BACKGROUND: Development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to monoclonal antibodies may adversely impact pharmacokinetics, efficacy, and/or safety. OBJECTIVE: To describe incidence, titer, and persistence of dupilumab ADAs and NAbs, and their effects on pharmacokinetics, efficacy, and safety in patients with atopic dermatitis (AD). METHODS: This analysis included seven phase 3 randomized, placebo-controlled (N=2,992) and two long-term open-label extension (N=2,287) trials of subcutaneous dupilumab in adults and pediatric patients with moderate-to-severe AD. ADA, NAb, and dupilumab concentration in serum were assessed using validated immunoassays. ADA impacts on efficacy (EASI) and safety were assessed. RESULTS: Treatment-emergent ADAs were observed in up to 8.6% (aged >/=18 years), 16.0% (12-17 years), 5.3% (6-11 years), and 2.0% (6 months to 5 years) dupilumab-treated patients. Among dupilumab-treated patients, /=10,000), and
Kamal M A, Kosloski M P, Lai C H, Partridge M A, Rajadhyaksha M, Kanamaluru V, Bansal A, Shabbir A, Shumel B, Ardeleanu M, Richards S M, Yan H, Xu C R, Rodriguez-Marco A, Xiao J, Khokhar F A, Gherardi G, Babilonia E, Maloney J, Mortensen E, Akinlade B, Braunstein N, Stahl N, Torri A, Davis J D, and DiCioccio A T. (2024) Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis. Front Immunol 15():1466372 . [article]