Author information

• ¹Departments of Gastroenterology and Hepatology, Henry Ford Health System, and Wayne State University School of Medicine, Detroit, Michigan, USA.
• ²Department of Public Health Sciences, Henry Ford Health System, Detroit, Michigan, USA.
• ³College of Health Solutions, Arizona State University, Phoenix Arizona, USA.
• ⁴University of California Davis School of Medicine, Sacramento, California, USA.
• ⁵Center for Health Research, Kaiser Permanente Mid-Atlantic Research Institute, Rockville, MD.
• ⁶Innovation in Medical Evidence Development and Surveillance, The Reagan-Udall Foundation for the FDA, Washington, District of Columbia, USA.
• ⁷Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.
• ⁸Department of Epidemiology & Health Services Research, Geisinger Clinic, Danville, Pennsylvania, USA.
• ⁹Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, Michigan, USA.
• ¹⁰Essentia Institute of Rural Health, Essentia Health, Duluth, Minnesota, USA.
• ¹¹Palo Alto Medical Foundation Research Institute, Palo Alto, California, USA.
• ¹²Marshfield Clinic Research Foundation, Marshfield, Wisconsin, USA.
• ¹³Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA.
• ¹⁴Center for Health Research, Kaiser Permanente Hawai'i, Honolulu, Hawaii, USA.
• ¹⁵Department of Research and Evaluation, Kaiser Permanente Southern California, Los Angeles, California, USA.
• ¹⁶Baylor, Scott & White Research Institute, Temple, Texas, USA.

Abstract

Background: We used data from the Fibrotic Liver Disease Consortium to evaluate the impact of ursodeoxycholic acid (UDCA) treatment across race/ethnicity, gender, and clinical status among patients with primary biliary cholangitis.

Methods: Data were collected from "index date" (baseline) through December 31, 2016. Inverse Probability of Treatment Weighting was used to adjust for UDCA treatment selection bias. Cox regression, focusing on UDCA-by-risk factor interactions, was used to assess the association between treatment and mortality and liver transplant/death.

Results: Among 4,238 patients with primary biliary cholangitis (13% men; 8% African American, 7% Asian American/American Indian/Pacific Island [ASINPI]; 21% Hispanic), 78% had ever received UDCA. The final multivariable model for mortality retained age, household income, comorbidity score, total bilirubin, albumin, alkaline phosphatase, and interactions of UDCA with race, gender, and aspartate aminotransferase/alanine aminotransferase ≥1.1. Among untreated patients, African Americans and ASINPIs had higher mortality than whites (adjusted hazard ratio [aHR] = 1.34, 95% confidence interval [CI] 1.08-1.67 and aHR = 1.40, 95% CI 1.11-1.76, respectively). Among treated patients, this relationship was reversed (aHR = 0.67, 95% CI 0.51-0.86 and aHR = 0.88, 95% CI 0.67-1.16). Patterns were similar for liver transplant/death. UDCA reduced the risk of liver transplant/death in all patient groups and mortality across all groups except white women with aspartate aminotransferase/alanine aminotransferase ≥1.1. As compared to patients with low-normal bilirubin at baseline (≤0.4 mg/dL), those with high-normal (1.0 > 0.7) and mid-normal bilirubin (0.7 > 0.4) had significantly higher liver transplant/death and all-cause mortality.

Discussion: African American and ASINPI patients who did not receive UDCA had significantly higher mortality than white patients. Among African Americans, treatment was associated with significantly lower mortality. Regardless of UDCA treatment, higher baseline bilirubin, even within the normal range, was associated with increased mortality and liver transplant/death compared with low-normal levels.