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
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
