P36 Non-invasive tests for liver fibrosis are stable in patients with primary biliary cholangitis (PBC) with two years of treatment with elafibranor

Here, we assess the effect of elafibranor on non-invasive tests (NITs) for fibrosis (liver stiffness measurements [LSM] and Enhanced Liver Fibrosis [ELF]) and biochemical markers in patients with PBC in ELATIVE® (NCT04526665) to Week 104; NITs are also stratified by disease stage. Proportions of patients with LSM >8 kPa and >10 kPa and changes ≥0.5 kPa, and ELF ≥7.7 and ≥9.8 and changes ≥0.19, were assessed at visits to Week 104. Changes were assessed in early- and advanced-stage disease; advanced disease defined as baseline LSM >10 kPa and/or advanced fibrosis/cirrhosis on histology. Changes from baseline (CfB) to Week 104 were assessed for alkaline phosphatase (ALP), total bilirubin (TB), albumin (ALB), alanine aminotransferase (ALT), aspartate transaminase (AST) and gamma-glutamyl transferase (GGT). At data cutoff, 48 patients receiving elafibranor had LSM and 41 had ELF from baseline to Week 104. LSM increased and decreased by ≥0.5 kPa in similar proportions of patients across study visits to Week 104 (36.2–40.0% and 42.6–47.9%). A consistent proportion of patients had LSM >8 kPa and >10 kPa from baseline (54.2% and 33.3%) to Week 104 (50.0% and 29.2%). Of 16 patients with LSM >10 kPa at baseline, 6 (37.5%) had LSM ≤10 kPa at Week 104; of 32 with LSM ≤10 kPa at baseline, 4 (12.5%) had LSM >10 kPa at Week 104. ELF increased and decreased by ≥0.19 in similar proportions of patients across visits to Week 104 (24.4–41.5% and 32.5–41.5%). All patients had ELF ≥7.7 at every visit. Comparable proportions of patients had ELF ≥9.8 at baseline and Week 104 (48.8% vs 39.0%). At Week 104, in patients with early-stage disease, LSM increased and decreased by ≥0.5 kPa in 35.5% and 45.2%, and ELF increased and decreased by ≥0.19 in 44.4% and 37.0%. In patients with advanced-stage disease, LSM increased and decreased by ≥0.5 kPa in 47.1% and 52.9%, and ELF increased and decreased by ≥0.19 in 35.7% and 50.0% of patients. Mean CfB at Week 104 in ALP and GGT was −124.0 U/L and −25.1 U/L in patients with LSM data, and −116.9 U/L and −22.8 U/L in patients with ELF data. TB, ALT, AST and ALB were relatively stable in both subsets. Elafibranor was well-tolerated in this subset to Week 104. With two years of elafibranor treatment, predictors of liver fibrosis and key biochemical markers remain stable in patients with PBC, including those with advanced stage disease.

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