Silverberg JI, Thaci D, Seneschal J, Gold LS, Blauvelt A, Simpson E, Chu CY, Liu ZQT, Lima RG, Pillai S, and Guttman-Yassky E. Efficacy and safety of lebrikizumab in moderate-to-severe atopic dermatitis: results from two phase III, randomized, double-blinded, placebo-controlled trials. Br J Dermatol 2022; 187(3):E97-E98.
British Journal of Dermatology
Lebrikizumab, a high-affinity IgG-4 monoclonal antibody targeting interleukin (IL)-13, selectively prevents the formation of the IL-13Ra1/IL-4Ra heterodimer receptor signalling complex. Lebrikizumab demonstrated rapid, dose-dependent efficacy and an acceptable safety profile in patients with moderate-to-severe atopic dermatitis (AD) in a phase IIb trial (NCT03443024). Here, we report 16-week efficacy and safety outcomes of lebrikizumab monotherapy in patients with AD from two ongoing 52-week, randomized, double-blinded, placebo-controlled phase III trials – ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967). Eligible patients with moderate-to-severe AD [adults and adolescents (12–17 years of age, weighing ≥40 kg)] were randomized 2: 1 to subcutaneous lebrikizumab 250 mg or placebo every 2 weeks. Efficacy analyses included proportions of patients achieving Investigator’s Global Assessment (IGA) 0/1, Eczema Area and Severity Index (EASI)-75 and Pruritus Numerical Rating Scale (NRS) ≥ 4-point improvement from baseline (P ≥ 4) at week 16. Nonefficacy-related missing data were imputed by multiple imputation. In ADvocate1, proportions of patients treated with lebrikizumab 250 mg (n = 283) and placebo (n = 141) achieving IGA 0/1 at week 16 were 43.0% and 12.8% (P < 0.001); EASI-75 responses were 59.3% and 16.4% (P < 0.001); P ≥ 4 proportions were 46.3% and 12.7% (P < 0.001), respectively. In ADvocate2 (lebrikizumab, n = 281; placebo, n = 146), corresponding proportions for IGA 0/1 were 33.1% and 10.9% (P < 0.001); EASI-75 responses were 50.8% and 18.2% (P < 0.001); P ≥ 4 proportions were 38.3% and 11.3% (P < 0.001), respectively. The percentage of patients reporting ≥1 TEAE was comparable in ADvocate1 (lebrikizumab, 45.4%; placebo, 51.1%) and ADvocate2 (lebrikizumab 53.0%; placebo 66.2%). Data from two ongoing pivotal phase III trials suggest that lebrikizumab 250 mg Q2W provides an efficacious treatment option with an acceptable safety profile for patients with moderate-to-severe AD.