Lebrikizumab Provides Stable and Deep Long-Term Response with No/Minimal Fluctuations up to 3 Years in Patients with Moderate-to-Severe Atopic Dermatitis

Lebrikizumab provides lasting improvements in skin clearance and itch relief in patients with moderate-to-severe atopic dermatitis (AD). This analysis assessed long-term stability, depth of response, and flare incidence through 3 years in week 16 responders from ADvocate1 and ADvocate2 who continued maintenance lebrikizumab regimen (every 4 weeks [Q4W] or every 2 weeks [Q2W]) in the ADjoin extension study. Responders achieved either an Investigator’s Global Assessment (IGA) score of 0 or 1 with ≥ 2-point improvement or ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16, without rescue medication use. Long-term deep response was defined by skin and itch endpoints (3 years: IGA 0, ≥ 90% improvement from baseline in EASI [EASI 90], 100% improvement from baseline in EASI [EASI 100], absolute EASI score of ≤ 1 [EASI ≤ 1], Patient‐Oriented Eczema Measure [POEM] [0, 1], POEM itch [0, 1]; 2 years: Pruritus Numeric Rating Scale [0, 1]). Stability was defined as maintaining outcomes at ≥ 80% of attended visits between week 16 and week 152. Flares were evaluated via three definitions: any rescue therapy use, high-potency topical corticosteroids or systemic intervention, or adverse events due to AD exacerbation. After 152 weeks of continuous treatment, 88.6% (Q4W) and 80.0% (Q2W) of week 16 responders maintained EASI 90, while 64.3% (Q4W) and 68.8% (Q2W) maintained EASI 100. Most patients achieving EASI 90 or EASI 100 at week 16 maintained stable responses through week 152 (Q4W: 77.8% and 57.9%; Q2W: 81.1% and 63.6%, respectively). Among stable EASI 75 responders (Q4W), 72.8% did not experience any flare through week 152, with an incidence rate of 0.19 flares per patient-year (~1 flare every 5 patient-years). Improvements in itch outcomes were sustained over time and followed patterns similar to those observed for skin responses. Continuous lebrikizumab treatment through 3 years provided stable disease control in skin and itch symptoms, with infrequent flares experienced by week 16 responders with moderate-to-severe AD. Trial registration: ClinicalTrials.gov NCT04146363, NCT04178967, and NCT04392154. Atopic dermatitis is a long-lasting and unpredictable skin disease that causes red, itchy, and inflamed skin. Researchers wanted to know if lebrikizumab provided stable and deep response in patients with moderate-to-severe atopic dermatitis through 3 years and whether patients would experience fewer disease flares. Patients who responded after 16 weeks of lebrikizumab treatment participated in this study. Researchers assessed if lebrikizumab treatment maintained clear skin and itch control. Stability was defined as meeting response in at least 80% of check-ups; disease flares requiring additional treatment were also monitored. Most people who improved in the first 16 weeks continued to have clear skin and itch relief up to 3 years. Most people maintained stable skin and itch control with monthly dosing. Among these patients, most did not experience flares, and when they did occur, they were infrequent, approximately less than one flare per patient in 1 year on average. Lebrikizumab demonstrated stable, durable, and deep responses in patients with moderate-to-severe atopic dermatitis, resulting in skin clearance and substantially reduced itch, with few disease flares.