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

2022; Wiley; Volume: 42; Issue: 11 Linguagem: Inglês

10.1111/liv.15386

1478-3231

Antonio De Vincentis, Daphne D’Amato, Laura Cristoferi, Alessio Gerussi, Federica Malinverno, Ana Lleò, Francesca Colapietro, Fabio Marra, Andrea Galli, C. Fiorini, B. Coco, Maurizia Brunetto, Grazia Anna Niro, Rosa Cotugno, Carlo Saitta, Raffaele Cozzolongo, Francesco Losito, Edoardo G. Giannini, 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 Romana Ponziani, Annalisa Tortora, F. Rosina, Maurizio Russello, Mariarita Cannavò, Loredana Simone, Silvia Storato, Mauro Viganò, Ludovico Abenavoli, Maria D’Antò, Elisabetta De Gasperi, 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 Terracciani, Giovanni Galati, Vincenzo Ronca, Massimo Zuin, Ernesto Claar, Antonio Izzi, Antonio Picardi, Pietro Invernizzi, Umberto Vespasiani‐Gentilucci, Marco Carbone,

Gallbladder and Bile Duct Disorders

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.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).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.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.