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
Recommended Citation
Wollenberg A, Warren RB, Silverberg JI, Guttman-Yassky E, Thaçi D, Irvine AD, Stein Gold LF, Blauvelt A. 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. Acta Derm Venereol 2023; 103:53.
Document Type
Conference Proceeding
Publication Date
10-24-2023
Publication Title
Acta Derm Venereol
Keywords
lebrikizumab, placebo, adolescent, adult, atopic dermatitis, child, clinical trial, comparative effectiveness, conference abstract, controlled study, drug efficacy, drug safety, drug therapy, eczema, Eczema Area and Severity Index, female, human, male, Markov chain Monte Carlo method, meta analysis, monotherapy, phase 3 clinical trial (topic), randomized controlled trial (topic)
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
