Dupilumab Improves Prurigo Activity and Severity in Patients with Prurigo Nodularis: A Post Hoc Analysis of Pooled Results from the PRIME and PRIME2 Trials

Prurigo nodularis (PN) is a dermatological condition characterized by intensely itchy nodules. The Prurigo Activity and Severity (PAS) assessment tool is a clinician-reported questionnaire used in the phase 3 dupilumab trials. This post hoc analysis of pooled data from the PRIME (NCT04183335) and PRIME2 (NCT04202679) phase 3 clinical trials evaluated the effect of dupilumab on PAS score using a scoring algorithm based on items 2 (number of pruriginous lesions), 5a (percentage of pruriginous lesions with excoriations/crusts), and 5b (percentage of healed lesions). The mean change from baseline in PAS score (range: 0–11, with higher scores indicating greater severity) and the responder rates based on a clinically meaningful threshold (3.0 points) were compared between groups at week 24. The proportion of patients achieving ≤ 25% lesions with excoriations/crusts (PAS 5a) and the proportion of patients with ≥ 75% healed lesions (PAS 5b) were also analyzed to put the responder analyses in perspective. Dupilumab showed significantly greater reduction versus placebo in mean change in PAS score from baseline to week 24 (absolute least squares [LS] mean difference: –2.7, 95% confidence interval [CI] [–3.3, –2.1]; P < 0.0001). PAS responder rate was significantly higher with dupilumab versus placebo (69.3% versus 27.2%, P < 0.0001). At week 24, significantly higher proportions of dupilumab-treated patients compared with placebo achieved both ≤ 25% lesions with excoriations/crusts (PAS 5a; 71.2% versus 30.4%; odds ratio [OR]: 6.2 [3.6, 10.8], P < 0.0001) and ≥ 75% healed lesions (PAS 5b; 56.2% versus 18.4%; OR: 5.9 [3.3, 10.4], P < 0.0001). This evidence shows that the effect of dupilumab on PAS score is significant and clinically meaningful to patients. Trial registration: ClinicalTrials. gov identifier; PRIME NCT04183335, PRIME2 NCT04202679.