Efficacy and Safety of Lebrikizumab in Adult and Adolescent Patients With Skin of Color and Moderate-to-Severe Atopic Dermatitis: An Interim Analysis of the Open-Label Phase 3b Trial, ADmirable

Document Type

Conference Proceeding

Publication Date

10-2024

Publication Title

Current Medical Research and Opinion

Abstract

Background: We present interim results of an open-label Phase 3btrial, the first designed to evaluate lebrikizumab for moderate-to-severe AD in patients with skin of color (SOC) (ADmirable; NCT05372419).Objectives: To present interim, 16-week results from ADmirable (NCT05372419), a phase 3b, open-label, 24-week study, the first to evaluate the safety and efficacy of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis. To describe innovative objective measures of pigment, erythema, and post-inflammatory hyper- and hypo-pig-mentation in a clinical trial dedicated to patients with skin of color and atopic dermatitis. Methods: Patients were aged ≥12 years (≥40 kg for adolescents)with Fitzpatrick Phototype IV–VI and self-reported race other than White. Lebrikizumab 500-mg loading dose was administered at base-line and Week-2 followed by 250-mg every 2 weeks to Week-16.Results: This analysis includes 50 enrolled patients. Baseline mean(SD) age was 42.2 (19.7) years; AD disease duration was 19.3 (15.8)years; 23 (46%) were female; 40 (80%), 7 (14%), and 3 (6%) were Black/African-American, Asian, American Indian/Alaska Native race, respectively; 11 (22%) were Hispanic/Latino and 39 (78%) were non-Hispanic/Latino. Proportions of patients with Fitzpatrick Phototypes IV, V, VI were 42, 22, 36%, respectively. The observed proportion of patients achieving ≥75% reduction in Eczema Area and Severity Index (EASI 75) at Week-16 was 68.3%; Investigator’s Global Assessment of 0 or 1 with ≥2-point improvement was 39.0%. Mean change and percentage change, respectively, were −22.2 and −79.1% EASI and −4.0 and −53.9% Pruritus Numeric Rating Scale. PDCA-DermTM, a new scale describing post-inflammatory lesions com-pared to adjacent unaffected skin, identified improvement in mean% change from baseline for hypo- and hyper-pigmented lesions. Additional innovative objective measures of pigment and erythema were utilized in this trial. There were no serious adverse events. Conclusion: These data support enduring efficacy and safety of lebrikizumab in patients with AD and SOC.

Volume

40

Issue

Suppl 3

First Page

S33

Last Page

S34

Comments

National Association of Specialty Pharmacy (NASP) Annual Meeting & Expo, October 6-9, 2024, Nashville, TN

DOI

10.1080/03007995.2024.2390294

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