Abstracts of the 2023 Annual Meeting of the ALEH
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Introduction and ObjectivesPrimary biliary cholangitis (PBC) is a chronic, progressive, autoimmune liver disease characterized by the destruction of the small bile ducts within the liver. Ursodeoxycholic acid (UDCA) is the first-line treatment for PBC, shown to improve liver biochemistry and delay disease progression. However, the response to UDCA therapy is variable among patients, with some failing to achieve a satisfactory biochemical response. Identifying predictors of non-response is crucial for optimizing treatment strategies and improving patient outcomes. Recent evidence has shown a lower biochemical response among patients of Hispanic ethnicity, which is often underrepresented in clinical research. The findings have significant implications for clinical practice, and are of particular interest in countries that have limited access to liver transplantation.
Patients / Materials and MethodsThis is a single center, retrospective, propensity score-matched cohort study, which included all patients with PBC confirmed by liver biopsy that were followed by the hepatology clinic from January 1st, 2015 to March 1st 2024 under treatment with UDCA. A biochemical response was defined according to the Toronto criteria, with an alkaline phosphatase (ALP) <1.67 x ULN after 2 years of UDCA therapy. Patients were subdivided on the presence or absence of a biochemical response. The primary outcome was mortality due to a liver related event (LRE), the secondary outcomes were variables associated with non-response.
Results and DiscussionA total of 132 patients were included, 70 were non responders and 62 fulfilled Toronto criteria of response. The predominant gender was female in both groups (96.78% and 96%) with a median of 56 years of age for the non-responders and 58 years for those who did. Mortality due to LRE in the no response vs responders group was 41% vs 6.2%, respectively, a difference which was statistically significant (OR 3.67, 95% CI [1.608, 8.411], p<0.001). Factors associated with incomplete response were statistically significant for a baseline level of ALP > 2 x ULN (OR 5.3, 95% CI [2.433, 11.649], p<0.001), a baseline level of ALT > ULN (OR 5.3, 95% CI [2.429, 11.845], p<0.001) and a baseline level of AST > ULN (OR 7.8, 95% CI [3.554, 17.159] p<0.001). All of these variables remained ss after multivariate regression analysis.
ConclusionsAmong patients with PBC that receive initial therapy with UDCA, a baseline increased ALP, AST and ALT are associated with an incomplete biochemical response, identifying patients that might benefit from early initiation of additional therapies. Prospective studies are needed.