THE ANALI score, a magnetic resonance-based risk stratification tool, has shown promise in assessing patients with primary sclerosing cholangitis (PSC). It is associated with baseline markers of liver fibrosis and can help predict the risk of clinical events in these patients. According to Michael Trauner from the Medical University of Vienna, the ANALI score correlates with noninvasive markers of liver fibrosis and liver enzyme levels, particularly in noncirrhotic PSC patients.
Presented at the American Association for the Study of Liver Diseases Liver Meeting, the findings from the phase 3 PRIMIS study suggest that the ANALI score can offer insights into PSC progression. The study involved 419 patients, aged 18–75, with noncirrhotic PSC, who were randomly assigned to receive either cilofexor or a placebo over 96 weeks. The study used magnetic resonance imaging to analyse features like intrahepatic bile duct dilation, dysmorphy, and portal hypertension, alongside liver stiffness measurements and enhanced liver fibrosis scores.
At baseline, patients with an ANALI score of 2 or lower were considered at low risk for PSC-related clinical events, while those with a score higher than 2 were classified as high-risk. A significant association was found between a higher baseline ANALI score and an increased incidence of cholangitis events. For instance, 10.6% of patients with a score greater than 2 experienced at least one cholangitis event, compared to only 2.4% of those with a score of 2 or less.
Liver dysmorphy was observed in 95% of patients with a high ANALI score, and it was significantly associated with increased levels of fibrosis biomarkers and liver enzymes. These findings highlight the potential for the ANALI score and its components – such as bile duct dilation, dysmorphy, and portal hypertension – to be used as noninvasive biomarkers in PSC clinical trials. In particular, they may help enrich patient populations expected to reach clinical endpoints, such as cholangitis, and may serve as surrogate markers in future studies.
Reference
Trauner M et al. Associations between biomarkers and magnetic resonance imaging-derived ANALI score in patients with primary sclerosing cholangitis: analysis from the phase 3 PRIMIS study. Presentation 151. AASLD, 15-19 November, 2024.
