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<p>Summary 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 (<i>N</i> = 2992) and two open-label extensions (OLEs; <i>N</i> = 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 [<CitationRef CitationID="CR1">1</CitationRef>] (Fig. <InternalRef RefID="Fig1">1</InternalRef>).</p>

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Summary of Research: Immunogenicity of Dupilumab in Adult and Pediatric Patients with Atopic Dermatitis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月29日

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  • Matthew P. Kosloski,
  • Ching-Ha Lai,
  • Michael A. Partridge,
  • Vanaja Kanamaluru,
  • Ashish Bansal,
  • Brad Shumel,
  • Marius Ardeleanu,
  • Hong Yan,
  • Christine Xu,
  • Ainara Rodríguez Marco,
  • Jing Xiao,
  • Faisal A. Khokhar,
  • Guy Gherardi,
  • Elisa Babilonia,
  • Bolanle Akinlade,
  • Albert Torri,
  • John D. Davis

摘要

Summary 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).