•LSM improved prediction of survival beyond established biochemical response criteria and prognostic scores in >3,000 patients with PBC.•The thresholds of 8 kPa and 15 kPa optimally discriminated patients into low, medium, and high-risk groups.•Forty percent of patients were at medium to high risk of poor clinical outcomes according to these thresholds.•LSM by VCTE is a major, validated prognostic marker of PBC whose potential as a surrogate endpoint should be considered.
