Fenofibrate in managing cholestatic pruritus in paediatric patients

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.

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.

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.

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.