Document Type

Article

Publication Date

2026

Comments

This article is the author's final published version in Future rare Diseases, Volume 6, Issue 1, 2026, Article Number 2664390.

The published version is available at https://doi.org/10.1080/23995270.2026.2664390. Copyright © 2026 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

Abstract

Prurigo nodularis (PN) is a chronic, intensely pruritic dermatosis driven by neural and immune dysregulation, with historically limited FDA-approved treatment options. In September 2022, dupilumab became the first FDA-approved therapy for PN. To review the clinical efficacy of dupilumab in PN, with emphasis on pivotal clinical trials, real-world evidence, and safety profile. We examined mechanistic studies of dupilumab, early case reports and series, phase 3 LIBERTY-PN PRIME and PRIME2 randomized trials, real world observational studies, and safety data. Dupilumab, a human monoclonal antibody targeting IL-4Rα, suppresses type 2 inflammation. In PRIME (n = 151) and PRIME2 (n = 160), dupilumab significantly outperformed placebo in achieving ≥4-point reductions in WI-NRS and IGA PN-S 0/1 lesion clearance. Pooled analyses confirmed early onset of itch relief by week 3 and consistent efficacy across atopic status and racial subgroups. Real-world cohorts (n = 73) demonstrated ≥ 4-point PP-NRS reductions in 84.9% of patients by week 12, and long-term data (up to 104 weeks) indicate sustained response. Dupilumab demonstrates a favorable safety profile, with low rates of serious adverse events. Dupilumab offers a well-tolerated and effective treatment for PN, delivering rapid itch relief, lesion clearance, and quality-of-life improvements.

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Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

Language

English

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