P105 Lebrikizumab improves quality of life and wellbeing of patients with moderate-to-severe atopic dermatitis inadequately controlled with or ineligible for ciclosporin: German extension results (week 76) of the ADvantage study

Abstract Lebrikizumab (LEB), a high-affinity anti-interleukin-13 monoclonal antibody, showed efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD). Ciclosporin A (CsA) is indicated for severe AD, but its efficacy may not be optimal and its safety limits longer-term use. The objective of this study was to assess the quality of life (QoL) and wellbeing of patients with moderate-to-severe AD receiving LEB. Eligible patients were inadequately controlled with or ineligible for CsA and were followed up to week 76 (German extension of the ADvantage study, NCT05149313). 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, and not adequately controlled with or not eligible for CsA. Patients received concomitant low-to-mid-potency topical corticosteroids (TCS) through week 16; from W16 onwards TCS use was at investigator discretion. Patients who completed the 52-week maintenance period were eligible to join the extension-period, to continue LEB every 4 weeks for a minimum of 24 additional weeks (German extension). QoL was assessed as the percentage of change from baseline in the Dermatology Life Quality Index (DLQI) score. From week 0 to week 16, Ancova models were applied, and from week 16 to week 76, analyses were performed as observed. Wellbeing was assessed through the five-item WHO Well-being Index (WHO-5). WHO-5 has a range of 0–100, with 100 representing maximal wellbeing. The mean WHO-5 score in the German general population was 64.7, with a score of 52.2 in women with breast cancer and 51.4 in patients with diabetes with distress. Analyses were performed as observed. In total, 43 patients were included. At week 16 the change in DLQI from baseline was −78.0% (n = 31) for LEB every 2 weeks + TCS, and −59.2% (n = 12) for PBO every 2 weeks + TCS. At week 52 (LEB every 2 weeks ± TCS) the change in DLQI from baseline was −77.1% (n = 38), and at week 76 (LEB every 4 weeks ± TCS) it was −78.9% (n = 29). At baseline, the mean WHO-5 score was 40.1 (n = 28) in patients in the LEB arm and 35 (n = 12) in patients on PBO. At week 16 these scores had increased to 61.7 (n = 28) in patients treated with LEB every 2 weeks + TCS and 51.7 (n = 12) in those treated with PBO every 2 weeks + TCS. From week 16, the WHO-5 scores remained stable: at week 52 it was 60.9 (n = 28) in patients with LEB every 2 weeks ± TCS, and at week 76 it was 61.7 (n = 30) in patients treated with LEB every 4 weeks ± TCS. In the German extension population with moderate-to-severe AD inadequately controlled with or ineligible for CsA, LEB showed improvements in QoL and wellbeing up to week 76. 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.