Lebrikizumab is associated with improvements in patient-reported symptoms and quality-of-life measures across Eczema Area and Severity Index response categories: pooled results from phase-3 randomized ADvocate1 and ADvocate2 studies in patients with moderate-to-severe atopic dermatitis

被引:0
作者
Blauvelt, Andrew [1 ]
Kircik, Leon [2 ,3 ]
Schlesinger, Todd [4 ,5 ]
Pierce, Evangeline [6 ]
Burge, Russel [6 ,7 ]
Behling, Michael [8 ]
Atwater, Amber Reck [6 ]
Elmaraghy, Hany [6 ]
Armstrong, April [9 ]
机构
[1] Blauvelt Consulting LLC, Annapolis, MD USA
[2] Icahn Sch Med Mt Sinai, New York, NY USA
[3] Indiana Univ Sch Med, Indianapolis, IN USA
[4] Clin Res Ctr Carolinas, Charleston, SC USA
[5] George Washington Univ, Sch Med & Hlth Sci, Washington, DC USA
[6] Eli Lilly & Co, 893 S Delaware St, Indianapolis, IN 46285 USA
[7] Univ Cincinnati, Cincinnati, OH USA
[8] Syneos Hlth, Morrisville, NC USA
[9] Univ Calif Los Angeles, Keck Sch Med, Los Angeles, CA USA
关键词
Atopic dermatitis; lebrikizumab; Eczema Area and Severity Index; quality of life; HARMONIZING OUTCOME MEASURES; SLEEP DISTURBANCE; BURDEN; STATEMENT; TRIALS; ADULTS;
D O I
10.1080/09546634.2024.2442720
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
BackgroundLebrikizumab monotherapy significantly improved signs and symptoms in patients with moderate-to-severe atopic dermatitis (AD) in phase 3 Advocate1 and ADvocate2 studies. ObjectiveTo 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). MethodsIn 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. ResultsAt 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 (p < 0.001). Anxiety and depression scores improved for most EASI response categories (p < 0.01). ConclusionLebrikizumab-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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