Noninvasive risk scoring system shows promise in predicting PSC progression
Click Here to Manage Email Alerts
SAN DIEGO — The ANALI score, a magnetic resonance-based risk stratification, was associated with baseline markers of liver fibrosis in patients with primary sclerosing cholangitis, with scores linked to risk for clinical events.
“At baseline, ANALI score was associated with noninvasive markers of liver fibrosis and levels of liver enzymes in patients with noncirrhotic PSC,” Michael Trauner, MD, of the Medical University of Vienna, said during a presentation at The Liver Meeting. “Higher baseline ANALI score was associated with an increased incidence of cholangitis events during the PRIMIS study, and the association between ANALI score and other PSC-related clinical events, such as a hepatic decompensation, requires further exploration in future studies with longer follow-up and more patients reaching such endpoints.”
The phase 3 PRIMIS study, which examined the associations between noninvasive markers and ANALI score, enrolled 419 patients aged 18 to 75 years with noncirrhotic primary sclerosing cholangitis (PSC), who were randomly assigned to once-daily cilofexor 100 mg or placebo for 96 weeks. During that time, a central reader analyzed magnetic resonance features and categorical scores.
Trauner and colleagues calculated ANALI score from intrahepatic bile duct dilation, dysmorphy and portal hypertension scores and conducted liver stiffness measurement (LSM) via transient elastography, as well as assessments of enhanced liver fibrosis (ELF), bile acid and liver biochemistry. The ANALI score ranged from 0 to 5.
At baseline, 247 patients had an ANALI score of 2 or less and were considered low-risk for a PSC-related clinical event, while 141 patients had a score of more than 2, considered high-risk.
According to Trauner, ELF score and LSM were significantly associated with increases in baseline ANALI score (both P < .001), while a higher score was not significantly associated with increased levels of liver enzymes or fecal calprotectin.
In addition, baseline ANALI score was significantly associated with cholangitis events (P < .001): Fifteen patients (10.6%) with scores greater than 2 experienced at least one cholangitis event during the study vs. six patients (2.4%) with a score of 2 or less (P < .001).
“ANALI score at baseline was significantly associated with cholangitis events during the study, with an increasing trend for higher percentages of cholangitis in patients with a high ANALI score,” Trauner said. “For example, if you look at patients with an ANALI of 5, 25% developed cholangitis. Of course, we have to be aware the numbers are quite low in this study.”
Trauner explained that the ANALI score seemed to be driven by all three components — intrahepatic bile duct dilation, dysmorphy and portal hypertension — used for its calculation. However, liver dysmorphy was observed in 95% of patients with an ANALI score greater than 2, but it was lacking in 96.4% of patients with an ANALI score of 2 or less.
Trauner also reported a significant association between liver dysmorphy at baseline and increased fibrosis biomarkers and liver enzymes, as well as cholangitis and other clinical events.
“The ANALI score components thereof could become noninvasive biomarkers for usage in PSC trials, in particular in enriching patient populations expected to reach clinical endpoints including cholangitis, and also perhaps as a surrogate parameter in the future,” Trauner said.
Collapse
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. Presented at: The Liver Meeting; Nov. 15-19, 2024; San Diego (hybrid meeting).
Click Here to Manage Email Alerts