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Background <p>Deucravacitinib, a selective inhibitor of TYK2 kinase, has been recently approved for the treatment of moderate to severe plaque psoriasis. Although the safety of deucravacitinib has been observed in clinical trials, its safety in the real world remains to be fully understood.</p> Aim <p>The purpose of this study was to analyze post-marketing adverse events (AEs) associated with deucravacitinib using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) to better understand its safety in real-world conditions.</p> Method <p>This study performed a retrospective analysis of AEs associated with deucravacitinib from the FAERS database, spanning from the third quarter of 2022 to the second quarter of 2024. AEs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA, Version 27.0). Disproportionality analysis was conducted using several statistical methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker, and Bayesian Confidence Propagation Neural Network. Additionally, time-to-onset analyses and sensitivity analyses were performed to provide a comprehensive assessment.</p> Results <p>AE reports from 1573 individuals were analyzed, revealing a total of 2895 AEs. Most of these events occurred within the first month of treatment. The primary AEs were associated with skin and subcutaneous tissue disorders, as well as infections and infestations. The study confirmed several known common AEs, including acne (n = 172, ROR 75, PRR 70.61, EBGM 69.14, IC 6.11), folliculitis (n = 51, ROR 62.45, PRR 61.37, EBGM 60.25, IC 5.91), and herpes zoster (n = 18, ROR 6.46, PRR 6.43, EBGM 6.42, IC 2.68), and identified some unexpected AEs such as urticaria (n = 36, ROR, PRR 5.27, EBGM 5.27, IC 2.4), skin burning sensation (n = 42, ROR 21.84, PRR 21.54, EBGM 21.41, IC 4.42), and myalgia (n = 26, ROR 3.93, PRR 3.9, EBGM 3.9, IC 1.96).</p> Conclusion <p>Our study confirms the known AEs associated with deucravacitinib and identifies several potential AEs. These findings provide preliminary safety data for the practical use of deucravacitinib.</p>

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Real-world safety of deucravacitinib: insights from the Food and Drug Administration Adverse Event Reporting System

  • 期刊论文

  • 发表日期：

    2025年4月9日

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  • Kaidi Zhao,
  • Shengxiang Xiao,
  • Yang Zhao,
  • Chen Tu

摘要

Background

Deucravacitinib, a selective inhibitor of TYK2 kinase, has been recently approved for the treatment of moderate to severe plaque psoriasis. Although the safety of deucravacitinib has been observed in clinical trials, its safety in the real world remains to be fully understood.

Aim

The purpose of this study was to analyze post-marketing adverse events (AEs) associated with deucravacitinib using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) to better understand its safety in real-world conditions.

Method

This study performed a retrospective analysis of AEs associated with deucravacitinib from the FAERS database, spanning from the third quarter of 2022 to the second quarter of 2024. AEs were classified according to the Medical Dictionary for Regulatory Activities (MedDRA, Version 27.0). Disproportionality analysis was conducted using several statistical methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker, and Bayesian Confidence Propagation Neural Network. Additionally, time-to-onset analyses and sensitivity analyses were performed to provide a comprehensive assessment.

Results

AE reports from 1573 individuals were analyzed, revealing a total of 2895 AEs. Most of these events occurred within the first month of treatment. The primary AEs were associated with skin and subcutaneous tissue disorders, as well as infections and infestations. The study confirmed several known common AEs, including acne (n = 172, ROR 75, PRR 70.61, EBGM 69.14, IC 6.11), folliculitis (n = 51, ROR 62.45, PRR 61.37, EBGM 60.25, IC 5.91), and herpes zoster (n = 18, ROR 6.46, PRR 6.43, EBGM 6.42, IC 2.68), and identified some unexpected AEs such as urticaria (n = 36, ROR, PRR 5.27, EBGM 5.27, IC 2.4), skin burning sensation (n = 42, ROR 21.84, PRR 21.54, EBGM 21.41, IC 4.42), and myalgia (n = 26, ROR 3.93, PRR 3.9, EBGM 3.9, IC 1.96).

Conclusion

Our study confirms the known AEs associated with deucravacitinib and identifies several potential AEs. These findings provide preliminary safety data for the practical use of deucravacitinib.