학술논문

Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study.
Document Type
article
Source
Dermatology and therapy. 13(7)
Subject
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
Language
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