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<p>Since FDA approval in 2017, dupilumab has been used for atopic conditions, but age-related differences in reported adverse event patterns remain incompletely characterized. We hypothesized that specific categories of adverse events would demonstrate differential reporting patterns across pediatric, adult, and geriatric populations. A retrospective pharmacovigilance analysis was conducted using FAERS reports from 2017 to 2024. Reports were deduplicated and stratified into pediatric (0–17 years), adult (18–64 years), and geriatric (≥ 65 years) groups. Adverse events were analyzed using Proportional Reporting Ratios (PRR) and Reporting Odds Ratios (ROR) with 95% confidence intervals to detect age-specific disproportionality. Among 261,461 reports, dermatologic and injection site reactions were the most common across all ages. Pediatric patients exhibited higher reporting of systemic and immune-mediated reactions, including fever, sleep disturbances, urticaria, and vomiting (PRR 1.28–3.10; ROR 1.29–3.15). Geriatric patients disproportionately reported respiratory, musculoskeletal, and infectious events, such as dyspnea, pneumonia, COVID-19 infection, and arthralgia (PRR 1.66–6.21; ROR 1.68–6.38). Dupilumab’s adverse event reporting profile was broadly consistent across age groups, with identifiable differences in reporting patterns. These findings represent hypothesis-generating signals from a pharmacovigilance dataset and should not be interpreted as measures of incidence or causal risk.</p>

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Side effect profile of dupilumab in different age groups: pharmacovigilance study of the FAERS database

  • 期刊论文

  • 发表日期：

    2026年7月31日

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  • Robert Adler,
  • Isha Gandhi,
  • Jessica L. Feig

摘要

Since FDA approval in 2017, dupilumab has been used for atopic conditions, but age-related differences in reported adverse event patterns remain incompletely characterized. We hypothesized that specific categories of adverse events would demonstrate differential reporting patterns across pediatric, adult, and geriatric populations. A retrospective pharmacovigilance analysis was conducted using FAERS reports from 2017 to 2024. Reports were deduplicated and stratified into pediatric (0–17 years), adult (18–64 years), and geriatric (≥ 65 years) groups. Adverse events were analyzed using Proportional Reporting Ratios (PRR) and Reporting Odds Ratios (ROR) with 95% confidence intervals to detect age-specific disproportionality. Among 261,461 reports, dermatologic and injection site reactions were the most common across all ages. Pediatric patients exhibited higher reporting of systemic and immune-mediated reactions, including fever, sleep disturbances, urticaria, and vomiting (PRR 1.28–3.10; ROR 1.29–3.15). Geriatric patients disproportionately reported respiratory, musculoskeletal, and infectious events, such as dyspnea, pneumonia, COVID-19 infection, and arthralgia (PRR 1.66–6.21; ROR 1.68–6.38). Dupilumab’s adverse event reporting profile was broadly consistent across age groups, with identifiable differences in reporting patterns. These findings represent hypothesis-generating signals from a pharmacovigilance dataset and should not be interpreted as measures of incidence or causal risk.