Absolute EASI response achieved by lebrikizumab over 16 weeks in patients with moderate-to-severe atopic dermatitis

Document Type

Conference Proceeding

Publication Date

4-29-2025

Publication Title

J Dtsch Dermatol Ges

Abstract

Introduction: Efficacy of lebrikizumab (LEB) monotherapy for patients (pts) with moderate-to-severe atopic dermatitis (AD) as the percentage of improvement in the Eczema Area and Severity Index (EASI) has been established previously. Attainment of absolute EASI thresholds may provide additional clinically meaningful information. Objective: To assess the percentage of pts in ADvocate1 and ADvocate2 (ADv1&2) monotherapy trials achieving absolute EASI ≤ 7 (mild), EASI ≤ 1 (clear/almost clear) and 2 new cut-offs proposed as optimal targets: EASI ≤ 3 and EASI ≤ 5. Methods: Adults/adolescents were randomized 2:1 to receive LEB 250 mg every 2 weeks (Q2W) (n = 564) or placebo (PBO) (n = 287) for 16 weeks (W). Eligible pts had moderate-to-severe AD, with EASI ≥ 16 at baseline. Analyses were performed on the pooled modified intention to treat population. Proportion of pts achieving EASI ≤ 7, ≤ 5, ≤ 3 and ≤ 1 at W16 was assessed for the overall population and stratified by baseline EASI severity subgroups (BESS) (moderate: 16–21, severe: 21.1–50, and very severe: >50). Missing data and data after rescue were imputed using non-responder imputation. Results: A significantly greater proportion of pts treated with LEB vs PBO achieved EASI ≤ 7 at W16 (54% [n = 307/564] vs 18% [n = 52/287], p<0.001), and by BESS: moderate: 64% (n = 104/163) vs 38% (n = 27/71), p<0.001; severe: 52% (n = 185/359) vs 13% (n = 25/193), p<0.001; and very severe: 43% (n = 18/42) vs 0%, p<0.001. A significantly greater proportion of pts treated with LEB vs PBO achieved EASI ≤ 5 at W16 (48% [n = 272/564] vs 13% [n = 37/287], p<0.001), and by BESS: moderate: 58% (n = 94/163) vs 27% (n = 19/71), p<0.001; severe: 46% (n = 164/359) vs 9% (n = 18/193), p<0.001; very severe: 33% (n = 14/42) vs 0%, p<0.05. A significantly greater proportion of pts treated with LEB vs PBO achieved EASI ≤ 3 at W16 (36% [n = 203/564] vs 10% [n = 29/287], p<0.001), and by BESS: moderate: 41% (n = 66/163) vs 20% (n = 14/71), p<0.05; severe: 35% (n = 126/359) vs 8% (n = 15/193), p<0.001; very severe: 26% (n = 11/42) vs 0%, p<0.05. A significantly greater proportion of pts treated with LEB vs PBO achieved EASI ≤ 1 at W16 (20% [n = 113/564] vs 4% [n = 10/287], p<0.001), and by BESS: moderate: 20% (n = 33/163) vs 9% (n = 6/71), p<0.05; severe: 20% (n = 73/359) vs 2% (n = 4/193), p<0.001; very severe: 17% (n = 7/42) vs 0%, p<0.05. Conclusion: More than 50% of pts treated with LEB Q2W monotherapy for 16W achieved an EASI indicating mild AD; 48% and 36% of pts achieved optimal targets (EASI ≤ 5 and EASI ≤ 3), and approx. 20% of pts achieved more stringent endpoints indicating clear/almost clear skin.

Volume

23

First Page

1

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