Long-Term Efficacy and Safety of Lebrikizumab Is Maintained in Patients With Moderate-to-Severe Atopic Dermatitis: Results Up to 3 Years From ADjoin

Introduction: We report efficacy and safety of lebrikizumab (LEB) in long-term extension study ADjoin (NCT04392154) following up to 152 Weeks (W) of continuous LEB treatment with/without TCS. Methods: Patients in ADvocate1&2 who achieved per-protocol response (EASI 75 or IGA 0/1 without rescue) following 16W of LEB treatment were re-randomized 2:2:1 to LEB250mg Q2W, LEB250mg Q4W, or placebo (LEB withdrawal). Patients who completed W52 of ADvocate1&2 could enroll in ADjoin. Patients who completed 16W of ADhere could enroll into ADjoin; per-protocol LEB responders were randomized 2:1 to LEB250mg Q2W or Q4W. Intermittent use of topicals was allowed in ADvocate1&2 W16–52, topicals and short-term systemics were allowed in ADjoin. Data are reported for W16 LEB responders originating from ADvocate1&2 (N=181) and ADhere (N=86) who received LEB250mg Q2W or Q4W in ADjoin. Efficacy outcomes were assessed based on all collected data (as observed analysis) up to W100 of ADjoin (total 152W and 116W of LEB treatment for patients from ADvocate1&2 and ADhere, respectively). Safety was reported from ADjoin enrollment up to the data cut-off April 24, 2024. Results: In patients from ADvocate1&2, at W152 IGA 0/1 was maintained by 82.9% (34/41; Q2W) and 84.0% (42/50; Q4W) and EASI 75 was maintained by 90.5% (57/63; Q2W) and 94.1% (64/68; Q4W) of patients. In patients from ADhere, at W116 IGA 0/1 was maintained by 86.7% (26/30; Q2W) and 91.7% (11/12; Q4W) and EASI 75 was maintained by 94.9% (37/39; Q2W) and 90.9% (20/22; Q4W) of patients. EASI 90 was reported by 79.4% (50/63; Q2W) and 86.8% (59/68; Q4W) of ADvocate1&2 patients at W152 and 84.6% (33/39; Q2W) and 86.4% (19/22; Q4W) of ADhere patients at W116. During 100Ws of ADjoin, most adverse events (AE) reported were mild (29.2%, 78/267) or moderate (33.3%, n=89) in severity. Serious AEs were reported by 4.1% (n=11) of patients. There was one death due to natural causes in the ADhere Q2W arm. AEs leading to treatment discontinuation were reported by 2.6% (n=7) of patients. Conclusion: Efficacy outcomes were maintained long-term, up to 3 years of continuous LEB treatment, in both LEB250mg Q2W and Q4W arms. The safety profile of LEB in ADjoin was consistent with previous LEB studies in patients with moderate-to-severe AD.