Predictors of serious adverse events and non‐response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid

• DOI: 10.1111/liv.15386
• Publication Date: 2022-08-06T03:53:06Z
• Authors: Antonio De Vincentis; Daphne D'Amato; Laura Cristoferi; Alessio Gerussi; Federica Malinverno; Ana Lleo; Francesca Colapietro; Fabio Marra; Andrea Galli; Cecilia Fiorini; Barbara Coco; Maurizia Brunetto; Grazia Anna Niro; Rosa Cotugno; Carlo Saitta; Raffaele Cozzolongo; Francesco Losito; Edoardo Giovanni ...; Sara Labanca; Marco Marzioni; Giulia Marconi; Anna Morgando; Rinaldo Pellicano; Ester Vanni; Nora Cazzagon; Annarosa Floreani; Luchino Chessa; Olivia Morelli; Luigi Muratori; Adriano Pellicelli; Maurizio Pompili; Francesca Ponziani; Annalisa Tortora; Floriano Rosina; Maurizio Russello; Mariarita Cannavò; Loredana Simone; Silvia Storato; Mauro Viganò; Ludovico Abenavoli; Maria D'Antò; Elisabetta De Gas...; Marco Distefano; Gaetano Scifo; Teresa Zolfino; Vincenza Calvaruso; Giuseppe Cuccorese; Valeria Pace Palitti; Rodolfo Sacco; Gaetano Bertino; Evelise Frazzetto; Domenico Alvaro; Giacomo Mulinacci; Andrea Palermo; Miki Scaravaglio; Francesca Terracc...; Giovanni Galati; Vincenzo Ronca; Massimo Zuin; Ernesto Claar; Antonio Izzi; Antonio Picardi; Pietro Invernizzi; Umberto Vespasian...; Marco Carbone
• Keywords: Obeticholic acid; Primary Biliary Cirrhosis

Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) "advanced cirrhosis" because of its narrow therapeutic index. We aimed to better define the predicting factors hepatic serious adverse events (SAEs) and non-response cirrhotic undergoing OCA therapy.Safety efficacy treatment were evaluated a cohort consecutive PBC started OCA. response was according Poise criteria. Risk for SAEs reported as risk ratios (RR) 95% confidence intervals (CIs).One hundred cirrhotics included, 97 Child-Pugh class A 3 B. Thirty-one had oesophageal varices 5 history ascites. Thirty-three per cent 32% achieved biochemical at 6 12 months respectively. Male sex (adjusted-RR 1.75, 95%CI 1.42-2.12), INR (1.37, 1.00-1.87), score (1.79, 1.28-2.50), MELD (1.17, 1.04-1.30) bilirubin (1.83, 1.11-3.01) independently associated Twenty-two discontinued within months: 10 pruritus, 9 (5 jaundice and/or ascitic decompensation; 4 upper digestive bleeding). 1.91, 1.10-3.36), lower albumin levels (0.18, 0.06-0.51), (2.43, 1.50-4.04), ascites (3.5, 1.85-6.5) (1.30, 1.05-1.56), SAEs. total bilirubin≥1.4 mg/dl baseline most accurate predictor under OCA.An assessment is crucial select who can benefit from Although effective one third cirrhotics, level ≥1.4 should discourage use.