P149 Efficacy of lebrikizumab at 16 weeks: pooled analyses from the ADvocate1 and ADvocate2 phase III trials in adolescent and older adult patients with moderate-to-severe atopic dermatitis

Abstract

Historically, atopic dermatitis (AD) was believed to primarily affect children. However, a recent meta-analysis of 17 studies reported that AD can affect people of all age groups, including adolescents and adults. Lebrikizumab, a high-affinity monoclonal antibody targeting interleukin-13, previously demonstrated clinical efficacy in patients with AD in phase III trials. We report 16-week efficacy outcomes of lebrikizumab monotherapy in adolescents and older adults with moderate-to-severe AD. Data were pooled from two randomized, double-blinded, placebo-controlled phase III trials, ADvocate1 and ADvocate2 (NCT04146363 and NCT04178967). Eligible patients were randomized 2 : 1 to subcutaneous lebrikizumab 250 mg (500-mg loading dose at baseline and week 2, followed by 250 mg every 2 weeks) or placebo every 2 weeks for 16 weeks. For adolescents (≥ 12–18 years, ≥ 40 kg) and older adults (≥ 60 years), week 16 efficacy analyses included proportions of patients achieving an Investigator’s Global Assessment score of 0 or 1 (IGA0/1) with ≥ 2-point improvement; ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI 75) and ≥ 4-point improvement in Pruritus Numerical Rating Scale (P-NRS4). Comparisons between treatment groups were performed using Cochran–Mantel–Haenszel tests. Data collected after use of rescue medication or discontinuation from lack of efficacy were imputed with nonresponder imputation; missing data were imputed with multiple imputation. Among adolescents, week 16 response rates for lebrikizumab (n = 67) vs. placebo (n = 35) were IGA0/1 with ≥ 2-point improvement from baseline, 47% vs. 14% (P < 0.01); EASI 75, 62% vs. 17% (P < 0.001) and P-NRS4, 49% vs. 13% (P < 0.01). Among older adults, week 16 response rates for lebrikizumab (n = 70) vs. placebo (n = 28) were IGA0/1, 34% vs. 11% (P = 0.02); EASI 75, 49% vs. 16% (P = 0.004) and P-NRS4, 45% vs. 12% (P = 0.004). These data suggest that lebrikizumab 250 mg every 2 weeks for 16 weeks is an efficacious treatment for adolescent and older adult patients with moderate-to-severe AD. Response rates were comparable with those of the overall ADvocate1/2 population previously reported.