Patients maintain stable response with no or minimal fluctuations during 3 years of continuous treatment with lebrikizumab during long-term extension trial

Document Type

Conference Proceeding

Publication Date

2-26-2026

Publication Title

J Dtsch Dermatol Ges

Keywords

Dermatology

Abstract

Background: Lebrikizumab (LEB), a high-affinity IL-13 inhibitor, demonstrated stability of response up to 2 years as monotherapy treatment in adults&adolescents (≥ 40 kg) with moderate-to-severe atopic dermatitis (AD) from the pivotal phase 3 trials (ADvocate1, NCT04146363; ADvocate2, NCT04178967; ADjoin, NCT04392154). Methods: Here, we assessed the stability of response up to 3 years of LEB treatment in responder patients at Week (W) 16 after the induction with LEB Q2W, who were re-randomized to LEB Q2W or Q4W for 36W maintenance period in ADvocate1 and 2, and continued the same treatment (LEB Q2W, n = 82; LEB Q4W, n = 99) in ADjoin, the LEB long-term extension study up to 3 years. Response at W16 was defined as IGA 0/1 or EASI 75 without rescue medication in ADvocate1 and 2. Topical rescue medications were permitted during the analysis period (in W16-152). This analysis reported the proportion of LEB-treated patients who maintained EASI 75 (in W16 EASI 75 responders) and absolute EASI ≤ 7 response (in W16 EASI ≤ 7 responders), at individual level, in ≥ 80% of attended visits from W16-152. Pruritus Numeric Rating Scale (PNRS) was collected up to W104. Proportion of LEB-treated patients who achieved PNRS ≥ 3-point improvement among W16 EASI 75 responders, and maintained the PNRS response in ≥ 80% of attended visits from W16-104 was reported. Observed data was analyzed regardless of rescue medication use or discontinuation from treatment. Results: A stable EASI 75 response from W16-152 was reported in 92.9% of patients receiving LEB Q4W and 92.7% for LEB Q2W. A stable EASI ≤ 7 response from W16-152 was achieved for 96.8%, receiving LEB Q4W and 97.3% for LEB Q2W. In patients with baseline PNRS ≥ 3, achieving EASI 75 and PNRS ≥ 3-point improvement at W16, a stable PNRS ≥ 3-point improvement from W16-104 was achieved by 93.8% (N = 65) of patients receiving LEB Q4W and 88.7% (N = 62) for LEB Q2W. During ADjoin (W52-152) the use of low-moderate and high potency topical corticosteroids (TCS) was 9.1% (n = 9) in both TCS potency categories for LEB Q4W, whereas for LEB Q2W was 4.9% (n = 4) and 6.1% (n = 5), respectively. Conclusions: LEB provides long-term stability in skin response and itch relief with no or minimal fluctuations measured by EASI 75, EASI <7 and PNRS.

Volume

24

First Page

17

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