386 Complete/near-complete itch response observed in adult and adolescent patients with moderate-to-severe atopic dermatitis initiating dupilumab treatment in real-world practice

Abstract

Abstract Chronic itch (pruritus) is a defining characteristic of atopic dermatitis (AD) and is a significant contributor to poor quality of life in patients. A Pruritus/Peak Pruritus Numerical Rating Scale (NRS) score of 0/1 could be considered a complete or near-complete itch response. This study aims to report Pruritus NRS and Overall Disease Severity (ODS) score of 0/1 over time in patients older than 12 years with moderate-to-severe AD initiating dupilumab treatment in real-world practice. Patients aged ≥12 years with moderate-to-severe AD, initiating real-world dupilumab treatment for AD per approved prescribing information in the USA and Canada, were eligible for entry into PROSE (NCT03428646). Enrolled patients received their first dose of dupilumab at the baseline visit; there were no restrictions on post-baseline dupilumab dosing changes, or concomitant medication use; patients were encouraged to stay in the study if they discontinued dupilumab. Data presented are from an interim analysis (data cut taken as of November 2022); only ≥36 months of patient experience in PROSE at the time of interim analysis is reported. No formal hypothesis testing was performed; descriptive statistics are presented. Among 857 patients [mean (SD) age 40.1 (17.9) years and 42% male], mean (SD) duration of dupilumab treatment was 23.1 (13.7) months. At Month 36, 185 patients (21.6%) had discontinued from the study; the main reason was withdrawal of consent by the patient (76 patients, 8.9%). The proportion of patients with available observations reporting a Pruritus NRS score of 0/1 increased from baseline (2.7%) to Month 3 (28.1%) and continued to increase up to Month 36 (56.3%). Similarly, the proportion of patients with a clinician-reported ODS score of 0/1 also increased from baseline (2.2%) to Month 3 (39.8%) and up to Month 36 (65.1%). Safety was consistent with the known dupilumab safety profile. In this interim analysis of PROSE, a majority of patients reported a complete/near-complete pruritus response and overall disease severity response over a 36-month period.