Lebrikizumab provides stable skin response with no or minimal fluctuations for up to 2 years in patients with atopic dermatitis

Background: Lebrikizumab, a novel monoclonal antibody targeting interleukin-13, demonstrated a durable and deep response on skin and itch in patients treated for 104 weeks in recent phase III trials (ADvocate1, NCT04146363; ADvocate2, NCT04178967; ADjoin, NCT04392154). Objectives: To assess stability of response through 2 years of continuous lebrikizumab treatment in week 16 responders from ADvocate1 and ADvocate2 who continued the same treatment [lebrikizumab every 4 weeks (q4w), n = 99; lebrikizumab every 2 weeks (q2w), n = 82] in the long-term extension study ADjoin. Methods: Week 16 response was defined as the Investigator’s Global Assessment score of 0 or 1 with ≥ 2-point improvement from baseline, or ≥ 75% reduction in Eczema Area and Severity Index (EASI 75) without rescue medication. Stability was measured for EASI 75, EASI 90 and Pruritus Numeric Rating Scale (NRS) ≥ 3-point and ≥ 4-point improvement from baseline among week 16 responders who had achieved the specified endpoint at week 16. Stability was defined as maintenance of response for ≥ 80% of attended study visits from weeks 16 through 104 (ADjoin week 52). Observed data were analysed regardless of rescue medication or discontinuation from treatment. Results: With 104 weeks of continuous lebrikizumab treatment, 96% and 81% of week 16 responders receiving lebrikizumab q4w (91% and 79% for q2w) showed stable EASI 75 and EASI 90 responses, respectively. Similarly, 94% and 88% of responders receiving lebrikizumab q4w (89% and 87% for q2w) showed stable responses for Pruritus NRS ≥ 3-point and ≥ 4-point improvement, respectively. Conclusions: The majority of lebrikizumab week 16 responders maintained stable efficacy in measures of skin and itch during 2 years of ­treatment.