Baseline Demographics and Severity and Burden of Atopic Dermatitis in Adult Patients Initiating Dupilumab Treatment in a Real-World Registry (PROSE)

Abstract

Introduction: Dupilumab was initially approved in 2017 as the first biologic therapy for atopic dermatitis (AD). We characterized adults with AD initiating dupilumab in a real-world setting in the USA/Canada.

Methods: PROSE is an ongoing, longitudinal, prospective, observational, multicenter registry of patients with AD initiating dupilumab per country-specific prescribing information. We report baseline data (day of first dupilumab injection) for patients enrolled from April 2018 through July 2019.

Results: Among 315 patients (mean age 42.5 years, 55.2% female), the median AD duration was 17.0 years; 65.4% reported a history of type 2 inflammatory comorbidities (e.g., allergic rhinitis, asthma), and 93.3% reported treatment(s) for AD in the previous year, including topical corticosteroids (90.8%), systemic corticosteroids (36.2%), and nonsteroidal systemic therapies (14.0%). In total, 89.2% had an Overall Disease Severity score of 3 (moderate) or 4 (severe). Other mean disease severity scores included the following: Eczema Area and Severity Index 16.9 (range 0-72), body surface area affected 26.8%, Patient-Oriented Eczema Measure 18.5 (range 0-28), Dermatology Life Quality Index 12.7 (range 0-30), and pruritus Numerical Rating Scale score 6.9 (range 0-10).

Conclusion: Patients initiating dupilumab have longstanding moderate-to-severe AD with significant disease burden and frequent type 2 comorbidities.

Gov identifier: NCT03428646.

Keywords: Atopic dermatitis; Baseline; Dupilumab; Eczema; Registry.

Fig. 1

Disease characteristics (EASI, POEM, DLQI) by ODS. ^aEASI scale 0–72, with 0–1 indicating clear/almost clear; 1.1–7, mild; 7.1–21, moderate; 21.1–50, severe; and 50.1–72, very severe [24]. ^bPOEM scale 0–28, with 0–2 indicating clear/almost clear mild; 0–7 or 3–7, mild; 8–16 or 8–19, moderate; 17–24, 17–28, or 20–28, severe; 25–28, very severe [–27]. ^cDLQI scale 0–30, with 0–5 indicating mild; 6–10, moderate; 11–30, severe [26, 27]. DLQI Dermatology Life Quality Index, EASI Eczema Area and Severity Index, NA not available, ODS Overall Disease Severity, POEM Patient-Oriented Eczema Measure, PRO patient-reported outcome, SD standard deviation