Journal subject: Gastroenterology Year: 2022 Document Type: Article Affiliation country: Liv.15386

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Liver Cirrhosis, Biliary Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Humans / Male Language: English Journal: Liver Int Journal subject: Gastroenterology Year: 2022 Document Type: Article Affiliation country: Liv.15386