The real world use of bezafibrate (bzf) demonstrates it is an effective and well tolerated treatment option for cholestatic itch

Introduction Cholestatic itch is challenging to manage and associated with poor quality of life. The FITCH study demonstrated efficacy for bezafibrate in the reduction of itch symptoms in primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). Our cholestatic itch management algorithm employs bezafibrate after bile acid binding resins. Here we present our real world experience of BZF for itch in a tertiary liver service. Methods All patients prescribed BZF for cholestatic itch between Jan 2022 and April 2023 at a tertiary liver centre were identified from prescribing records. Demographics, clinical data and treatment responses were retrospectively recorded at the time of and 3 months after starting BZF. Differences in laboratory data before and after treatment were compared with Wilcoxon Signed-Rank tests. Results 16 patients were treated with BZF over the study period, 4 patients with PSC, 5 with PBC (one post-liver transplantation (LT)), 2 with PSC-autoimmune hepatitis (AIH) overlap, 2 with PBC-AIH, 2 with biliary stricturing post-LT and 1 with cystic fibrosis associated liver disease. Four patients had cirrhosis. Mean age was 61 years (range 24–76) and patients were started on either 400mg MR OD (10/16) or 200mg IR (6/16). At 3 month follow up 11/16 (69%) reported improvement and 5/16 (31%) unchanged itch. Prior to starting, itch was described as “severe” to “unbearable” in the majority of patients (6–10/10 severity). After three months, in those with improvement, all reported itch scores ≤ 5/10 without additional antipruritic medications. A significant decrease was observed in ALP after 3 months treatment (299 vs 203 IU/L, p = 0.005), but no significant change in ALT (70 vs 60 IU/L, p = 0.09), AST (50 vs 54 IU/L, p = 1), bilirubin (13 vs 10 μmol/L, p 0.85) or other markers of synthetic function. The smallest drop in ALP was observed in patients with PBC, likely due to UDCA treatment leading to lower baseline ALP. A rise in average serum creatinine occurred (69 μmol/L to 77 μmol/L, p = 0.03) but no individual required cessation of BZF. One patient stopped BZF due to diarrhoea and 5 due to lack of efficacy. 1 patient reported erratic blood sugar control, unlikely related to BZF. No episodes of rhabdomyolysis were reported. Conclusions This real world assessment of BZF demonstrates marked improvement in cholestatic itch in over two thirds of patients. BZF is well tolerated and associated with improvement in biochemical markers of cholestasis.