RESPONSE TO URSODIOL THERAPY IN REDUCING ALKALINE PHOSPHATASE TO NORMAL LEVELS IN PRIMARY BILIARY CHOLANGITIS IN A DIVERSE COMMUNITY PRACTICE

Document Type

Conference Proceeding

Publication Date

11-14-2023

Publication Title

Hepatology

Abstract

Background: Primary biliary cholangitis (PBC) is an autoimmune cholestatic liver disease that can lead to advanced fibrosis and cirrhosis. First-line treatment is ursodiol (UDCA), which decreases hepatic synthesis of cholesterol and desaturates biliary cholesterol. The objective is to assess the effectiveness of UDCA on lowering alkaline phosphatase (ALP) levels in patients diagnosed with PBC. Methods: A retrospective review was conducted at a diverse urban academic center to obtain UDCA dosage and ALP values at the start of UDCA therapy and at 6 and 12 month periods to correlate with long term survival. Covariants such as Fibroscan results and liver transplant status were analyzed followed by chi-squared tests and linear regression analysis. Results: 122 newly-presenting PBC patients were treated only with UDCA. Mean age was 61.6 years old (range 26-90). 73% (n =89) of the patients were females. The mean liver stiffness by Fibroscan evaluation was 9.7 kPa with standard deviation (SD) of 6.65 (n = 47). Results were tiered based on low (<130), medium (130-200) and high (> 200) ALP levels. At baseline, the percentage of patients in low, medium, and high ALP groups were 11%, 36%, and 53%, respectively. After 12 months of treatment, the percentage of patients in low, medium, and high ALP groups were 42%, 33%, and 21%, respectively. Treatment regimen was defined as low dose (<10mg/kg/day, 31%), medium dose (10-15mg/ kg/day, 51%) and high dose ( > 15mg/kg/day, 18%). The mean UDCA dose was 11.7 mg/kg/day (SD 4.44) upon initiation of therapy. Baseline ALP levels in low, medium and high dose UDCA groups was 47%, 53%, and 59%, respectively. ALP > 200 at 12 months in low, medium and high dose UDCA groups was 21%, 18%, and 18%, respectively. Overall 20.9% of patients had ALP >200 after 12 months. 56.5% of patients had ALP >130 at 12 months. The chi-square test showed no significant association between categorical UDCA dose and categorical ALP at 6 and 12 months. Linear regression analysis showed no significant UDCA dose effect on change in ALP from baseline to 6 and 12 months. The 3 and 5 year survival following diagnosis was 96% (n = 117) and 95% (n = 116), respectively. Survival at 3 and 5 years was 100% in those with 12 month ALP < 130, 97.6% and 95.1% in those with 12 month ALP 130-200, and 95.7% in those with 12 month ALP > 200, respectively. In patients with ALP >200 at baseline, 44.4% had a Fibroscan value < 8kpa vs 18.5% had a Fibroscan value > 14 kpa. In patients with ALP > 200 at 12 months, 21.7% had a Fibroscan value < 8kpA vs 0% had a Fibroscan value > 14kpa. Conclusion: Initiating UDCA decreased the number of patients with ALP >200 at 6 and 12 months compared to baseline. UDCA therapy aids survival but failed to reduce ALP levels <200 in 20% of patients. Additional therapies should be considered for these patients.

Volume

78

First Page

S2071

Last Page

S2072

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