Steatotic Liver Disease Classification Is Dynamic, Affecting Clinical Trial Eligibility and Subclass-Specific...

Steatotic liver disease (SLD) includes the subclasses metabolic-dysfunction-associated steatotic liver disease, metabolic and alcohol-related liver disease, and alcohol-related liver disease. We investigated the robustness of the SLD diagnoses after 2 years.

We performed a prospective cohort study among individuals from the general population and individuals at risk of SLD. Participants were classified according to the diagnostic criteria of the SLD nomenclature at baseline and after 2 years.

We included 1042 participants, mean age was 57 ± 10 years, 663 were male (64%) and 379 (36%) female, and 70 (7%) had advanced fibrosis. At baseline, 595 (57%) had SLD, hereof 371 (62%) met the criteria for metabolic-dysfunction-associated steatotic liver disease, 140 (24%) for metabolic and alcohol-related liver disease, and 83 (14%) for alcohol-related liver disease, and 1 (<1%) was classified as cryptogenic SLD. Median time between the baseline and follow-up visit was 25 months (interquartile range, 24-31). Overall, 399 (38%) of the 1042 participants changed SLD classification from baseline to follow-up. In the group without SLD at baseline, 25% had SLD at follow-up. In comparison, 38% with metabolic-dysfunction-associated steatotic liver disease at baseline were classified differently at follow-up, whereas 62% and 69% of participants with baseline metabolic and alcohol-related liver disease and alcohol-related liver disease were classified differently at follow-up. The primary reasons for changing classification were that individuals no longer met the criteria for having SLD or had altered their alcohol intake.

SLD and the subclassification hereof is highly dynamic, especially driven by changes in alcohol use and hepatic steatosis. This affects eligibility for clinical trials and clinical management of patients with SLD.