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Patients showed improved liver histology with reductions in K18 serum levels

Children with nonalcoholic fatty liver disease and adults with nonalcoholic steatohepatitis showed improved liver histology in two randomized trials after experiencing decreased serum levels of keratin 18, according to new research data.

Researchers measured keratin 18 (K18) serum levels of stored samples from 152 children with nonalcoholic fatty liver disease (NAFLD) in the TONIC clinical trial and 231 adults with nonalcoholic steatohepatitis from the PIVENS trial to determine any effects that changes in K18 levels may have over time. Liver biopsies were collected from each patient at the beginning of the trials and after 96 weeks.

Data indicated that in adults and children with decreased serum levels of K18, there were significant improvements in liver histology. Adult patients who showed histologic improvement at 96 weeks had decreased K18 levels compared with those without histologic improvement at weeks 16 (193 ± 293 U/L vs. 139 ± 467 U/L; P<.001), 48 (232 ± 360 U/L vs. 113 ± 425 U/L; P<.001) and 96 (269 ± 368 vs. 97 ± 400 U/L; P<.001). Reductions in K18 serum levels were associated with changes in fibrosis stage (P=.05)

Pediatric patients who demonstrated improved histology over those without improvements at weeks 48 (197 ± 467 U/L vs. 47 ± 350 U/L; P=.005) and 96 (206 ± 432 U/L vs. 2 ± 474 U/L; P<.001) also had decreased K18 levels. These patients with decreased K18 levels also showed improvements in fibrosis stage (P=.02).

The decreased serum K18 levels, however, did not predict greater histologic improvement than reductions in alanine aminotransferase levels in children (P=.42) or adults (P=.34).

“By using samples and data from 400 children and adults with well-characterized NAFLD whose liver histology at baseline and at 96 weeks was centrally reviewed in a blinded fashion … this study represents a substantive investigation of longitudinal changes in K18 levels as a surrogate marker for monitoring liver histology in NAFLD,” the researchers concluded.

Disclosure: The researchers report no relevant financial disclosures.