EVOLUTION OF EASI RESPONSE WITH LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS: POOLED RESULTS FROM TWO PHASE 3 TRIALS (ADVOCATE1 AND ADVOCATE2) AT WEEK 16

Document Type

Conference Proceeding

Publication Date

10-24-2023

Publication Title

Acta Derm Venereol

Abstract

Lebrikizumab ( LEB) i s a h igh-affinity m onoclonal a ntibody targeting interleukin-13 for the treatment of moderate-to-severe atopic dermatitis (AD). Phase III ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967) trials evaluated the efficacy and safety of LEB monotherapy in moderate-to-severe AD. To evaluate the evolution of Eczema Area and Severity Index (EASI) responses up to week 16 using pooled data from ADvocate1 and ADvocate2. Eligible moderate-to-severe AD patients (adults and adolescents [12-17 years, weighing ≥ 40 kg]) were randomized 2:1 to LEB 250 mg or placebo every 2 weeks for 16 weeks (induction period). EASI percentage improvement categories from baseline to week 16 are: EASI<50, EASI ≥50 to <75, EASI ≥75 to <90 and EASI ≥90. Analyses were performed in the modified Intention- To-Treat population (mITT). Patients who received rescue medication or discontinued treatment due to lack of efficacy were considered as non-responders. Missing data were handled through Markov chain Monte Carlo multiple imputation (MCMC-MI). Over 16 weeks (the induction phase), patients treated with LEB showed a positive EASI response evolution (29.2% EASI<50, 15.3% EASI ≥50 to <75, 20.9% EASI ≥75 to <90 and 34.5% EASI ≥90) compared to those in the PBO arm (67.0% EASI<50, 15.8% EASI ≥50 to <75, 8.0% EASI ≥75 to <90 and 9.2% EASI ≥90). Data from the pooled analysis of two Phase 3 trials showed that 70.7% of patients treated with LEB 250 mg every 2 weeks in monotherapy for the first 16 weeks achieved EASI≥50 and more than one third of patients achieved EASI≥90.

Volume

103

First Page

53

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