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Introduction <p>Selectively prescribing new medications to patients with severe disease can lead to channeling bias in observational studies. Potential for channeling upon label extension has not been described. The objective of this study was to describe dupilumab-treated patients with moderate-to-severe atopic dermatitis (AD) at initial United States Food and Drug Administration (FDA) approval for adults (March 2017) and at label extensions to adolescents (March 2019), children (May 2020), and young children (June 2022).</p> Methods <p>A cross-sectional study was conducted using Optum’s de-identified Clinformatics® Data Mart Database to describe baseline characteristics of patients with AD in the US who initiated dupilumab within 6 months of FDA approval or label extension.</p> Results <p>Dupilumab-treated patients with AD at initial approval, versus the most recent label update, had a higher prevalence of comorbid Type 2 inflammatory diseases (e.g., asthma: 33% versus 22%), a larger proportion of prior systemic immunosuppressant use (31% versus 5%), and more frequent dermatologist visits in the previous year (mean 6.1 versus 3.1 visits). Newly licensed adolescents and children had a greater burden of atopic comorbidities and a different pattern of prior AD treatment than adults.</p> Conclusion <p>Patients initiating dupilumab in March 2017 had markers of high disease burden, consistent with channeling. As the label extended, the population shifted toward the indicated moderate-to-severe phenotype. Channeling trends were difficult to assess given the well-established differences in comorbidities and treatment patterns in pediatric AD.</p>

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Characteristics of Dupilumab-Treated Patients with Atopic Dermatitis Over Time: A Cross-Sectional Assessment of Potential Channeling Bias upon Pediatric Label Extension

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月18日

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  • Julie Barberio,
  • Venkatesh Harikrishnan,
  • Shiyao Gao,
  • Andrea Marcus,
  • Sarah-Jo Sinnott

摘要

Introduction

Selectively prescribing new medications to patients with severe disease can lead to channeling bias in observational studies. Potential for channeling upon label extension has not been described. The objective of this study was to describe dupilumab-treated patients with moderate-to-severe atopic dermatitis (AD) at initial United States Food and Drug Administration (FDA) approval for adults (March 2017) and at label extensions to adolescents (March 2019), children (May 2020), and young children (June 2022).

Methods

A cross-sectional study was conducted using Optum’s de-identified Clinformatics® Data Mart Database to describe baseline characteristics of patients with AD in the US who initiated dupilumab within 6 months of FDA approval or label extension.

Results

Dupilumab-treated patients with AD at initial approval, versus the most recent label update, had a higher prevalence of comorbid Type 2 inflammatory diseases (e.g., asthma: 33% versus 22%), a larger proportion of prior systemic immunosuppressant use (31% versus 5%), and more frequent dermatologist visits in the previous year (mean 6.1 versus 3.1 visits). Newly licensed adolescents and children had a greater burden of atopic comorbidities and a different pattern of prior AD treatment than adults.

Conclusion

Patients initiating dupilumab in March 2017 had markers of high disease burden, consistent with channeling. As the label extended, the population shifted toward the indicated moderate-to-severe phenotype. Channeling trends were difficult to assess given the well-established differences in comorbidities and treatment patterns in pediatric AD.