An Interim Analysis of a Prospective Observational Study of Upadacitinib in Patients with Atopic Dermatitis with Prurigo Nodules

Abstract

A multicenter prospective observational study of upadacitinib, an oral Janus kinase (JAK) inhibitor, in moderate to severe atopic dermatitis patients with prurigo nodularis in the real-world setting (ADMIRE study) has been ongoing since December 2022. This report presents the results of interim analyses of efficacy and safety based on data from 120 patients whose CRFs were fixed as of April 2024. In the analysis population, the mean (SD) age was 33.1 (17.6) years, the Baseline Worst Pruritus Numerical Rating Scale (WP-NRS) was 7.2 (1.9), and the Eczema Area and Severity Index (EASI) was 26.4 (9.4). The proportion of patients who achieved a reduction in WP-NRS ≥ 4 at Week 12, the primary endpoint, was 66.0% (95%CI: 56.0, 75.1). The secondary endpoints of EASI75 and EASI90 response rates at Week 12 were 78.1% (95%CI: 69.0, 85.6) and 53.3% (95%CI: 43.3, 63.1), respectively. The safety profile was similar to that in the overall population in previous clinical trials and post-marketing clinical studies, and no new safety signals were observed.