Baseline Characteristics and Treatment Patterns of Patients with Atopic Dermatitis Treated with Oral Systemic Therapies: An Interim Analysis of the AD-REAL Study.

Abstract

Introduction: AD-REAL is an ongoing 1-year multinational observational cohort study evaluating oral systemic therapies in the management of adults with atopic dermatitis (AD) in a real-world practice across four European countries. Herein, we provide insights on baseline disease characteristics and treatment patterns of patients treated with oral systemic therapies, including baricitinib.

Methods: AD-REAL included adults with moderate-to-severe AD for ≥ 6 months, who were initiated on an oral systemic treatment in clinical practice and enrolled either in the baricitinib or the other oral systemic (OOS) cohort. Here, we report baseline characteristics, including clinician-assessed outcomes (Eczema Area and Severity Index [EASI]) and patient-reported outcomes (PROs), and explore AD subgroups based on body surface area (BSA) ≤ 40% and Itch numerical rating scale (NRS) ≥ 7. Continuous outcomes were reported using mean and standard deviation (SD) and categorical variables using frequencies. Baseline continuous variables with missing data were imputed using the multiple imputation method.

Results: Baseline demographics were consistent across both baricitinib and OOS cohorts. Patients showed long disease duration (26.2 years), refractory to several systemic options, and a moderate EASI mean (SD) score of 17.5 (10.7). The majority (53.7%) presented with severe Validated Investigator Global Assessment (vIGA) and highly impacted Dermatology Life Quality Index (DLQI) score (14.0 [7.1]). At baseline, patients were predominantly female, with AD mainly affecting face/neck (89.4%) and upper extremities (90.3%). About 68.4% presented with BSA ≤ 40 and 33.8% with BSA ≤ 40 and Itch NRS ≥ 7. From those with BSA ≤ 40% and Itch NRS ≥ 7, 63.9% were treated with Janus kinase inhibitors (JAKi).

Conclusion: This analysis provides key information on baseline disease characteristics of patients treated with oral systemics, including baricitinib. Most patients treated with oral systemics in AD-REAL had long-lasting disease, refractory to systemic therapies, with moderate skin affectation but severe itch and impact on quality of life. AD-REAL is the first study to show many patients in real-world practice who are treated with oral systemics present with BSA ≤ 40 and Itch NRS ≥ 7, and most of these patients were treated with JAKi.