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在湿疹面积及严重程度指数(EASI)各反应类别中,乐必妥单抗与患者报告的症状改善及生活质量指标改善相关:中度至重度特应性皮炎患者3期随机ADvocate1和ADvocate2研究的汇总结果。

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.

作者信息

Blauvelt Andrew, Kircik Leon, Schlesinger Todd, Pierce Evangeline, Burge Russel, Behling Michael, Atwater Amber Reck, ElMaraghy Hany, Armstrong April

机构信息

Blauvelt Consulting, LLC, Annapolis, MD, USA.

Icahn School of Medicine at Mount Sinai, New York, NY, USA.

出版信息

J Dermatolog Treat. 2025 Dec;36(1):2442720. doi: 10.1080/09546634.2024.2442720. Epub 2025 Jan 6.

Abstract

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.

摘要

背景

在3期Advocate1和ADvocate2研究中,lebrikizumab单药疗法显著改善了中度至重度特应性皮炎(AD)患者的体征和症状。

目的

使用汇总的Advocate1和ADvocate2数据(事后分析),按湿疹面积和严重程度指数(EASI)反应类别评估患者报告的症状和生活质量(QoL)指标的改善情况。

方法

在为期52周(16周诱导期+36周维持期)的双盲、安慰剂对照的ADvocate1和ADvocate2研究中,患者按2:1随机分组,每2周接受一次皮下注射250mg的lebrikizumab或安慰剂。在第16周时,对接受lebrikizumab治疗的患者评估研究者整体评估(IGA)0/1以及QoL结局的改善情况。

结果

在第16周时,564名患者按EASI反应进行分类(EASI<50:32.8%;EASI≥50-<75:13.8%;EASI≥75-<90:20.2%;EASI≥90:33.2%)。EASI反应较高的患者显示出较高的IGA 0/1反应率(EASI≥75-<90:37.7%,EASI≥90:86.1%)。瘙痒数字评定量表(最小二乘均值范围:-1.5至-4.4)、睡眠障碍评分(-0.6至-1.6)和皮肤病生活质量指数(-3.3至-10.6)在各EASI反应类别中均有改善(P<0.001)。大多数EASI反应类别中的焦虑和抑郁评分有所改善(P<0.01)。

结论

接受lebrikizumab治疗的中度至重度AD患者在第16周时,各EASI反应类别中的症状和QoL均有改善,EASI反应较高的患者改善更为明显。

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