Prognostic Performance of Liver Stiffness Measurements in Primary Sclerosing Cholangitis: The Prospective FICUS cohort.

BACKGROUND & AIMS: Predicting outcomes of primary sclerosing cholangitis (PSC) by reliable and simple tools is an unmet need. Retrospective studies have suggested that liver stiffness measurement (LSM) by vibration-controlled transient elastography (FibroScan, Echosens) can predict outcomes. We aimed to validate the prognostic value of LSM statics and determine the relevance of LSM dynamics in a large, prospective, cohort study.

METHODS

Clinical, biological, and LSM data of adult patients with uncomplicated PSC were prospectively recorded annually for 5 years. LSM was assessed continuously or according to 3 Baveno VII classes (<10 kPa, ≥10 to <15 kPa, and ≥15 kPa). The primary end point was transplant-free survival. Adjusted hazard ratios and 95% confidence intervals were determined using time-dependent multivariable Cox regression analyses. Effect of LSM change was evaluated using joint modeling. Progression was defined by a significantly positive individual LSM slope.

RESULTS

The study analyzed 538 patients with at least 1 reliable LSM and follow-up available (median, 60.7 months; interquartile range [IQR], 48.6-66.0 months). Median baseline LSM was 7.6 kPa (IQR, 5.8-11.7 kPa). Nineteen patients died, and 72 received a transplant. Baseline LSM was strongly and independently linked to the risk of death or transplantation. For the groups 2.5 to <10 kPa, 10 to <15 kPa, and ≥15 kPa, the 5-year transplant-free survival was 93.9% (IQR, 90.3%-96.2%), 78.1% (IQR, 66.2%-86.3%), and 46.0% (IQR, 34.6%-56.7%), respectively. Progressors experienced worse transplant-free survival vs nonprogressors: adjusted hazard ratio of 3.12 (95% confidence interval, 1.55-6.24; P = .001). Each 1-kPa/y increment was associated with 18% increase in risk of death or transplantation.

CONCLUSIONS

This observational study validates the strong prognostic value of both static and dynamic LSM in PSC, as assessed by FibroScan. These results support the use of LSM as a risk stratification tool and potential surrogate end point in clinical trials.