Lebrikizumab in combination with topical corticosteroids provides significant improvement in quality of life in patients with moderate-to-severe atopic dermatitis not adequately controlled or non-eligible for cyclosporine: a placebo-controlled, randomized phase 3 clinical study (ADvantage)
Tommaso LUPIERI 1; Richard B. WARREN 2, José Manuel CARRASCOSA 3, Ziad REGUIAI 4, Franz J. LEGAT 5, Barbara REWERSKA 6, H. Chih-ho HONG 7, Clara ARMENGOL 8, Meritxell FALQUÉS 8, Helena AGELL 8, Eric MASSANA 8, Esther GARCIA GIL 8, Andreas WOLLENBERG 9
Lebrikizumab (LEB) has demonstrated efficacy and safety in adults/adolescents with moderate-to-severe atopic dermatitis (AD) in phase 3 trials.
Cyclosporine A (CsA) is approved for treatment of severe AD, but its efficacy and safety may not be optimal. We report 16-Week (W) efficacy and quality of life (QoL) in patients with moderate-to-severe AD not adequately controlled/non-eligible for CsA who are treated with LEB plus low- or mid-potency topical corticosteroids (TCS) in the phase 3 ADvantage study (NCT05149313).
It is a 52-W study with a 16-W, randomized, double-blind, PBO-controlled, parallel-group period plus 36-W open-label maintenance period. Eligible patients were adults/adolescents (≥12-<18 years) with an Eczema Area and Severity Index (EASI)≥16, Investigator’s Global Assessment (IGA)≥3, and ≥10% body surface area of AD involvement who were not adequately controlled/non-eligible for CsA.
Patients were randomized 2:1 to LEB 250mg every 2-W (Q2W) with a loading dose of LEB 500mg at baseline and W2, or PBO (Q2W).
Efficacy endpoints: SCORing Atopic Dermatitis (SCORAD) change from baseline (CFB) at W16. QoL endpoints: percentage of patients achieving Dermatology Life Quality Index (DLQI)≤5 and percentage of patients achieving DLQI 0/1 at W16. Missing data due to lack of efficacy or data after rescue medication usage were imputed using non-responder imputation. Other missing data were imputed using multiple imputation.
331 patients were randomized (220 LEB+TCS: 111 PBO+TCS). A greater SCORAD percent CFB was obtained with LEB+TCS vs PBO+TCS (-56.6% vs -36.3%, nominal p<0.01) at W16. Moreover, a higher percentage of patients on LEB+TCS achieved DLQI≤5 (55.7% LEB+TCS vs 34.7% PBO+TCS, nominal p<0.05) and DLQI 0/1 (30.6% LEB+TCS vs 8.3% PBO+TCS, nominal p<0.001) responses at W16 vs PBO+TCS.
In patients who have failed to CsA or for whom CsA is not medically advisable, LEB 250mg Q2W plus TCS significantly improved SCORAD and QoL at W16 in adults/adolescents with moderate-to-severe AD.
Tommaso Lupieri Sinibaldi