6533b7d3fe1ef96bd1260217
RESEARCH PRODUCT
Predictors of serious adverse events and non-response in cirrhotic patients with primary biliary cholangitis treated with obeticholic acid
A De VincentisD D'amatoL CristoferiA GerussiF MalinvernoA LleoF ColapietroF MarraA GalliC FioriniB CocoM BrunettoGa NiroR CotugnoC SaittaR CozzolongoF LositoEg GianniniS LabancaM MarzioniG MarconiA MorgandoR PellicanoE VanniN CazzagonA FloreaniL ChessaO MorelliL MuratoriA PellicelliM PompiliF PonzianiA TortoraF RosinaM RusselloM CannavoL SimoneS StoratoM ViganoL AbenavoliM D'antoE De GasperiM DistefanoG ScifoT ZolfinoV CalvarusoG CuccoreseVp PalittiR SaccoG BertinoE FrazzettoD AlvaroG MulinacciA PalermoM ScaravaglioF TerraccianiG GalatiV RoncaM ZuinE ClaarA IzziA PicardiP InvernizziU Vespasiani-gentilucciM CarboneV FelettiA MussettoR VenereG BernaccioniM Graciella PigozziS FagiuoliN TerreniP PozzoniL BaiocchiG GrassiM VinciV BelliaR BoldizzoniS CasellaB OmazziG Poggisubject
Liver CirrhosisMaleliver decompensationsafetyHepatologyLiver Cirrhosis Biliarydecision curve analysis; efficacy; liver decompensation; safety; total bilirubin; Albumins; Ascites; Bilirubin; Chenodeoxycholic Acid; Humans; Liver Cirrhosis; Male; Liver Cirrhosis BiliaryBiliaryefficacyAscitesBilirubinChenodeoxycholic Acidtotal bilirubindecision curve analysiSettore MED/12AlbuminsHumansdecision curve analysisdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2022-01-01 |