Real-world experience with obeticholic acid in patients with primary biliary cholangitis

Abstract

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Obeticholic Acid Improves Aminotransferases Early during Treatment in Patients with Primary Biliary Cholangitis Not Responding to Ursodeoxycholic Acid: A Study in Clinical Practice

“…All in all, in our study we observed that OCA treatment determined an improvement in cholestasis that was comparable to the one observed in the registration trial, with a significant, progressive decrease in ALP that began early in the course of OCA administration and that was evident and actual throughout the treatment up to 18 months; moreover, the rate of ALP normalization, bearing in minds the limitation related to the small number of patients included, was similar and even better to the one observed in larger, multicenter, real-life studies [23]. The decrease in cholestasis indexes was accompanied by a decrease in markers of immune activation, such as serum IgM, while from the safety point of view both serum albumin and bilirubin-that were normal in almost all patients at enrolment-showed no unexpected deterioration, emphasizing the safety side of the drug.…”

“…As a fact, one-year, add-on treatment with OCA in UDCA non-responders, or monotherapy in UDCA-intolerant patients, was able to decrease ALP levels and normalize serum bilirubin more frequently as compared to placebo [11]. These positive results were replicated in at least three recent, multicenter, reallife studies performed in Canada, Spain and Portugal, and Italy, although the cut-point of observation in these real-life cohorts was at 12 months as in the registration trial [12,13,23].…”

“…Our study undoubtedly has some shortcomings, such as the relatively small cohort, and the fact that drug titration took longer as compared to the registration trial and was adapted to the clinical context, on the basis of the physician in charge of the patient. While the first limitation of this study is inherent to a single-center experience in a rare disease, the latter represents a smoother approach to treatment that might have been attributed to a cautious initial approach to the drug, as also reported in other real-life studies [23]. As a fact, it has to be emphasized that OCA should be adequately titrated in patients with limited liver function so as to avoid the occurrence of side effects [26,27].…”

Value of Liver Function Tests in Cirrhosis

“…Monitoring of ALP and GGT along with aminotransferase is commonly used for initiation and treatment monitoring in patients with PBC and PSC (34). A raised GGT with raised transaminase and a ratio of AST to ALT of 2:1 or more would suggest alcohol related liver disease.…”

Review article: therapeutic aspects of bile acid signalling in the gut‐liver axis

“…171,172 Nonsteroidal FXR agonists seem to exhibit a better side effect profile regarding pruritus 153. However, both steroidal and non-steroidalTA B L E 2Abbreviations: AE, adverse event; ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; c/dACLD, compensated/decompensated advanced chronic liver disease; DM, diabetes mellitus; FGF19, fibroblast growth factor 19; GGT, gamma-glutamyl transferase; NASH, non-alcoholic steatohepatitis; PBC, primary biliary cholangitis; PSC, primary sclerosing cholangitis; RYGB, Roux-en-Y gastric bypass; W, week.…”