ADHERENCE TO GUIDELINES FOR ALKALINE PHOSPHATASE MONITORING IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS

Document Type

Conference Proceeding

Publication Date

10-1-2022

Publication Title

Hepatology

Abstract

Background: Ursodeoxycholic acid (UDCA) was the only treatment available for primary biliary cholangitis (PBC) until the approval of obeticholic acid (OCA) by the FDA in 2016. AASLD issued PBC management guidelines (2009, updated 2018) that specify alkaline phosphatase (ALP) monitoring at: A) 12 months post-initiation of UDCA therapy to determine treatment response (e.g., ALP≤1.67 x ULN) or eligibility for second line therapy; and B) every 3-6 months thereafter to monitor disease progression. We investigated adherence to recommended ALP monitoring in a cohort of PBC patients under routine care. Methods: Confirmed PBC cases from 7 health systems in the US-based Fibrotic Liver Disease (FOLD) Consortium were included if they were living as of 1 1 2010 with follow-up through 12 2017; index date was defined as the later of 1 1 2010 or PBC diagnosis date. Patient observation was divided into 2 exclusive segments: 1) the first 12 months post-UDCA initiation; 2) >12 months post-UDCA initiation. Patients were censored at time of entry into a clinical trial or liver transplant evaluation receipt, if applicable. Patients with insufficient follow-up were excluded for ALP monitoring analysis. Figure 1 summarizes patient inclusion by time segment. For Segment 1, adherence to ALP monitoring guidelines was calculated as the proportion of patients with an ALP measurement between 11-16 months post-UDCA initiation; for Segment 2, ALP monitoring compliance was defined as the percent of total follow-up time that ALP was measured per 10-month interval (a more liberal 10-month interval was used, rather than 6-month, to allow for real-world circumstances). Results: Of 2912 patients, 883 were included in Segment 1 and 1661 in Segment 2. ALP monitoring adherence was 62% in Segment 1 and 66% in Segment 2. UDCA non-responder rates were 29% in Segment 1 and 32% in Segment 2 (p=0.19). ALP monitoring compliance in Segment 2 was higher among UDCA non-responders than responders. (87.4% vs. 83.7%, p<0.049); 21.8% of patients had no ALP monitoring at all in Segment 2 (0% adherence and UDCA response unknown). Only 4% of UDCA non-responders received 2nd-line therapy after FDA approval. Conclusion: In a PBC cohort with an average of 10 years' follow-up, there were concerning levels of non-adherence to recommended ALP monitoring. Such findings will be further validated using more recent data. (Figure Presented).

Volume

76

First Page

S1022

Last Page

S1023

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