DUPILUMAB has demonstrated significant and clinically meaningful improvements in disease activity and severity among patients with prurigo nodularis (PN), according to a new post hoc analysis of pooled data from the Phase III PRIME and PRIME2 trials.
PN is a chronic dermatological condition characterised by intensely pruritic nodules that can substantially impair quality of life. In these trials, investigators used the Prurigo Activity and Severity (PAS) score, a clinician-reported outcome measure, to assess treatment response. The PAS scoring algorithm incorporated lesion count, the proportion of lesions with excoriations or crusts, and the extent of healed lesions, generating a composite score ranging from 0 to 11.
Dupilumab Delivers Clinically Meaningful Improvements in Prurigo Nodularis
At 24 weeks, dupilumab-treated patients experienced a significantly greater reduction in PAS score compared with placebo, with an absolute least squares mean difference of –2.7 (95% CI: –3.3 to –2.1; p<0.0001). Importantly, this translated into a markedly higher proportion of patients achieving a clinically meaningful response, defined as a ≥3-point reduction in PAS score. Nearly 70% of patients receiving dupilumab met this threshold, compared with just over a quarter of those on placebo (69.3% versus 27.2%; p<0.0001).
Further analysis of individual PAS components reinforced these findings. A significantly greater proportion of patients treated with dupilumab achieved ≤25% of lesions with excoriations or crusting (71.2% versus 30.4%; odds ratio [OR]: 6.2; p<0.0001). Similarly, more than half of dupilumab-treated patients reached ≥75% healed lesions, compared with fewer than one in five in the placebo group (56.2% versus 18.4%; OR: 5.9; p<0.0001).
Findings Reinforce Dupilumab’s Role in Managing Chronic Itch Disorders
These results highlight dupilumab’s robust effect not only on overall disease severity but also on key clinical features associated with disease burden and healing. The authors conclude that improvements observed in PAS scores are both statistically significant and clinically meaningful, supporting dupilumab as an effective therapeutic option for patients with PN.
This analysis provides further evidence for the role of targeted biologic therapy in managing difficult-to-treat inflammatory skin diseases, particularly those driven by chronic itch and skin barrier disruption.
Reference
Stander S et al. Dupilumab Improves Prurigo Activity and Severity in Patients with Prurigo Nodularis: A Post Hoc Analysis of Pooled Results from the PRIME and PRIME2 Trials. Dermatol Ther (Heidelb). 2026. DOI: 10.1007/s13555-026-01692-3
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