Lebrikizumab reduced interference of itch on sleep at 52 weeks in patients with moderate-to- severe atopic dermatitis: pooled analysis of two phase 3 randomized controlled trials

Lebrikizumab (LEB) is a novel, high-affinity monoclonal antibody targeting interleukin-13. In identical Phase 3 trials, ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967), LEB reduced interference of itch on sleep at 16 weeks in patients with moderate-to-severe atopic dermatitis (AD). We report durability of LEB reduction in interference of itch on sleep over 52 weeks in ADvocate1&2. Analyses include Week 16 responders to induction with LEB 250mg every 2 weeks (LEB Q2W), defined as Investigator’s Global Assessment (0,1) with ≥2-point improvement or 75% improvement in Eczema Area and Severity Index without rescue medication, who were re-randomized to LEB Q2W or LEB 250mg every 4 weeks (LEB Q4W) maintenance through Week 52. Patients completed the 5-point Sleep-Loss Scale measuring the interference of itch on sleep in a daily eDiary. Mean weekly scores were calculated from the previous 7 days. In pooled ADvocate1&2, 231 patients received ≥1 LEB maintenance dose. The proportion of patients with ≥2-point improvement from baseline in Sleep-Loss Scale score at the start of maintenance (Week 16) was 46.9% and 50.2% in the LEB Q2W (N=79) and LEB Q4W (N=64) groups, which was sustained to Week 52 (53.8% and 56.3%, respectively). Mean change from baseline in Sleep- Loss Scale scores for the LEB Q2W (N=113) and LEB Q4W groups (N=118), respectively, was -1.43 and - 1.42 at Week 16 and -1.49 and 1.46 at Week 52. LEB showed a durable reduction in the interference of itch on sleep through 52 weeks in patients with AD who were responders to LEB 16-week induction treatment.