Alkaline phosphatase, bilirubin predict outcomes in primary biliary cirrhosis
Several noninvasive endpoints may help predict long-term primary biliary cirrhosis patient outcomes
HealthDay News -- Levels of alkaline phosphatase and bilirubin may predict clinical outcomes in patients with primary biliary cirrhosis, results of a meta-analysis published in Gastroenterology suggest.
“Noninvasive surrogate end points of long-term outcomes of patients with primary biliary cirrhosis (PBC) are needed to monitor disease progression and evaluate potential treatments,” wrote Willem J. Lammers, MD, of the Erasmus University Medical Center in Rotterdam, Netherlands, and colleagues.
To examine the correlation between levels of alkaline phosphatase and bilirubin and outcomes, the researchers performed a meta-analysis of individual patient data from 4,845 patients with PBC in 15 cohort studies.
There was a strong correlation between levels of alkaline phosphatase and bilirubin measured at study enrollment and each year for five years and clinical outcomes — specifically lower levels correlated with longer transplant-free survival.
The best prediction of patient outcome was seen for levels of alkaline phosphatase that were two times the upper limit of normal (ULN) at one year after study enrollment (C-statistic, 0.71), but this was not significantly better than other thresholds.
A bilirubin level one times the ULN at one year after study enrollment best predicted patient transplant-free survival (C-statistic, 0.79). Among patients with bilirubin levels ≤1.0 times the upper limit of normal (ULN), 86% survived for 10 years after study enrollment compared with 41% of those with levels >1.0 times the ULN (P<0.0001), the researchers found.
The ability to predict patient survival times was increased by combining levels of alkaline phosphatase and bilirubin.
"Levels of alkaline phosphatase and bilirubin can predict outcomes (liver transplantation or death) of patients with PBC and might be used as surrogate end points in therapy trials," concluded the investigators.
Several authors disclosed financial ties to the pharmaceutical industry; the study was partially funded by Intercept Pharmaceuticals and Zambon Nederland BV.