Alkaline Phosphatase Normalization Occurs Less Frequently in Hispanic Patients With Primary Biliary Cholangitis.

BACKGROUND & AIMS: Alkaline phosphatase (ALP) normalization is increasingly recognized as the optimal treatment target in primary biliary cholangitis (PBC). We evaluated racial and ethnic differences in complete biochemical remission (CBR) to ursodeoxycholic acid (UDCA), with a focus on Hispanic populations.

METHODS

We conducted a retrospective study of the East Los Angeles Latinx PBC cohort, which includes predominantly Hispanic patients at the University of Southern California Medical Centers (2006-2022). PBC was defined using the American Association of Liver Disease criteria. Five-year transplant-free survival and decompensation event were estimated using Kaplan-Meier method. CBR, defined as ALP ≤1 × the upper limit of normal at 1 year after UDCA initiation, was assessed using multivariable logistic regression.

RESULTS

Of 427 patients, 96 (22.5%) were non-Hispanic White (NHW) and 331 (77.5%) were non-White, including 282 Hispanic patients. Five-year transplant-free survival and decompensation event did not differ significantly by race and ethnicity. Among UDCA-naive patients (N = 158), median baseline ALP levels were similar between NHW (231 U/L; interquartile range [IQR], 128-565), Hispanic (285 U/L; IQR, 193-464; P = .21), and non-White patients (275 U/L; IQR, 180-443; P = .25). At 1 year, CBR rates were 41.4% in NHW, 13.8% in Hispanic, and 13.2% in non-White patients, corresponding to 69% lower odds of CBR in Hispanic patients (odds ratio, 0.31; 95% confidence interval, 0.10-0.99; P = .048) and 77% lower odds in non-White patients (odds ratio, 0.23; 95% confidence interval, 0.07-0.82; P = .01) after adjusting for covariates.

CONCLUSIONS

Hispanic patients with PBC, and more broadly non-White patients, were significantly less likely than NHW patients to achieve CBR despite comparable baseline ALP levels. As ALP normalization becomes the preferred therapeutic target, addressing barriers to treatment response in underserved populations is essential.