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Secondary analysis of Phase 3 trials shows lebrikizumab improves absolute EASI response in moderate-to-severe atopic dermatitis

Secondary analysis of Phase 3 trials shows lebrikizumab improves absolute EASI response in…
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Key Takeaway
Note that lebrikizumab 250 mg Q2W significantly improved absolute EASI response versus placebo in moderate-to-severe atopic dermatitis.

This study is a secondary analysis of two Phase 3 trials involving adults and adolescents with moderate-to-severe atopic dermatitis. The sample size included 564 patients receiving lebrikizumab and 287 patients receiving placebo. The intervention was lebrikizumab 250 mg administered every 2 weeks, with placebo serving as the comparator. Follow-up assessments occurred at Week 16 and Week 52.

Significantly higher percentages of patients receiving lebrikizumab achieved each absolute EASI response (EASI≤7, ≤5, ≤3, and ≤1) compared to those receiving placebo. High rates of durable absolute EASI response were observed. Absolute EASI scores were generally low and stable among responders and reduced among non-responders.

Safety data, including adverse events, serious adverse events, discontinuations, and tolerability, were not reported. The study limitations include its nature as a post-hoc analysis. Funding or conflicts of interest were not reported. The percent EASI improvement is used in clinical trials to compare study arms and measure treatment effect size or impact, whereas absolute EASI scores are used in clinical practice.

Study Details

Study typeRct
Sample sizen = 564
EvidenceLevel 2
PublishedMay 2026
View Original Abstract ↓
The ADvocate trials (NCT04146363, NCT04178967) investigated adults/adolescents with moderate-to-severe atopic dermatitis (AD) receiving lebrikizumab (LEB) monotherapy, using percent improvement in the Eczema Area and Severity Index (EASI). In clinical trials, percent EASI improvement is used to compare study arms and measure treatment effect size/impact. In clinical practice, however, absolute EASI scores are used (especially in Europe), as they measure an individual's disease state regardless of baseline severity. This post-hoc analysis assessed absolute EASI response - EASI≤7, ≤5, ≤3, and ≤1 - from the ADvocate trials to understand LEB efficacy in adults/adolescents with moderate-to-severe AD. Week-16 data from patients receiving LEB 250 mg Q2W (n=564) were compared with placebo (n=287). Across baseline moderate/severe/very severe EASI and baseline Investigator's Global Assessment (IGA) 3/4, significantly higher percentages of patients receiving LEB than those receiving placebo achieved each absolute EASI response. Week--16 LEB EASI 75 responders (n=284) and per-protocol LEB non-responders (n=215) were assessed through week 52. Absolute EASI scores were generally low and stable among responders and reduced among non-responders. Overall, LEB was associated with high rates of durable absolute EASI response, even in cases of high baseline severity or suboptimal week-16 outcomes. Results reflect clinically meaningful improvements that could help guide clinical practice.
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