Abstract
Atopic dermatitis (AD) is a relapsing disease affecting 4.9% of the US population and is characterized by intense pruritus that can lead to eczematous lesions in varying severity. EPIONE was a randomized, double-blind, placebo-controlled study in adults with chronic pruritus associated with AD. Participants were men and women (18-70 years), who were refractory to treatment, had a ≥ 7 average daily pruritus intensity by the Worst Itch Numerical Rating Scale (WI-NRS), and ≥ 1% body surface area of AD. All enrolled patients (N = 375) were randomly assigned to twice-daily placebo (n = 187) or tradipitant (n = 188) for 8 weeks. EPIONE did not meet its primary endpoint of mean improvement in WI-NRS (baseline to Week 8) (P = .567). However, robust antipruritic effect was observed in mild AD patients (rated 1 or 2 at baseline by the validated Investigator Global Assessment for Atopic Dermatitis, P = .015). This result was confirmed by daily diary (P = .001) and observed after one full day of treatment (P = .0457). During 8 weeks of treatment, tradipitant was well-tolerated by all participants and although worst itch was not improved over placebo in the overall study population, there was a large and rapid antipruritic effect in the subset of patients with mild AD. These data support the role of neurokinin-1 antagonism in chronic pruritus related to mild AD. Tradipitant may represent a new oral systemic option for mild AD patients based on the well-tolerated safety profile and immediate robust improvement in itch.
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