Future Rare Diseases · Available online 7 Jun 2026 · In press · DOI 10.1080/23995270.2026.2664390
Iain Noel Encarnacion, Noelle Desir, Simona A. Alomary, Nicole J. Baker, Nicholas Mollanazar
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.
Abstract from DOAJ. Public domain (CC0 1.0).
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Encarnacion, I., Desir, N., Alomary, S., et al. (2026). Dupilumab for the treatment of prurigo nodularis. Future Rare Diseases. https://doi.org/10.1080/23995270.2026.2664390