Three-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin)
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: 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.
Source: Dermatology and Therapy
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $7,400
Funders: Amgen, Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, AstraZeneca, Sanofi, Celgene, Regeneron Pharmaceuticals, Valeant Pharmaceuticals International, Dermira, Incyte, Concert Pharmaceuticals, Glenmark Pharmaceuticals, Astellas Pharma, Galderma, Sun Pharma, Bausch Health, LEO Pharma, EMD Serono, Sanofi Genzyme, UCB Pharma
OpenAlex ID: W7165114866
