Randomized trials evaluate the immunogenicity of dupilumab in patients with atopic dermatitis, suggesting minimal impact on treatment efficacy and safety.
of the original article "Immunogenicity of Dupilumab in Adult and Pediatric Patients with Atopic Dermatitis." Dupilumab is a monoclonal antibody used to treat atopic dermatitis (AD) in patients 6 months and older. Antibody drugs can induce immunogenicity by activating patient's immune system to produce antidrug antibodies (ADAs). Some ADAs may impact drug's activity ("neutralizing antibodies" [NAbs]) and/or safety. In this study, we evaluated anti-dupilumab ADAs in patients with AD from seven randomized controlled trials (N = 2992) and two open-label extensions (OLEs; N = 2287). The highest proportion of patients with ADAs in any study was 9%, 16%, 5%, and 2% in adults, adolescents, children, and infants, respectively. In any trial, fewer than 1% of patients had high-titer ADAs and up to 5% had NAbs. With longer observation in OLEs, most high or moderate ADA titers decreased over time while patients continued dupilumab treatment. Except in some rare cases of high-titer ADAs, the pharmacokinetics, efficacy, and safety of dupilumab were similar between ADA-positive and ADA-negative patients. One patient with high-titer ADAs developed serum sickness and discontinued dupilumab. In conclusion, most dupilumab-treated patients across age groups did not develop ADAs. Most ADA-positive patients had low-titer, NAb-negative ADAs. Most ADA-positive patients benefited from continuing dupilumab treatment [1] (Fig. 1).
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Kosloski et al. (2026) studied this question.
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