Efficacy of Lebrikizumab in Patients With Severe Atopic Dermatitis Who Would be Eligible for Treatment Based on the South Korean Reimbursement Criteria

Abstract

Background Lebrikizumab is approved to treat patients with moderate-to-severe atopic dermatitis (AD). Objectives This study evaluated the 16-week efficacy outcomes of lebrikizumab in adults and adolescents with severe AD in ADvocate trials who would be eligible for treatment based on South Korean reimbursement-like criteria. Methods This was a post-hoc analysis of pooled data from ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967). Patients were randomised 2:1 to receive lebrikizumab or placebo every 2 weeks. Two non-mutually exclusive subgroups were selected based on South Korean reimbursement-like criteria: Eczema Area and Severity Index (EASI) score >= 23, AD duration >= 3 years, and previous use of any systemic treatment (ST subgroup) or previous treatment with cyclosporine or methotrexate (CM subgroup). Week-16 outcomes were Investigator's Global Assessment score of 0 or 1 (IGA [0,1]) with >= 2-point improvement, >= 50%/75%/90% improvement in EASI score (EASI 50/75/90), Pruritus Numeric Rating Scale (NRS) >= 4-point improvement, and Dermatology Life Quality Index (DLQI) >= 4-point improvement. Response rates to lebrikizumab and placebo were analysed using Cochran-Mantel-Haenszel tests. Common risk differences and 95% confidence intervals were reported. Results The ST subgroup included 322 patients, and the CM subgroup included 111 patients. More lebrikizumab-treated than placebo-treated patients achieved outcome responses. Percentage differences in favour of lebrikizumab (p < 0.01) were: IGA (0,1): ST = 25.7% (18.2%-33.1%), CM = 20.8% (7.9%-33.7%); EASI 50: ST = 42.7% (32.5%-52.9%), CM = 36.9% (19.8%-54.0%); EASI 75: ST = 40.2% (31.4%-49.1%), CM = 33.3% (19.1%-47.5%); EASI 90: ST = 27.4% (20.3%-34.5%), CM = 22.1% (11.3%-32.8%); Pruritus NRS >= 4-point improvement: ST = 34.7% (26.7%-42.7%), CM = 26.7% (14.9%-38.4%); and DLQI >= 4-point improvement: ST = 44.2% (33.2%-55.2%), CM = 39.5% (20.2%-58.8%). Conclusions In this post-hoc, exploratory subgroup analysis, lebrikizumab improved AD skin and pruritus at week 16 in adults and adolescents who would be eligible for treatment based on South Korean reimbursement-like criteria.