Chen Tai-Li, Huang Jing-Yang, Lin Hui-Yun, Chang Yun-Ting, Li Cheng-Yuan, Wei James Cheng-Chung
Department of Dermatology, Taipei Veterans General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming Chao Tung University, Taipei, Taiwan.
Department of Medical Research, Chung Shan Medical University Hospital, Taichung City, Taiwan; Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
J Am Acad Dermatol. 2025 May;92(5):1015-1023. doi: 10.1016/j.jaad.2024.12.025. Epub 2024 Dec 28.
The risk of major adverse cardiovascular events (MACEs) and venous thromboembolic events (VTEs) in patients with psoriatic disease receiving biologics is not fully understood.
This study aimed to investigate whether novel biologic therapies (interleukin 17 inhibitor [IL-17i], interleukin 12/23 inhibitor [IL-12/23i], and interleukin 23 inhibitor [IL-23i]) for biologic-naïve patients with psoriasis or psoriatic arthritis (PsA) are associated with differences in the risks of MACE and VTE compared with those with tumor necrosis factor inhibitors (TNFis).
An emulated target trial was designed by a nationwide cohort using data from the TriNetX Research Network. Biologic-naïve patients with psoriasis or PsA receiving biologics between 2014 and 2022 were enrolled. Treatment groups were determined by patients' first prescription of biologics. Three propensity-matched cohorts were established, namely, IL-17i versus TNFi, IL-12/23i versus TNFi, and IL-23i versus TNFi. The incidence rate and incidence rate ratios were estimated.
A total of 32,098 biologic-naïve patients with psoriasis or PsA treated with biologics were included. All enrollees were further categorized into 4 cohorts (20,314 in the TNFi cohort, 5073 in the IL-17i cohort, 3573 in the IL-12/23i cohort, and 3138 in the IL-23i cohort). No significant difference in the risks of MACE and VTE between biologics existed among patients with psoriatic disease. In the subgroup analyses for either psoriasis or PsA, no significant difference in the risks of MACE or VTE was noted among all comparisons in the subgroup. Among patients with preexisting hyperlipidemia and diabetes mellitus, the risks of MACE and VTE among patients using new biologics (IL-17i, IL-12/23i, or IL-23i) were lower than those using TNFi.
The data lack psoriasis severity.
Among patients with psoriasis or PsA, no significant risk differences in MACE and VTE were detected between those with IL-17i, IL-12/23i, and IL-23i and those with TNFi. These findings can serve as a reference to health care providers and patients when making clinical decisions, thereby also providing evidence for future pharmacovigilance research.
接受生物制剂治疗的银屑病患者发生主要不良心血管事件(MACE)和静脉血栓栓塞事件(VTE)的风险尚未完全明确。
本研究旨在调查初治的银屑病或银屑病关节炎(PsA)患者使用新型生物疗法(白细胞介素17抑制剂[IL-17i]、白细胞介素12/23抑制剂[IL-12/23i]和白细胞介素23抑制剂[IL-23i])与使用肿瘤坏死因子抑制剂(TNFis)相比,MACE和VTE风险是否存在差异。
利用TriNetX研究网络的数据,通过全国性队列设计了一项模拟目标试验。纳入2014年至2022年间初治的接受生物制剂治疗的银屑病或PsA患者。治疗组根据患者首次使用生物制剂的处方确定。建立了三个倾向匹配队列,即IL-17i与TNFi、IL-12/23i与TNFi、IL-23i与TNFi。估计发病率和发病率比。
共纳入32,098例初治的接受生物制剂治疗的银屑病或PsA患者。所有入组患者进一步分为4个队列(TNFi队列20,314例、IL-17i队列5073例、IL-12/23i队列3573例、IL-23i队列3138例)。银屑病患者中,不同生物制剂之间MACE和VTE风险无显著差异。在银屑病或PsA的亚组分析中,亚组内所有比较的MACE或VTE风险均无显著差异。在已有高脂血症和糖尿病的患者中,使用新型生物制剂(IL-17i、IL-12/23i或IL-23i)的患者发生MACE和VTE的风险低于使用TNFi的患者。
数据缺乏银屑病严重程度信息。
在银屑病或PsA患者中,IL-17i、IL-12/23i和IL-23i使用者与TNFi使用者之间在MACE和VTE方面未检测到显著的风险差异。这些发现可为医疗保健提供者和患者在做出临床决策时提供参考,也为未来的药物警戒研究提供证据。