Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis.

ABSTRACT:

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

SUBMITTER: Kamal MA 

PROVIDER: S-EPMC11586717 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature