Association of liver biomarker values beyond current thresholds and negative clinical outcomes in primary biliary cholangitis: analysis of a real-world healthcare claims database.
| Title: | Association of liver biomarker values beyond current thresholds and negative clinical outcomes in primary biliary cholangitis: analysis of a real-world healthcare claims database. |
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| Authors: | Ritter TE; GI Alliance Research, 620 E Southlake Blvd, Southlake, TX 76092, USA.; Hanson CJ; South Denver Gastroenterology, 499 E Hampden Ave #420, Englewood, CO 80113, USA.; Fernandes C; Stanford Medicine, Emergency Medicine, 900 Welch Road, Suite 350, Palo Alto, CA 94304, USA.; MacEwan JP; Genesis Research Group, 111 River St Ste 1120, Hoboken, NJ 07030, USA.; Zhao X; Genesis Research Group, 111 River St Ste 1120, Hoboken, NJ 07030, USA.; Parzynski CS; Genesis Research Group, 111 River St Ste 1120, Hoboken, NJ 07030, USA.; Mercer D; Genesis Research Group, 111 River St Ste 1120, Hoboken, NJ 07030, USA.; Ness E; Intercept Pharmaceuticals, 305 Madison Ave, Morristown, NJ 07960, USA.; Wheeler D; Intercept Pharmaceuticals, 305 Madison Ave, Morristown, NJ 07960, USA.; Kowdley KV; Liver Institute Northwest & Elson S. Floyd College of Medicine, Washington State University, 3216 NE 45th Place #212, Seattle, WA 98105, USA.; Mayne T; Intercept Pharmaceuticals, 305 Madison Ave, Morristown, NJ 07960, USA. |
| Source: | Journal of comparative effectiveness research [J Comp Eff Res] 2025 Dec; Vol. 14 (12), pp. e240198. Date of Electronic Publication: 2025 Nov 18. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Becaris Publishing Country of Publication: England NLM ID: 101577308 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2042-6313 (Electronic) Linking ISSN: 20426305 NLM ISO Abbreviation: J Comp Eff Res Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2023- : Royston, UK : Becaris Publishing; Original Publication: London : Future Medicine |
| MeSH Terms: | Liver Cirrhosis, Biliary*/mortality ; Liver Cirrhosis, Biliary*/blood; Biomarkers/blood ; Alkaline Phosphatase/blood ; Alanine Transaminase/blood ; Aspartate Aminotransferases/blood ; Liver Transplantation/statistics & numerical data ; Bilirubin/blood ; Humans ; Female ; Male ; Middle Aged ; Aged ; Databases, Factual ; Proportional Hazards Models ; Longitudinal Studies |
| Abstract: | Aim: To assess the predictive effect of threshold deviations for multiple liver biomarkers on negative clinical outcomes, including hepatic decompensation, liver transplantation, and death in patients with primary biliary cholangitis (PBC) using longitudinal data from a large administrative claims database. Materials & methods: A time-dependent Cox proportional hazards model with time-dependent covariates assessed time to first occurrence of hospitalization for hepatic decompensation, liver transplantation, or death in patients with PBC in the Optum Clinformatics Data Mart™ database. Separate models analyzed proportion of time outside prespecified biomarker thresholds (defined as multiples of upper limit of normal [ULN] for alkaline phosphatase [ALP], total bilirubin [TB], aspartate aminotransferase [AST], and alanine aminotransferase [ALT]; lower limit of normal for albumin). Another model evaluated both ALP and TB with the lowest relevant threshold applied for each biomarker. Results: Overall, 2402 patients were included; 85.3% were female, mean age was 63.3 years, median follow-up was 2.2 years (interquartile range: 1.1-3.9 years). On average, patients had approximately five reported measurements for each biomarker evaluated. Each 10% increase in time outside thresholds was associated with a 6.5%, 9.2%, 9.9%, 7.3% and 23.3% increase in risk of negative outcomes for ALP, TB, AST, ALT and albumin, respectively. Conclusion: In patients with PBC, values outside predefined thresholds for biomarkers including ALP, TB, AST, ALT and albumin strongly predicted negative clinical outcomes. These findings highlight the importance of managing biomarkers beyond ALP in monitoring and the treatment of patients with PBC. |
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| Contributed Indexing: | Keywords: biochemical markers; clinical outcomes; primary biliary cholangitis; real-world data; treatment guidelines; Local Abstract: [plain-language-summary] Why was this study done? Patients with primary biliary cholangitis are at risk of serious health problems if the disease is not treated properly. Certain abnormal liver test results at diagnosis or shortly after starting treatment can help predict these risks. One key liver test often used is alkaline phosphatase. However, it is not known whether regularly tracking liver tests over time or including tests in addition to alkaline phosphatase (aspartate aminotransferase, alanine aminotransferase, total bilirubin and albumin) can better predict who will develop these serious outcomes. What did this study look at? This study used information from health insurance claims to look at whether abnormal liver test results, tracked over time, were linked to negative health problems such as hospitalization for serious liver complications (hepatic decompensation), liver transplantation or death in patients with primary biliary cholangitis. What were the results? Patients who spent more time with abnormal liver test values had a greater risk of serious health problems. The longer they spent outside the normal range, the higher the risk of complications. What do the results mean? It is important to monitor liver test results over time. In addition to ALP, other tests like aspartate aminotransferase, alanine aminotransferase, total bilirubin and albumin also play an important role in evaluating risk. |
| Substance Nomenclature: | 0 (Biomarkers); EC 3.1.3.1 (Alkaline Phosphatase); EC 2.6.1.2 (Alanine Transaminase); EC 2.6.1.1 (Aspartate Aminotransferases); RFM9X3LJ49 (Bilirubin) |
| Entry Date(s): | Date Created: 20251118 Date Completed: 20251203 Latest Revision: 20251207 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC12679663 |
| DOI: | 10.57264/cer-2024-0198 |
| PMID: | 41251604 |
| Database: | MEDLINE |
Journal Article