Efficacy and safety of lebrikizumab at 16 weeks: Pooled analyses from ADvocate1 and ADvocate2 phase III trials in patients with moderate-to-severe atopic dermatitis
Recommended Citation
Warren RB, Silverberg JI, Guttman-Yassky E, Thaçi D, Irvine AD, Stein Gold LF, Blauvelt A, Simpson EL. Efficacy and safety of lebrikizumab at 16 weeks: Pooled analyses from ADvocate1 and ADvocate2 phase III trials in patients with moderate-to-severe atopic dermatitis. Br J Dermatol 2023; 188:iv54.
Document Type
Conference Proceeding
Publication Date
8-8-2023
Publication Title
Br J Dermatol
Keywords
lebrikizumab, placebo, adolescent, adult, adverse drug reaction, atopic dermatitis, child, clinical trial, conference abstract, controlled study, double blind procedure, drug efficacy, drug safety, drug therapy, eczema, Eczema Area and Severity Index, female, human, male, Markov chain Monte Carlo method, meta analysis, monotherapy, numeric rating scale, outcome assessment, phase 3 clinical trial (topic), pruritus, randomized controlled trial (topic), school child, side effect
Abstract
Lebrikizumab (LEB) is a high-affinity monoclonal antibody targeting interleukin (IL)-13, preventing IL-13 signalling via the IL-4Rα/IL-13Rα1 receptor complex. Here, we report 16-week efficacy and safety outcomes of LEB monotherapy in patients with moderate-to-severe atopic dermatitis from two 52-week, randomized, double-blinded, placebo-controlled phase III trials, ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967). Eligible adults and adolescents (aged 12-17 years, weighing≥40 kg) from ADvocate1 and ADvocate2 were randomized (2 : 1) to subcutaneous LEB 250 mg (500 mg loading dose at baseline and week 2) or placebo every 2 weeks (Q2W). Efficacy analyses included proportions of patients achieving Investigator's Global Assessment (IGA) 0/1 and Eczema Area and Severity Index (EASI)-75 (coprimary endpoints), EASI-90, and pruritus numeric rating scale (NRS) ≥ 4-point improvement from baseline to week 16. This was a pooled analysis of ADvocate1 and ADvocate2, where IGA 0/1 and EASI-75 and EASI-90 were analysed in 564 and 287 patients (LEB 250 mg and placebo), respectively, and pruritus NRS in 516 and 264 patients, respectively. Cochran-Mantel-Haenszel with Markov chain Monte Carlo multiple imputation was performed. Patients treated with LEB 250 mg and placebo for 16 weeks achieved, respectively, IGA 0/1 response rates of 38.1% (n=215) and 11.7% (n=34; P<0.001) EASI-75 responses of 55.4% (n=313) and 17.2% (n=49 P<0.001); EASI-90 responses of 34.5% (n=195) and 9.2% (n=26) (P<0.001); and pruritus NRS≥4-point improvement responses of 42.9% (n=221) and 12.2% (n=32; P<0.001) The percentage of patients reporting one or more treatment emergent adverse event(s) was lower in the LEB group (49.6%) than in the placebo group (59.0%; P=0.009). These data suggest that LEB 250 mg Q2W for 16 weeks is an efficacious and safe treatment option for adult and adolescent patients with moderate-to-severe atopic dermatitis.
Volume
188
First Page
iv54
