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Introduction <p>Deucravacitinib is a novel, highly selective tyrosine kinase 2 allosteric inhibitor recently approved for the treatment of moderate-to-severe psoriasis in adults, though post-marketing safety data remain limited.</p> Aim <p>The purpose of this study was to perform a post-marketing safety evaluation of deucravacitinib based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p> Method <p>This study collected adverse event (AE) reports of deucravacitinib as primary suspected drug in the FAERS database from the third quarter of 2022 to the fourth quarter of 2024. Four main methods of the disproportionality analysis, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker, were employed for signal detection. Potential risk signals were deemed significant only when all four algorithms simultaneously met their thresholds. The important medical event (IME) terms list was used to identify IMEs of deucravacitinib. Additionally, the Weibull distribution was used to evaluate the time-to-onset (TTO) characteristics.</p> Results <p>Thirty-nine preferred terms were identified as potential risk signals. The most commonly reported AE were acne, mouth ulceration and folliculitis. Sixteen AEs with potential risk signals not mentioned on the label were also identified, including urticaria, oral pain, oropharyngeal pain, swelling face, lip swelling, eye swelling, cellulitis, ear pain, pharyngeal swelling, Bell’s palsy, mouth swelling, cheilitis, mycobacterium tuberculosis complex test positive, facial paralysis, hepatitis A, and central nervous system (CNS) infection. Rhabdomyolysis, Bell’s palsy, facial paralysis, and CNS infection were identified as the IMEs associated with deucravacitinib in this study. The Weibull distribution indicated that the TTO characteristics of deucravacitinib-associated AEs followed an early failure type.</p> Conclusion <p>This study provides new safety data for deucravacitinib in real-world settings, uncovering previously unrecognized risks and identifying several IMEs. These findings have somewhat supplemented the safety data for deucravacitinib. Given the limitations&#xa0;of the FAERS database, further post-marketing safety surveillance studies on deucravacitinib remain necessary in the future.</p>

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Safety evaluation of deucravacitinib: a real-world analysis based on the FDA adverse event reporting system database

  • 期刊论文

  • 发表日期：

    2025年8月9日

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  • Haowen Tan,
  • Xiubi Chen,
  • Xuan Ou,
  • Ying Chen

摘要

Introduction

Deucravacitinib is a novel, highly selective tyrosine kinase 2 allosteric inhibitor recently approved for the treatment of moderate-to-severe psoriasis in adults, though post-marketing safety data remain limited.

Aim

The purpose of this study was to perform a post-marketing safety evaluation of deucravacitinib based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Method

This study collected adverse event (AE) reports of deucravacitinib as primary suspected drug in the FAERS database from the third quarter of 2022 to the fourth quarter of 2024. Four main methods of the disproportionality analysis, including reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker, were employed for signal detection. Potential risk signals were deemed significant only when all four algorithms simultaneously met their thresholds. The important medical event (IME) terms list was used to identify IMEs of deucravacitinib. Additionally, the Weibull distribution was used to evaluate the time-to-onset (TTO) characteristics.

Results

Thirty-nine preferred terms were identified as potential risk signals. The most commonly reported AE were acne, mouth ulceration and folliculitis. Sixteen AEs with potential risk signals not mentioned on the label were also identified, including urticaria, oral pain, oropharyngeal pain, swelling face, lip swelling, eye swelling, cellulitis, ear pain, pharyngeal swelling, Bell’s palsy, mouth swelling, cheilitis, mycobacterium tuberculosis complex test positive, facial paralysis, hepatitis A, and central nervous system (CNS) infection. Rhabdomyolysis, Bell’s palsy, facial paralysis, and CNS infection were identified as the IMEs associated with deucravacitinib in this study. The Weibull distribution indicated that the TTO characteristics of deucravacitinib-associated AEs followed an early failure type.

Conclusion

This study provides new safety data for deucravacitinib in real-world settings, uncovering previously unrecognized risks and identifying several IMEs. These findings have somewhat supplemented the safety data for deucravacitinib. Given the limitations of the FAERS database, further post-marketing safety surveillance studies on deucravacitinib remain necessary in the future.