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
Adolescents ,Efficacy ,IL-13 ,Lebrikizumab ,Moderate-to-severe atopic dermatitis ,Safety ,Depression ,Mental Health ,Clinical Research ,Pediatric ,Patient Safety ,Clinical Trials and Supportive Activities ,Brain Disorders ,Evaluation of treatments and therapeutic interventions ,6.1 Pharmaceuticals ,Good Health and Well Being ,Clinical Sciences - 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