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

Background 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. Objective The purpose of this study was to perform a post-marketing safety evaluation of deucravacitinib base on the Food and Drug Administration Adverse Event Reporting System (FAERS). Mothed Adverse events (AEs) due to deucravacitinib from 2022Q3 to 2024Q4 identified as the primary suspect were screened. 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. 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 39 preferred terms (PTs) were identified as potential risk signals. The most commonly reported PT were acne, mouth ulceration and folliculitis. 16 PTs with potential risk signals not mentioned on the label were also identified, including urticaria, oral pain, oropharyngeal pain, swelling face, lip swelling, and others. Rhabdomyolysis, Bell’s palsy, facial paralysis, and central nervous system infection were the IMEs of deucravacitinib. The Weibull distribution indicated that the TTO characteristics of deucravacitinib-associated AEs followed an early failure type. Conclusion This study provides preliminary safety data for deucravacitinib in the real world, confirming some known AEs, uncovering some underlying risks and identifying several IMEs. Further post-marketing safety surveillance studies on deucravacitinib remain necessary in the future.