Prospective validation of ELF test confirms utility in PSC surveillance

CHICAGO — The Enhanced Liver Fibrosis test predicted increased risk of clinical events and progression to cirrhosis in patients with primary sclerosing cholangitis, according to a presentation at Digestive Disease Week.

“A higher baseline ELF score and a greater change over 12 weeks predicted PSC-related clinical events and progression to cirrhosis in this cohort of PSC patients in a clinical trial,” Christopher L. Bowlus, MD, from the University of California at Davis, Sacramento, said in his presentation. “These prospective data support the potential utility of ELF score, as a noninvasive surrogate endpoint for use in clinical trials of patients with PSC.”

The researchers utilized the cohorts of a recent clinical trial for simtuzumab to validate their theory. The study comprised 234 patients with PSC. Median age was 45 years (range, 37-52 years), 64% were men, 48% had ulcerative colitis, 61.5% were receiving ursodeoxycholic acid therapy and median alkaline phosphatase was 260 U/L (range, 129-401 U/L).

Researchers scored patients with ELF at baseline and every 12 weeks for 96 weeks. At baseline, 94 patients had bridging fibrosis and 25 had cirrhosis. At week 96, 44 patients developed PSC-related clinical events including ascending cholangitis (n = 26), jaundice (n = 8), cholangiocarcinoma (n = 3), ascites (n = 2), encephalopathy (n = 2), variceal hemorrhage (n = 2) and sepsis (n = 1). Additionally, at 96 weeks, 30 patients progressed to biopsy-proven cirrhosis.

Median baseline ELF score in patients who experienced a clinical event was 10.32 (range, 9.69-10.97) compared with a score of 9.2 (8.49-10.13) in patients with no events. Risk of developing a clinical event increased in patients with a higher ELF score at baseline (HR = 1.8; 95% CI, 1.43-2.26) and greater change in ELF at 12 weeks (HR = 4.89; 95% CI, 2.67-9.96).

Risk of clinical events was also increased in patients with a baseline ELF score of 9.8 or greater compared with patients with a baseline ELF score less than 9.8 (P < .001). Similarly, higher baseline ELF scores predicted progression to cirrhosis (OR = 3; 95% CI, 1.97-4.57) as well as significant change at 12 weeks (OR = 3.04; 95% CI, 1.27-7.28). – by Talitha Bennett

References:

Bowlus CL, et al. Abstract 501. Presented at: Digestive Disease Week; May 6-9, 2017; Chicago.

Disclosure: Bowlus reports no relevant financial disclosures.