Baseline Characteristics in Patients with Atopic Dermatitis from the North American Prospective Observational Study of Lebrikizumab (ADjoy)

Abstract

Introduction: Lebrikizumab demonstrated long-term efficacy and safety in Phase 3 clinical trials in adolescent and adult patients with moderate-to-severe AD. Preliminary baseline demographics and patient characteristics from the real-world study ADjoy are reported herein.

Methods: ADjoy, a 104-week, prospective, Phase 4, multicentre, single-arm observational study, reflects real-world lebrikizumab treatment in participants with moderate-to-severe AD within clinical practice settings. This analysis reports data from the first 134 participants enrolled in US and Canada. All data are reported as observed; no imputations were conducted. The proportion of missing data are presented.

Results: At baseline, median (IQR) age was 39.6 (27.3, 53.2) years, weight was 81.7 (68.1, 100.6) kg, and 53.7% of participants were female. Median (IQR) age at AD onset was 25.2 (5.7, 44.8) and duration of AD was 8.5 (2.6, 22.2) years. Participants were White (69.4%), Black or African American (12.7%), Asian (10.4%), and Hispanic or Latino (10.4%). Participants had Fitzpatrick Skin Phototypes of I-III (71.0%) and IV-VI (29.0%). AD-associated comorbidities were present in 107 participants (79.9%), including seasonal allergy (43.5%) and asthma (33.3%) as the most common; medical history of conjunctivitis was 13.1%. At baseline, commonly affected areas included arms (67.2%), legs (60.2%), face (53.1%), back (52.3%), anterior trunk (52.3%), hands (42.2%), and anterior neck (37.5%). Participants had moderate (66.4%) to severe (15.7%) disease activity based on the Investigator’s Global Assessment scores, with a median (IQR) Eczema Area Severity Index score of 9.2 (3.6, 16.8), Pruritus Numeric Rating Scale was 7.0 (5.0, 8.0), and Atopic Dermatitis Control Tool was 13.0 (9.0, 17.0), indicating uncontrolled atopic dermatitis. Dermatology Life Quality Index was 11.0 (6.0, 16.0). Participants had Patient Global Impression of Severity-AD scores of 1 (4.1%), 2 (9.0%), 3 (22.1%), 4 (39.3%), and 5 (25.4%). Of note, 47.0% were biologic naïve.

Conclusion: This is the first disclosure of real-life patients with AD initiating lebrikizumab in the US and Canada. This interim analysis shows a heterogeneous, poorly controlled AD population initiating lebrikizumab, highlighting still an unmet need in patient’s prior treatments to control disease activity.