Efficacy of dupilumab for the treatment of moderate-to-severe chronic hepatic pruritus: An open-label, single-arm, exploratory study.

Abstract

Pruritus associated with liver disease is often severe and resistant to conventional treatments and most commonly arises from cholestatic conditions of various etiologies. To evaluate the safety and efficacy of dupilumab, an interleukin-4Rα monoclonal antibody antagonist, in treating moderate-to-severe hepatic pruritus. This open-label, interventional pilot study included 9 patients who received a 600-mg loading dose of dupilumab followed by 300 mg every 2 weeks for 18 weeks. Clinical outcomes were assessed using the Pruritus Numerical Rating Scale, 5D itch scale, Verbal Rating Scale, and Chronic Liver Disease Questionnaire at baseline and follow-up visits. By week 18, mean ± SD Pruritus Numerical Rating Scale scores decreased from 8.2 ± 1.7 to 4.0 ± 3.5 compared to baseline values (P = .023). Mean ± SD 5D itch scale scores declined from 19.8 ± 3.5 to 11.4 ± 5.3 (P = .006), with significant reductions in itch duration (P = .02) and intensity (P = .034). Verbal Rating Scale scores improved markedly, with 75% of patients reporting mild or no itch at week 18 compared to 0% at baseline (P = .021). No significant change was observed in Chronic Liver Disease Questionnaire scores, and no liver-related adverse events occurred. The small sample size limits the statistical power to detect differences. Dupilumab demonstrated efficacy and tolerability in reducing moderate-to-severe hepatic pruritus in this small study.