1. Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study
- Author
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Paller, Amy S, Flohr, Carsten, Eichenfield, Lawrence F, Irvine, Alan D, Weisman, Jamie, Soung, Jennifer, Pinto Correia, Ana, Natalie, Chitra R, Rodriguez Capriles, Claudia, Pierce, Evangeline, Reifeis, Sarah, Gontijo Lima, Renata, Armengol Tubau, Clara, Laquer, Vivian, and Weidinger, Stephan
- Subjects
Moderate-to-severe atopic dermatitis ,Pediatric ,Efficacy ,Depression ,Clinical Trials and Supportive Activities ,Clinical Sciences ,Evaluation of treatments and therapeutic interventions ,Adolescents ,Lebrikizumab ,Brain Disorders ,Mental Health ,Good Health and Well Being ,Clinical Research ,IL-13 ,6.1 Pharmaceuticals ,Patient Safety ,Safety - Abstract
IntroductionAtopic dermatitis (AD) is a chronic inflammatory skin disorder with limited treatment options for adolescents with moderate-to-severe disease. Lebrikizumab, a monoclonal antibody targeting interleukin (IL)-13, demonstrated clinical benefit in previous Phase 3 trials: ADvocate1 (NCT04146363), ADvocate2 (NCT04178967), and ADhere (NCT04250337). We report 52-week safety and efficacy outcomes from ADore (NCT04250350), a Phase 3, open-label study of lebrikizumab in adolescent patients with moderate-to-severe AD. The primary endpoint was to describe the proportion of patients who discontinued from study treatment because of adverse events (AEs) through the last treatment visit.MethodsAdolescent patients (N = 206) (≥ 12 to
- Published
- 2023