OWE-6 Multicentre evaluation of second line therapies in primary biliary cholangitis: UK experience

Introduction Our aim was to compare the effectiveness of second-line therapies in primary biliary cholangitis (PBC), with regards Obeticholic acid (OCA) and non-licensed therapy (fibric acid derivatives; FA) across a nationwide cohort of patients (pts). Method Efficacy and safety data was accrued from 12 centres across the UK. Biochemical parameters are presented relative to the upper limit of normal (ULN). Results Between August 2017-March 2020 we captured data from 457 PBC pts who initiated second-line therapy (n = 349 OCA, 48 bezafibrate, 60 fenofibrate). The OCA group manifest greater ALP values at baseline than those initiating FA therapy (2.9 v 2.3 x ULN; P = 0.001), with a greater proportion being ursodeoxycholic acid non-responders (63.5% vs 45.4%; P = 0.001), cirrhotic (16.5% v 8.3%; p = 0.03), or having an abnormal bilirubin (22.1% v 12%; p = 0.02). At 12mo, the magnitude of ALP reduction was 29.3% and 56.7% in the OCA and FA groups (p < 0.001 between groups), with 2% and 49% of pts attaining normal ALP values (Figure 1). By contrast, 50.8% and 28.1% attained a normal ALT at 12mo (Figure 1). Moreover, 37.3% of the OCA group who had an abnormal bilirubin at baseline normalised values at 12mo (p < 0.05) - bilirubin values did not change significantly in the FA group. 12mo biochemical response rates (Paris criteria) were 71.1% and 83.1% under OCA and FA therapy, respectively (p = 0.141 between groups). In patients with cirrhosis under OCA treatment (n=57), significant reduction in ALP, ALT and bilirubin were observed at 12 mo (p<0.05 for all comparisons), with 61.5% attaining full biochemical response. The number of patients with an elevated bilirubin and/or cirrhosis in the FA group was too small to permit subgroup analysis therein. Escalation in anti-pruritus therapy was observed in 26.1% and 23.2% of pts (P = n.s.). Mild-moderate elevations in liver biochemistry (DILIN classification) were reported in 4.6% and 12.0% of pts under OCA and FA therapy (p < 0.05). Conclusion In this non-randomised study, the magnitude of ALP reduction was greater with FA derivatives, whereas rates of ALT and bilirubin normalisation were more pronounced under OCA. The need for anti-pruritus treatment is similar between groups, although putative rates of drug-induced liver injury appear greater under FA therapy.

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