Fenofibrate in managing cholestatic pruritus in paediatric patients.

Introduction and objectives: Cholestatic pruritus is a difficult-to-manage symptom in cholestatic disorders. This study presents our experience with fenofibrate for treating refractory cholestatic pruritus in paediatric patients.

Materials and methods: We conducted a retrospective review involving patients under 18 with moderate to severe pruritus (5D Itch score >15), unresponsive to conventional treatments. Fenofibrate was administered at 100 mg/20 kg daily, with a maximum dose of 100 mg for those under 20 kg. A good response was defined as a >50% reduction in the 5D Itch score, with partial relief as a 25-50% reduction.

Results: Between May 2017 and May 2023, 25 patients were treated, with a median treatment duration of 24.2 months. Pruritus reduction at 2 weeks, 1, 3, 6, and 12 months was 36.8%, 52.2%, 53.6%, 57.1%, and 60.8%, respectively. After 12 months, 64% (16/25) achieved >50% improvement, and 16% (4/25) showed partial relief. Fenofibrate significantly reduced serum bile acids, AST, ALT, bilirubin, cholesterol, and triglycerides, without affecting elastography. No serious adverse events occurred.

Conclusions: Fenofibrate shows potential in managing pruritus in paediatric patients with cholestatic diseases, warranting further investigation through randomized clinical trials to assess its efficacy and safety.