维奴奇珠单抗III期试验12周诱导期内选定的不良事件：一项探索性事后分析。
完整摘要 · 中文译文
目的：本研究旨在探讨vunakizumab对中重度斑块状银屑病患者不良事件（AEs）的影响。 方法：本探索性事后分析使用了III期试验（NCT04839016）的数据。共纳入690例患者。主要结局为12周诱导治疗期间任何AE的发生情况。 结果：诱导期间任何AE的发生率为69.9%。两组之间任何AE的发生率未见显著差异[风险差（RD）：-2.6%；95%置信区间（CI）：-9.8%至4.6%]。敏感性分析显示，vunakizumab不是任何AE发生的独立影响因素[比值比（OR）：0.828；95% CI：0.574至1.193；P = 0.311]。在系统器官分类（SOC）层面，检查、代谢和营养障碍、感染和寄生虫病以及皮肤和皮下组织疾病的发生率分别为31.9%、26.7%、18.0%和14.6%。在首选术语（PT）层面，高尿酸血症的发生率为11.3%，肝酶升高为7.1%，注射部位反应为5.1%。在SOC层面，vunakizumab组皮肤和皮下组织疾病的发生率低于安慰剂组（RD：-6.2%；95% CI：-12.1%至-0.3%）。在PT层面，vunakizumab组注射部位反应的发生率高于安慰剂组（RD：4.3%；95% CI：1.4%至7.3%）。值得注意的是，在排除银屑病加重后，vunakizumab与皮肤和皮下组织疾 皮肤疾病不再具有显著性。 结论：在中重度斑块状银屑病患者中，乌那奇尤单抗与任何不良事件（AE）或大多数特定AE类别的发生无显著相关性，而乌那奇尤单抗与注射部位反应的可能性较高以及皮肤和皮下组织疾病的可能性较低相关。观察到的皮肤和皮下组织疾病发生率较低可能主要反映银屑病控制改善，而非乌那奇尤单抗的特定安全性获益。 临床试验注册：https://clinicaltrials.gov/，标识号NCT04839016。
完整摘要 · 英文原文
OBJECTIVE: This study aimed to investigate the impact of vunakizumab on adverse events (AEs) in patients with moderate-to-severe plaque psoriasis. METHODS: This exploratory post-hoc analysis used data from a phase III trial (NCT04839016). A total of 690 patients were included. The primary outcome was any AE occurrence during the 12-week induction treatment period. RESULTS: The incidence of any AE during the induction period was 69.9%. No significant difference in the incidence of any AE was observed between the two groups [risk difference (RD): -2.6%; 95% confidence interval (CI): -9.8% to 4.6%]. Sensitivity analyses showed that vunakizumab was not an independent influencing factor for the occurrence of any AE [odds ratio (OR): 0.828; 95% CI: 0.574 to 1.193; P = 0.311]. At the system organ class (SOC) level, investigations, metabolic and nutritional disorders, infectious and parasitic diseases, and skin and subcutaneous tissue diseases had incidences of 31.9%, 26.7%, 18.0%, and 14.6%, respectively. At the preferred term (PT) level, incidences were 11.3% for hyperuricemia, 7.1% for elevated liver enzymes, and 5.1% for injection site reaction. At the SOC level, the incidence of skin and subcutaneous tissue diseases was lower in the vunakizumab group than in the placebo group (RD: -6.2%; 95% CI: -12.1% to -0.3%). At the PT level, the incidence of injection site reaction was higher in the vunakizumab group than in the placebo group (RD: 4.3%; 95% CI: 1.4% to 7.3%). Notably, after excluding psoriasis exacerbation, the association between vunakizumab and skin and subcutaneous tissue diseases was no longer significant. CONCLUSION: Vunakizumab is not significantly associated with the occurrence of any AE or most selected AE categories in patients with moderate-to-severe plaque psoriasis, whereas vunakizumab is associated with a higher likelihood of injection site reaction and a lower likelihood of skin and subcutaneous tissue diseases. The observed lower incidence of skin and subcutaneous tissue diseases may largely reflect improved control of psoriasis rather than a specific safety benefit of vunakizumab. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT04839016.