Background: Lebrikizumab monotherapy significantly improved signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) in phase 3 Advocate1 and ADvocate2 studies.
Objective: To evaluate improvements in patient-reported symptoms and quality-of-life (QoL) measures by Eczema Area and Severity Index (EASI) response categories using pooled Advocate1 and ADvocate2 data (post hoc analysis).
Methods: In the 52-week (W) (16-W induction + 36-W maintenance) double-blind, placebo-controlled ADvocate1 and ADvocate2 studies, patients were randomized (2:1) to receive subcutaneous lebrikizumab 250 mg or placebo every 2 weeks. Investigator Global Assessment (IGA) 0/1 and improvements in QoL outcomes were assessed at W16 among lebrikizumab-treated patients.
Results: At W16, 564 patients were categorized by EASI response (EASI <50: 32.8%; EASI ≥50-<75: 13.8%; EASI ≥75-<90: 20.2%; EASI ≥90: 33.2%). Patients with higher EASI responses showed higher IGA 0/1 response rates (EASI ≥75-<90: 37.7% and EASI ≥90: 86.1%). Pruritus NRS (least squares mean range: -1.5 to -4.4), sleep-loss score (-0.6 to -1.6), and Dermatology Life Quality Index (-3.3 to -10.6) improved across EASI response categories ( < 0.001). Anxiety and depression scores improved for most EASI response categories ( < 0.01).
Conclusion: Lebrikizumab-treated patients with moderate-to-severe AD showed improved symptoms and QoL across EASI response categories at W16, with greater improvements observed in patients with higher EASI responses.
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http://dx.doi.org/10.1080/09546634.2024.2442720 | DOI Listing |
J Dermatolog Treat
December 2025
Keck School of Medicine at University of California Los Angeles, Los Angeles, CA, USA.
Background: Lebrikizumab monotherapy significantly improved signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) in phase 3 Advocate1 and ADvocate2 studies.
Objective: To evaluate improvements in patient-reported symptoms and quality-of-life (QoL) measures by Eczema Area and Severity Index (EASI) response categories using pooled Advocate1 and ADvocate2 data (post hoc analysis).
Methods: In the 52-week (W) (16-W induction + 36-W maintenance) double-blind, placebo-controlled ADvocate1 and ADvocate2 studies, patients were randomized (2:1) to receive subcutaneous lebrikizumab 250 mg or placebo every 2 weeks.
Background: Lebrikizumab demonstrated statistically significant improvements in patients with moderate-to-severe atopic dermatitis at week 16 with a durable response up to week 52.
Objective: To investigate the efficacy of lebrikizumab-treated patients at 52 weeks who did not achieve the ADvocate1 and ADvocate2 protocol-defined response criteria (≥75% improvement in the Eczema Area and Severity Index [EASI 75] or Investigator Global Assessment [IGA] 0/1 with ≥2-point improvement without rescue medication) after 16 weeks.
Methods: This analysis includes observed data for patients who received lebrikizumab every 2 weeks during the induction period, did not achieve the protocol-defined response, and subsequently received open-label lebrikizumab treatment.
Clin Exp Dermatol
December 2024
Department of Dermatology, Emory University, Atlanta, USA.
Pruritus is a hallmark symptom of atopic dermatitis (AD) and is known to worsen patients' health-related quality of life. Lebrikizumab is a high-affinity monoclonal antibody which binds IL-13, a dominant cytokine implicated in AD. This study includes data from two Phase 3 randomized controlled trials assessing the efficacy and safety of lebrikizumab in patients with moderate-to-severe AD, ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967).
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