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特诺雅单抗对代谢综合征状态下银屑病患者心血管代谢危险因素的影响:两项 3 期临床试验(ReSURFACE 1 和 ReSURFACE 2)的事后分析。

The Effect of Tildrakizumab on Cardiometabolic Risk Factors in Psoriasis by Metabolic Syndrome Status: Post Hoc Analysis of Two Phase 3 Trials (ReSURFACE 1 and ReSURFACE 2).

出版信息

J Drugs Dermatol. 2020 Aug 1;19(8):703-708. doi: 10.36849/JDD.2020.5337.

Abstract

Background: Metabolic syndrome (MetS) is the most prevalent comorbidity in psoriasis and increases the risk of cardiovascular disease, diabetes, and mortality. Assessment of impacts of biologic therapies on cardiometabolic risk factors are relatively limited. This study evaluated the effect of tildrakizumab on cardiometabolic risk factors in patients with moderate to severe plaque psoriasis and stratified by MetS status. Methods: In this post hoc analysis of reSURFACE 1/2, tildrakizumab 100 and 200 mg were continuously administered to patients with moderate to severe plaque psoriasis at weeks 0 and 4, and every 12 weeks thereafter. Mean and mean percent changes from baseline were assessed for fasting serum glucose, low/high-density lipoprotein-cholesterol, total cholesterol, triglyceride levels, body weight, and blood pressure at week 64/52 for reSURFACE 1 and 2, respectively, in patients with and without MetS. Results: A total of 369 patients in reSURFACE 1 and 2 received continuous tildrakizumab 100 mg and 330 received tildrakizumab 200 mg; 21.4% and 20.3% in reSURFACE 1 and 2, respectively, had MetS. At week 64/52, mean changes in cardiometabolic risk factors from baseline did not significantly differ regardless of MetS status. Numerically larger mean decreases in fasting glucose, triglycerides, and systolic blood pressure following tildrakizumab 100 mg and in systolic and diastolic blood pressure following tildrakizumab 200 mg were observed in patients with MetS relative to those without MetS. Conclusions: Changes in cardiometabolic disease risk factors following tildrakizumab treatment were limited. Risk factors were not increased in patients with MetS vs without MetS. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5337.

摘要

背景

代谢综合征(MetS)是银屑病最常见的合并症,增加了心血管疾病、糖尿病和死亡率的风险。评估生物疗法对心血管代谢危险因素的影响相对有限。本研究评估了替西单抗对中重度斑块状银屑病患者心血管代谢危险因素的影响,并按 MetS 状态进行了分层。

方法

在 reSURFACE 1/2 的这一事后分析中,替西单抗 100mg 和 200mg 分别在中重度斑块状银屑病患者的第 0 周和第 4 周连续给药,此后每 12 周给药一次。在 reSURFACE 1 和 2 中,分别在第 64 周和第 52 周评估空腹血清葡萄糖、低/高密度脂蛋白胆固醇、总胆固醇、甘油三酯水平、体重和血压相对于基线的平均值和平均值百分比变化,在有和没有 MetS 的患者中。

结果

reSURFACE 1 和 2 中共有 369 名患者接受了替西单抗 100mg 的连续治疗,330 名患者接受了替西单抗 200mg 的连续治疗;reSURFACE 1 和 2 中分别有 21.4%和 20.3%的患者患有 MetS。在第 64 周/第 52 周,无论 MetS 状态如何,心血管代谢危险因素相对于基线的平均变化均无显著差异。与没有 MetS 的患者相比,替西单抗 100mg 治疗后空腹血糖、甘油三酯和收缩压的平均下降幅度较大,替西单抗 200mg 治疗后收缩压和舒张压的平均下降幅度较大。

结论

替西单抗治疗后心血管疾病危险因素的变化有限。与没有 MetS 的患者相比,MetS 患者的危险因素没有增加。J 皮肤病学杂志。2020;19(8):doi:10.36849/JDD.2020.5337.

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