Achieving Depth of Response in Skin Clearance and Itch Relief With Lebrikizumab is Associated With Minimal Impact of Atopic Dermatitis on Quality of Life

Abstract

In Phase 3, monotherapy trials, ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967), Week 16-responders treated with lebrikizumab (LEB) every 2 weeks (Q2W) and every 4 weeks (Q4W) demonstrated extended maintenance of deep response in skin clearance and itch improvement. In this post hoc analysis of ADvocate1/-2, among LEB responders (defined by achieving Investigator’s Global Assessment [IGA] 0 or 1 with ≥2-point improvement or ≥75% improvement in the Eczema Area and Severity Index [EASI75], and not receiving rescue medication, including topicals, at Week 16), we evaluated quality of life (QOL) improvements for patients who achieved a deep response to LEB at Week 52, defined as: IGA score 0 (clear skin); ≥90% or 100% reduction in EASI (EASI90; EASI100); or Pruritus Numeric Rating Scale (PNRS; 0-10, none to worst itch imaginable) scores 0 or 1 (PNRS01) at Week 52. QOL was assessed by the Dermatology Life Quality Index (DLQI), scored 0–30, with higher scores indicating a worse effect of AD on QOL (scores ≤5: no/minimal effect; scores ≥11: very large/extremely-large effect). Descriptive analyses using as-observed data were reported at baseline (Week 0) and Week 52 for deep responders regardless of treatment arm (pooled) and by treatment arms separately. For patients with IGA0 at Week 52, mean (SD) DLQI scores decreased from 14.0 (7.5) at baseline to 1.8 (2.7) at Week 52 in the pooled dataset (Nx=73) and from 12.6 (7.9) to 1.6 (2.8) for LEBQ4W (Nx=32). For patients with EASI90 at Week 52, the scores decreased from 14.6 (7.3) to 2.6 (3.3) in the pooled dataset (Nx=151) and from 14.4 (7.5) to 2.4 (3.3) for LEBQ4W (Nx=67). For patients with EASI100 at Week 52, the scores decreased from 13.9 (7.4) to 1.9 (2.8) in the pooled dataset (Nx=68) and from 12.8 (8.2) to 1.6 (2.9) with LEBQ4W (Nx=29). For PNRS01, the scores decreased from 14.1 (6.8) to 1.4 (1.9) in the pooled dataset (Nx=80) and from 14.1 (7.5) to 1.3 (2.3) with LEBQ4W (Nx=36). Deep response in skin clearance and itch relief was achievable with LEB and was associated with substantial improvement in QOL to levels indicating minimal-to-no impact of AD on QOL.