Three-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin)

INTRODUCTION: We report efficacy and safety of lebrikizumab up to 152 weeks (W) of continuous treatment with/without topical corticosteroids in the ADjoin long-term extension study. METHODS: ADvocate1&2 W16 lebrikizumab responders (Eczema Area and Severity Index (EASI) 75 or Investigator's Global Assessment (IGA) 0/1 without rescue) were re-randomized 2:2:1 lebrikizumab (LEB) 250 mg Q2W, Q4W, or placebo (lebrikizumab withdrawal, not presented herein) to the 36W maintenance period before entering ADjoin. ADhere W16 lebrikizumab responders were re-randomized 2:1 LEBQ2W/Q4W upon entering ADjoin. Data are reported as observed for W16 lebrikizumab responders from ADvocate1&2 (N = 181) and ADhere (N = 86) who received treatment up to ADjoin W100 (152W/116W for ADvocate1&2/ADhere). The Supplement reports additional populations. RESULTS: In participants who achieved IGA 0/1 at W16, 84.0% (Q4W) and 82.9% (Q2W) from ADvocate1&2 maintained IGA 0/1 at W152; 91.7% and 86.7% from ADhere maintained response at W116. Among participants achieving EASI 75 at W16, 94.1% (Q4W) and 90.5% (Q2W) from ADvocate1&2 maintained EASI 75 at W152; 90.9% and 94.9% from ADhere maintained EASI 75 at W116. Most adverse events (AEs) were mild (29.2%) or moderate (33.3%) in severity; 3.7% reported serious AEs; 2.6% reported AEs leading to treatment discontinuation. CONCLUSION: Lebrikizumab maintained efficacy up to 3 years of continuous treatment in LEB 250 mg Q2W and Q4W W16 lebrikizumab per-protocol responders. The safety profile was consistent with previous studies. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04392154.