Xu Yuanyuan, Liu Xinjin, Guo Linghong, Jiang Xian
Department of Dermatology, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.
Laboratory of Dermatology, Clinical Institute of Inflammation and Immunology, Frontiers Science Center for Disease-Related Molecular Network, West China Hospital, Sichuan University, Chengdu, 610041, People's Republic of China.
Clin Cosmet Investig Dermatol. 2025 May 5;18:1121-1135. doi: 10.2147/CCID.S439643. eCollection 2025.
Apremilast and deucravacitinib are oral small-molecule inhibitors approved for the treatment of psoriasis, each with the potential to fill unmet needs among psoriasis patients. Investigating their adverse event (AE) profiles with post-marketing data is essential for optimizing patient care.
We analyzed AE reports from the FDA Adverse Event Reporting System (FAERS) database during Q1 2014 to Q4 2023. Disproportionality and Bayesian analyses were utilized to compare safety signals.
A total of 95,524 and 754 AE reports associated with apremilast and deucravacitinib were retrieved, respectively. Apremilast was more prevalent to cause gastrointestinal AEs such as diarrhea and nausea, as well as psoriasis recurrence and nervous system disorders like headache. Deucravacitinib showed stronger associations with cutaneous AEs, including acne, folliculitis, pruritus, rash, and erythema, along with oral conditions. AEs not previously documented on drug labels, such as sinus headache and multiple allergies for apremilast, and acneiform dermatitis and rosacea for deucravacitinib, were identified. Female patients were exposed to a higher risk for skin-related AEs when using deucravacitinib.
Our study offers valuable real-world insights into the safety profiles of apremilast and deucravacitinib. The observed sex differences in adverse events associated with apremilast and deucravacitinib require further investigation in real-world and clinical settings.
阿普米司特和氘可来昔替尼是已获批用于治疗银屑病的口服小分子抑制剂，二者均有潜力满足银屑病患者未被满足的需求。利用上市后数据研究它们的不良事件（AE）概况对于优化患者护理至关重要。
我们分析了2014年第一季度至2023年第四季度美国食品药品监督管理局不良事件报告系统（FAERS）数据库中的AE报告。采用不成比例分析和贝叶斯分析来比较安全信号。
分别检索到95524份和754份与阿普米司特和氘可来昔替尼相关的AE报告。阿普米司特更常引起腹泻、恶心等胃肠道AE，以及银屑病复发和头痛等神经系统疾病。氘可来昔替尼与皮肤AE的关联更强，包括痤疮、毛囊炎、瘙痒、皮疹和红斑，以及口腔疾病。还发现了药物标签上先前未记录的AE，如阿普米司特的鼻窦头痛和多种过敏，以及氘可来昔替尼的痤疮样皮炎和酒渣鼻。使用氘可来昔替尼时，女性患者发生皮肤相关AE的风险更高。
我们的研究为阿普米司特和氘可来昔替尼的安全性概况提供了有价值的真实世界见解。阿普米司特和氘可来昔替尼相关不良事件中观察到的性别差异需要在真实世界和临床环境中进一步研究。
