Dupilumab is efficacious in patients with prurigo nodularis regardless of history of atopic comorbidities: Pooled results from two phase 3 trials (LIBERTY-PN PRIME and PRIME2)

Prurigo nodularis (PN) is a chronic inflammatory skin condition characterized by severely itchy skin nodules. Nearly half of affected adult patients have a history of (or current) atopic comorbidity, such as atopic dermatitis (AD). To report the efficacy of dupilumab in patients with PN with or without history of atopic comorbidities, in a pre-specified analysis of pooled data from two phase 3 trials. In the randomized, double-blind, placebo-controlled, 24-week studies, LIBERTY-PN PRIME (NCT04183335) and PRIME2 (NCT04202679), adults with PN inadequately controlled by topical prescription therapies, were randomized 1:1 to dupilumab 300mg every 2 weeks or matched placebo. Atopic patients were defined as patients with a physician-documented history, or current diagnosis, of at least one of the following atopic comorbidities: AD, allergic rhinitis/rhinoconjunctivitis, asthma, or food allergy. Efficacy was assessed from baseline to Week 24 through the Worst Itch Numerical Rating Scale (WI-NRS; 0–10), and the Investigator's Global Assessment for PN-Stage score (IGA PN-S; 0–4). In total, 311 patients were randomized (dupilumab n=153, atopic/non-atopic n=67/86; placebo, n=158, atopic/non-atopic, n=68/90). At week 24, significantly more atopic and non-atopic dupilumab-treated patients achieved a ≥ 4-point improvement in WI-NRS (58.2/59.3%), and an IGA PN-S score of 0 or 1 (52.2/41.9%) vs. placebo (20.6/17.8% [nominal P