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INTRODUCTION

Atopic dermatitis (AD) affects multiple areas of the body, some of which may be more refractory to treatment. We evaluated improvements in the Eczema Area and Severity Index (EASI) by body region and clinical signs for each body region in lebrikizumab-treated patients with moderate-to-severe AD.

METHODS

ADvocate 1 and ADvocate 2 compared lebrikizumab 250 mg as monotherapy every 2 weeks versus placebo for 16 weeks. Efficacy measures included EASI, which rates the extent and severity of four clinical signs (erythema, edema/papulation, excoriation, lichenification) in four body regions (head/neck, upper extremities, trunk, lower extremities). Analyses are post hoc.

RESULTS

Mean baseline EASI, body region EASI subscores, and the severity of clinical signs were consistent across both studies (EASI ranging from 16.0 to 72.0). At week 16 in both studies, patients treated with lebrikizumab showed significantly greater percent improvement in EASI across all body regions versus placebo (p ≤ 0.001), with improvements as early as week 2. In ADvocate 1, all clinical signs significantly improved across all body regions at week 16 with lebrikizumab (51.4-71.6% improvement) versus placebo (23.1-43.5%, p ≤ 0.001), with significant improvements as early as week 2 for all signs. Significant improvements for all clinical signs at week 16 were also seen in ADvocate 2 for lebrikizumab (53.5-75.6%) versus placebo (28.5-41.2%, p ≤ 0.001) and as early as week 2 for all body regions and signs except head/neck erythema and lower extremity erythema, edema/papulation, and lichenification, which showed significant improvement by week 4.

CONCLUSIONS

Lebrikizumab as monotherapy consistently and rapidly reduced the extent of involvement and severity of AD in all EASI clinical signs and body regions, including the head and neck region and clinical sign of lichenification, compared with placebo.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967).

引言

特应性皮炎（AD）会影响身体多个部位，其中一些部位可能对治疗更具难治性。我们评估了接受lebrikizumab治疗的中度至重度AD患者按身体部位划分的湿疹面积和严重程度指数（EASI）的改善情况以及每个身体部位的临床体征。

方法

ADvocate 1和ADvocate 2试验比较了每2周一次250mg的lebrikizumab单药治疗与安慰剂治疗16周的效果。疗效指标包括EASI，该指标对四个身体部位（头颈部、上肢、躯干、下肢）的四种临床体征（红斑、水肿/丘疹、抓痕、苔藓化）的范围和严重程度进行评分。分析为事后分析。

结果

两项研究的平均基线EASI、身体部位EASI子评分和临床体征严重程度一致（EASI范围为16.0至72.0）。在两项研究的第16周，接受lebrikizumab治疗的患者在所有身体部位的EASI改善百分比均显著高于安慰剂组（p≤0.001），早在第2周就出现了改善。在ADvocate 1中，与安慰剂组（改善23.1 - 43.5%，p≤0.001）相比，在第16周时，接受lebrikizumab治疗的患者在所有身体部位的所有临床体征均有显著改善（改善51.4 - 71.6%），所有体征早在第2周就有显著改善。在ADvocate 2中，与安慰剂组（改善28.5 - 41.2%，p≤0.001）相比，在第16周时，接受lebrikizumab治疗的患者在所有临床体征方面也有显著改善（改善53.5 - 75.6%），除头颈部红斑以及下肢红斑、水肿/丘疹和苔藓化外，所有身体部位和体征早在第2周就有改善，这些在第4周时出现显著改善。