Alkaline phosphatase, bilirubin predict outcomes in PBC

(HealthDay)—For patients with primary biliary cirrhosis (PBC), levels of alkaline phosphatase and bilirubin predict clinical outcome, according to a meta-analysis published in the December issue of Gastroenterology.

Willem J. Lammers, M.D., from the Erasmus University Medical Center in Rotterdam, Netherlands, and colleagues performed a meta-analysis of individual patient data from 4,845 patients with PBC in 15 cohort studies. The authors examined the correlation between levels of alkaline phosphatase and bilirubin and outcomes.

The researchers found that 1,118 patients reached a clinical end point. 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 (lower levels correlated with longer transplant-free survival). The best prediction of patient outcome was seen for levels of alkaline phosphatase that were 2.0 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 1.0 times the ULN at one year after study enrollment best predicted patient transplant-free survival (C-statistic, 0.79). 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," the authors write.

Several authors disclosed financial ties to the pharmaceutical industry; the study was partially funded by Intercept Pharmaceuticals and Zambon Nederland BV.

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