1. Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis
- Author
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Mohamed A. Kamal, Matthew P. Kosloski, Ching-Ha Lai, Michael A. Partridge, Manoj Rajadhyaksha, Vanaja Kanamaluru, Ashish Bansal, Arsalan Shabbir, Brad Shumel, Marius Ardeleanu, Susan M. Richards, Hong Yan, Christine R. Xu, Ainara Rodríguez-Marco, Jing Xiao, Faisal A. Khokhar, Guy Gherardi, Elisa Babilonia, Jennifer Maloney, Eric Mortensen, Bolanle Akinlade, Ned Braunstein, Neil Stahl, Albert Torri, John D. Davis, and A. Thomas DiCioccio
- Subjects
anti-drug antibody ,ADA ,atopic dermatitis ,dupilumab ,immunogenicity ,neutralizing antibody ,Immunologic diseases. Allergy ,RC581-607 - Abstract
BackgroundDevelopment of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to monoclonal antibodies may adversely impact pharmacokinetics, efficacy, and/or safety.ObjectiveTo describe incidence, titer, and persistence of dupilumab ADAs and NAbs, and their effects on pharmacokinetics, efficacy, and safety in patients with atopic dermatitis (AD).MethodsThis 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.ResultsTreatment-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, ≤3.7% had persistent responses,
- Published
- 2024
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