P102 Raising the bar of efficacy in atopic dermatitis: lebrikizumab provides deep clinical and itch responses up to 16 weeks (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. We report the 16-week deep response of LEB combined with low-to-mid-potency TCS in patients with moderate-to-severe AD inadequately controlled or noneligible for CsA in the phase III ADvantage study. This study had a 16-week, randomized, double-blind, placebo (PBO)-controlled period plus a 36-week open-label period. Eligible patients were adults and adolescents (aged ≥ 12 to < 18 years) with Eczema Area and Severity Index (EASI) ≥ 16, Investigator’s Global Assessment (IGA) ≥ 3, and ≥ 10% body surface area affected, who were not adequately controlled with or not eligible for CsA. Patients were randomized 2 : 1 to LEB 250 mg every 2 weeks with a loading dose of LEB 500 mg at baseline and week 2, or PBO (every 2 weeks). Deep response was defined as having clear skin (IGA 0 and 100% improvement in EASI: EASI 100) or no or minimal itch [pruritus numerical rating scale (NRS) 0 or 1]. The percentage of patients achieving IGA 0, EASI 100 and pruritus NRS 0/1 at week 16 was reported. Missing data due to lack of efficacy or data after rescue medication usage (high-potency TCS or systemic treatment) were set to baseline and considered nonresponse. Other missing data were imputed using multiple imputation. In total, 331 patients were randomized (220 LEB+TCS and 111 PBO+TCS). Around 17% of patients had been previously exposed to dupilumab. At week 16, a higher proportion of patients receiving LEB+TCS vs. PBO+TCS achieved IGA 0 (16.0% vs. 5.0%, P < 0.01), EASI 100 (15.8% vs. 4.6%, P < 0.001) and pruritus NRS 0/1 (29.9% vs. 8.3%, P < 0.01). After 16 weeks of treatment, LEB led to deep skin response in > 15% of patients and deep itch response in close to 30% of patients. Deep response is therefore achievable with LEB in the short term, even in this difficult-to-treat population. Almirall, S.A. has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, 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.

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