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ELF score may be used to predict transplant-free survival in PSC

Enhanced liver fibrosis score was found to be a useful predictor for transplant-free survival among patients with primary sclerosing cholangitis, according to data published in Hepatology.

“The slow progression of [primary sclerosing cholangitis] from the early manifestations until end-stage liver disease results in difficulties in establishing a robust level of evidence for the benefit of treatment,” the researchers wrote. “Surrogate biomarkers of disease progression and accurately differentiating mild/early from progressive/advanced disease are thus needed both to evaluate new treatment strategies and to provide prognostic information to patients.”

Researchers collected and analyzed serum samples from 305 Norwegian patients with large-duct (primary sclerosing cholangitis) PSC, 96 patients with ulcerative colitis and 100 healthy controls. The PSC patients were divided into two different panels; a derivation panel (n = 167) recruited between 1992 and 2006 and a validation panel (n = 138) recruited between 2008 and 2012.

“We used commercial kits to analyze serum levels of hyaluronic acid, tissue inhibitor of metalloproteinases-1, and propeptide of type III procollagen and calculated [enhanced liver fibrosis] scores by the previously published algorithm,” the researchers wrote.

The researchers also used the ADVIA Centaur XP system (Siemens Healthcare Diagnostics) to validate the analyses of the enhanced liver fibrosis (ELF) tests.

Overall, ELF scores were higher in patients with PSC compared with the other groups.

Kaplan-Meier analysis showed that patients with PSC separated by ELF score tertiles had different transplant-free survival in both panels (P < .001), with higher scores associated with shorter survival. Median transplant-free survival was significantly longer in the lower ELF score tertile compared to the intermediate and high tertiles both in the derivation panel (P < .001) and in the validation panel (P = .006).

“[This] was confirmed in the validation panel stratified by ELF test tertiles,” the researchers wrote.

The ELF test also differentiated between mild and severe disease with an area under the curve (AUROC) of 0.81 (95% CI, 0.73-0.87) and optimal cutoff of 10.6, which had a sensitivity of 70.2% and specificity of 79.1%.

In both the derivation and validation panels, age, age at diagnosis, bilirubin, albumin, aspartate aminotransferase, international normalized ratio, Mayo risk score and ELF score were associated with PSC (P < .05).

Multivariate Cox regression analysis showed ELF score was associated with transplant-free survival independently of the Mayo risk score in both panels (P < .0001). The ELF test was correlated with ultrasound elastography in other assessments.

“We have demonstrated that the ELF score is a potent prognostic marker in PSC and provides incremental information to the Mayo risk score for the prediction of transplant-free survival,” the researchers concluded. “These findings are of major importance given the urgent need for markers of disease stage and disease activity in PSC.” – by Melinda Stevens

Disclosures: Vesterhus reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.