Stuart C Gordon1, Kuan-Han Hank Wu2, Keith Lindor3, Christopher L Bowlus4, Carla V Rodriguez5,6, Heather Anderson7, Joseph A Boscarino8, Sheri Trudeau2, Loralee B Rupp9, Irina V Haller10, Robert J Romanelli11, Jeffrey J VanWormer12, Mark A Schmidt13, Yihe G Daida14, Amandeep Sahota15, Jennifer Vincent16, Talan Zhang1, Jia Li1, Mei Lu1. 1. Departments of Gastroenterology and Hepatology, Henry Ford Health System, and Wayne State University School of Medicine, Detroit, Michigan, USA. 2. Department of Public Health Sciences, Henry Ford Health System, Detroit, Michigan, USA. 3. College of Health Solutions, Arizona State University, Phoenix Arizona, USA. 4. University of California Davis School of Medicine, Sacramento, California, USA. 5. Center for Health Research, Kaiser Permanente Mid-Atlantic Research Institute, Rockville, MD. 6. Innovation in Medical Evidence Development and Surveillance, The Reagan-Udall Foundation for the FDA, Washington, District of Columbia, USA. 7. Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA. 8. Department of Epidemiology & Health Services Research, Geisinger Clinic, Danville, Pennsylvania, USA. 9. Center for Health Policy and Health Services Research, Henry Ford Health System, Detroit, Michigan, USA. 10. Essentia Institute of Rural Health, Essentia Health, Duluth, Minnesota, USA. 11. Palo Alto Medical Foundation Research Institute, Palo Alto, California, USA. 12. Marshfield Clinic Research Foundation, Marshfield, Wisconsin, USA. 13. Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA. 14. Center for Health Research, Kaiser Permanente Hawai'i, Honolulu, Hawaii, USA. 15. Department of Research and Evaluation, Kaiser Permanente Southern California, Los Angeles, California, USA. 16. Baylor, 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.
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.
Authors: Jia Li; Mei Lu; Yueren Zhou; Christopher L Bowlus; Keith Lindor; Carla Rodriguez-Watson; Robert J Romanelli; Irina V Haller; Heather Anderson; Jeffrey J VanWormer; Joseph A Boscarino; Mark A Schmidt; Yihe G Daida; Amandeep Sahota; Jennifer Vincent; Kuan-Han Hank Wu; Sheri Trudeau; Loralee B Rupp; Christina Melkonian; Stuart C Gordon Journal: Dig Dis Sci Date: 2021-09-09 Impact factor: 3.487
Authors: Mei Lu; Christopher L Bowlus; Keith Lindor; Carla V Rodriguez-Watson; Robert J Romanelli; Irina V Haller; Heather Anderson; Jeffrey J VanWormer; Joseph A Boscarino; Mark A Schmidt; Yihe G Daida; Amandeep Sahota; Jennifer Vincent; Jia Li; Sheri Trudeau; Loralee B Rupp; Stuart C Gordon Journal: Clin Epidemiol Date: 2020-11-10 Impact factor: 4.790