While a liver biopsy is the standard method of diagnosis and disease progression for non-alcoholic steatohepatitis (NASH), the most extreme form of nonalcoholic fatty liver disease (NAFLD), researchers previously demonstrated that a less invasive blood test to determine caspase three-generated cytokeratin 18 fragment levels (a noninvasive biomarker test, CK-18) can predict the incidence and magnitude of NASH.
A study conducted by researchers at the Cleveland Clinic in Ohio validates the utility of this novel biomarker for NASH diagnosis and assessment of disease severity in a large NAFLD population.
As an ancillary study of the NASH National Institute of Health Clinical Research Network (CRN), 178 patients with well-characterized biopsy-proven NAFLD participated in this study. Another 150 age-matched health controls were analyzed to validate the biomarker methodology. The team tested the NAFLD patients’ blood levels for CK-18 fragments, ranging from 68 to 3000 U/L, which were significantly higher than those observed in the 150 healthy controls (average of 45 U/L blood level).
Results reveal that accurately determining CK-18 fragment levels in the blood differentiates NASH from simple steatosis in patients with NAFLD, supporting the potential of this test in clinical practice as a noninvasive NASH biomarker. In addition to finding that CK-18 could work as a marker of NASH, the study showed that for every 50 U/L increase, the likelihood of having definitive NASH (as opposed to simple steatosis) increased by 74 percent.
“Noninvasive tools are urgently needed for the diagnosis and assessment of NASH in patients with NAFLD,” says Ariel Feldstein, M.D., of Cleveland Clinic Foundation, and co-author of this study. “This method of measuring CK-18 fragment levels in the blood may prove to be an effective noninvasive biomarker for the disease that will assist in diagnosis and prompt treatment.”