Absolute Eczema Area and Severity Index Responses with Lebrikizumab in Patients with Moderate-to-severe Atopic Dermatitis: A Secondary Analysis of Two Phase 3 Trials

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.