P145 Lebrikizumab demonstrates significant efficacy and stable long-lasting response in patients with atopic dermatitis with skin of colour

Abstract

Lebrikizumab demonstrated efficacy and stability of response in the ADvocate1/2 phase III studies (NCT04146363 and NCT04178967) and ADjoin long-term extension (NCT04392154) in patients with moderate-to-severe atopic dermatitis (AD). We examine the stability of efficacy in individuals with self-reported Black, Asian, American Indian/Alaskan Native, or Native Hawaiian/Pacific Islander race – referred to here as skin of colour. We report the week 16 efficacy of lebrikizumab by racial subgroups (ADvocate1/2) and stability of response up to 3 years in patients with skin of colour who achieved clinical response with lebrikizumab at week 16 (ADjoin). Eligible patients were randomized 2 : 1 to lebrikizumab or placebo every 2 weeks (q2w) in ADvocate1/2. Efficacy endpoints measured from baseline were Investigator’s Global Assessment (IGA) score of 0 or 1 with ≥ 2-point improvement, ≥ 75% and ≥ 90% improvement in Eczema Area and Severity Index (EASI 75 and EASI 90) and ≥ 4-point improvement in Pruritus Numerical Rating Scale (P-NRS). Subsequent data from patients who received rescue medication or discontinued treatment due to lack of efficacy were imputed as nonresponse, and missing data were handled via multiple imputation. Week 16 responders (EASI 75 or IGA 0/1 without rescue medication) were included in the long-term stability analysis (ADjoin), with observed data used regardless of rescue medication or discontinuation. Stability was defined as maintaining response during ≥ 80% of attended visits. Most patients in ADvocate1/2 (818 of 851, 96.1%) were Asian (22.6%), Black/African American (9.9%) or White (63.7%). At week 16, no significant treatment-by-race interactions were observed for patients achieving EASI 75, EASI 90, IGA 0/1 or ≥ 4-point P-NRS improvement; efficacy data are to be presented. In ADjoin, patients receiving lebrikizumab every 4 weeks (q4w) had a mean (SD) baseline EASI score of 28.9 (12.2) and P-NRS of 6.8 (2.1). Those with dosing q2w had baseline EASI of 29.2 (11.2) and P-NRS of 7.1 (1.7). In patients with skin of colour, 79% (q4w, 19 of 24) and 83% (q2w, 19 of 23) maintained stable EASI 75 to week 152, while 86% (q4w, 12 of 14) and 67% (q2w, 8 of 12) maintained stable ≥ 4-point P-NRS improvement to week 104. Lebrikizumab was effective at week 16 across racial subgroups for the treatment of moderate-to-severe AD, with stable skin and itch responses in patients with skin of colour.