P104 Lebrikizumab improves quality of life in patients with moderate-to-severe atopic dermatitis inadequately controlled or ineligible for ciclosporin (ADvantage study)

Abstract Ciclosporin A (CsA) is indicated for the treatment of severe atopic dermatitis (AD), but its efficacy may not be optimal and its safety limits longer-term use. Lebrikizumab (LEB) is a high-affinity anti-interleukin-13 monoclonal antibody. In the ADvantage study (NCT05149313), LEB was dosed 250 mg every 2 weeks and administered with topical corticosteroids (TCS). At week 16 this regimen had significantly improved signs and symptoms of AD in adults and adolescents with moderate-to-severe AD inadequately controlled or ineligible for CsA, with an acceptable safety profile. The objective of this study was to assess the quality of life (QoL) at week 16 of patients with moderate-to-severe AD inadequately controlled with or ineligible for CsA. ADvantage is a 52-week study with a 16-week placebo (PBO)-controlled induction period plus a 36-week open-label maintenance period with LEB dosed every 2 weeks. Eligible patients were adults and adolescents (≥ 12 to < 18 years) with Eczema Area and Severity Index ≥ 16, Investigator’s Global Assessment ≥ 3, and ≥ 10% body surface area of AD involvement, not adequately controlled with or ineligible for CsA. Patients received concomitant low-to-mid-potency topical corticosteroids (TCS) through week 16. QoL was assessed by Dermatology Life Quality Index (DLQI). Here we report different endpoints: the percentage change from baseline (CFB), the percentage of patients achieving DLQI ≤ 5 and the percentage of patients achieving DLQI of 0 or 1 (0/1). Missing data due to lack of efficacy or data after rescue medication usage (high-potency TCS or systemic treatment) were imputed using nonresponder imputation. Other missing data were imputed using multiple imputation. Descriptive analyses of percentage CFB in DLQI were performed by mixed models for repeated measures. In total, 331 patients were randomized (220 LEB+TCS and 111 PBO+TCS) and 212 and 100, respectively, completed the 16-week period. The treatment groups had similar baseline characteristics. A greater percentage CFB in DLQI was obtained with LEB)TCS than PBO+TCS (−59.9% vs. −37.3%, P < 0.01) at week 16. Moreover, a higher percentage of patients on LEB+TCS achieved DLQI ≤ 5 (55.7% LEB+TCS vs. 34.7% PBO+TCS, P < 0.05) and DLQI 0/1 (30.6% LEB+TCS vs. 8.3% PBO+TCS, P < 0.001) at week 16, compared with PBO+TCS. LEB dosed every 2 weeks with TCS showed improvements in the QoL of adults and adolescents with moderate-to-severe AD inadequately controlled with or ineligible for CsA. A relevant number of patients reported no or minimal impact on their QoL after 16 weeks of treatment. Almirall, S.A. has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Lilly has exclusive rights for the development and commercialization of lebrikizumab in the USA and the rest of the world outside of Europe. Medical writing was funded by Almirall S.A.