Trends of Primary Biliary Cholangitis Among Hospitalized Patients in the United States Between 2011-2020: A Nationwide Cohort Analysis

Introduction: Primary biliary cholangitis (PBC) is an autoimmune liver disease that results in the progressive destruction of the intrahepatic bile ducts and can lead to liver cirrhosis. There is limited data on PBC trends and outcomes in the US. With the increasing accessibility of PBC medications and the approval of new agents for PBC management, we aimed to investigate recent PBC trends and its outcomes among hospitalized patients in the US. Methods: We performed a retrospective study using the National Inpatient Sample database between 2011-2020 of all adult hospitalized patients with discharge diagnoses of PBC. The rates of different PBC-related complications were calculated and stratified by sex. Sex-specific time-trends were estimated using Joinpoint Regression Software (v4.9.0.1, NCI), which uses Monte Carlo permutation analysis to generate the simplest segmented line that reflects change of a variable over time. The trends were reported as annual percentage change (APC) and average APC (AAPC). Results: Between 2011-2020, there were 123,074 hospitalized patients with a diagnosis of PBC. The AAPC of PBC incidence, mortality, and length of stay were stable in men and women (P-values=NS) (Table 1 and Figure 1). While total charges were stable in men (AAPC=2.28; P=0.18), they were increasing in women (AAPC=2.55; P=0.004). When evaluating complications, while the rate of decompensated cirrhosis was decreasing during the entire period, the rates of decompensated cirrhosis started to decrease in 2015 for men (AAPC=-43.49; P=0.002) and 2014 for women (AAPC=-37.48; P=0.02). On the other hand, the rate of patients with gastroesophageal varices (Men AAPC=2.58; P=0.001, Women AAPC=2.83; P=0.004) and portal hypertension (Men AAPC=2.27; P=0.02, Women AAPC=3.64; P< 0.001) was increasing in both sexes. Lastly, the rates of ascites and Sjogren’s Syndrome, and the total charges have been stable in men (P-values=NS) but increasing in women (AAPC= 3.20, 4.33, and 2.55, respectively, P-values< 0.05). Conclusion: Our nationwide study evaluating recent trends and outcomes of PBC shows that the rates of cirrhosis have been decreasing among patients with PBC over the last years which can reflect the improvement in management modalities. We also show that women with history of PBC have been experiencing increasing rates of ascites, Sjogren’s Syndrome, and total charges, compared to men. Future studies are warranted to investigate risk factors associated with the revealed findings.Figure 1.: Trends in Primary Biliary Cholangitis (PBC) related hospitalizations in the US stratified by sex. Table 1. - Joinpoint time-trend analysis of Primary Biliary Cholangitis (PBC) and its outcomes among hospitalized patients in the US between 2011-2020 stratified by sex Sex Time-trends Time period APC (95% CI) AAPC (95% CI) Incidence Men 2011-2020 0.87 (-2.82 to 4.70); P=0.60 0.87 (-2.82 to 4.70); P=0.60 Women 2011-2020 1.24 (-0.15 to 2.64); P=0.07 1.24 (-0.15 to 2.64); P=0.07 Mortality Men 2011-2020 1.06 (-5.97 to 8.63); P=0.74 1.06 (-5.97 to 8.63); P=0.74 Women 2011-2020 0.52 (-2.23 to 3.35); P=0.67 0.52 (-2.23 to 3.35); P=0.67 Length of stay Men 2011-2020 0.15 (-2.60 to 2.97); P=0.91 0.15 (-2.60 to 2.97); P=0.91 Women 2011-2020 0.45 (-0.13 to 1.04); P=0.11 0.45 (-0.13 to 1.04); P=0.11 Total hospital charges Men 2011-2020 2.28 (-1.28 to 5.97); P=0.18 2.28 (-1.28 to 5.97); P=0.18 Women 2011-2020 2.55 (0.77 to 4.37); P=0.004 2.55 (0.77 to 4.37); P=0.004 Cmpensated cirrhosis Men 2011-2015 4.73 (-4.17 to 14.45); P=0.23 -25.66 (-33.13 to -17.35); P< 0.001 2015-2020 -43.49 (-55.54 to -28.17); P=0.002 Women 2011-2014 32.06 (-38.82 to 185.05); P=0.39 -20.09 (-38.72 to 4.19 to -1.66); P=0.09 2014-2020 -37.84 (-56.33 to -11.53); P=0.02 Decompensated cirrhosis Men 2011-2020 -5.52 (-8.79 to -2.12); P=0.005 -7.74 (-11.14 to -4.22); P< 0.001 Men 2011-2020 -6.48 (-9.73 to -3.12); P=0.002 -4.78 (-19.87 to 13.16); P=0.578 Gastroesophageal varices Men 2011-2020 2.58 (0.71 to 4.49); P=0.01 2.58 (0.71 to 4.49); P=0.01 Women 2011-2020 2.83 (1.12 to 4.56); P=0.004 2.83 (1.12 to 4.56); P=0.004 Portal hypertension Men 2011-2020 2.27 (0.40 to 4.17); P=0.02 2.27 (0.40 to 4.17); P=0.02 Women 2011-2020 3.64 (2.33 to 4.97); P< 0.001 3.64 (2.33 to 4.97); P< 0.001 Ascites Men 2011-2018 4.31 (0.55 to 8.20); P=0.03 -0.86 (-4.58 to 3.01); P=0.65 2018-2020 -17.00 (-31.10 to -0.02); P=0.05 Women 2011-2020 3.20 (1.83 to 4.59); P< 0.001 3.20 (1.83 to 4.59); P< 0.001 Sjogren’s syndrome Men 2011-2020 -1.26 (-13.08 to 12.16); P=0.82 -1.26 (-13.08 to 12.16); P=0.82 Women 2011-2020 4.33 (1.20 to 7.55); P=0.01 4.33 (1.20 to 7.55); P=0.01 Hepatocellular carcinoma Men 2011-2020 1.30 (-4.67 to 7.64); P=0.63 1.30 (-4.67 to 7.64); P=0.63 Women 2011-2020 4.99 (-0.21 to 10.47); P=0.05 4.99 (-0.21 to 10.47); P=0.05 Scleroderma Men 2011-2020 -4.75 (-14.94 to 6.67); P=0.35 -4.75 (-14.94 to 6.67); P=0.35 Women 2011-2020 1.46 (-2.32 to 5.38); P=0.40 1.46 (-2.32 to 5.38); P=0.40 Trends are reported as annual percentage change (APC) and average APC (AAPC).