Rhumatologie, Hôpital Purpan, Toulouse III Université, Toulouse, France.
Rhumatologie, Hôpital Pellegrin, Bordeaux Université, Bordeaux, France.
RMD Open. 2019 Jan 24;5(1):e000763. doi: 10.1136/rmdopen-2018-000763. eCollection 2019.
The objective was to investigate the short-term risk of major adverse cardiovascular events (MACEs) or congestive heart failure (CHF) in patients with psoriatic arthritis (PsA) or psoriasis initiating a biological therapy.
Screening for the study was carried out using MEDLINE, Cochrane and Embase, from the inception of the database to December 2017. Randomised controlled trials (RCTs) of anti-tumour necrosis factor (TNF), anti-interleukin (IL)12/23, anti-IL23 and anti-IL17 agents for the treatment of PsA or psoriasis were included. Two investigators independently extracted MACEs or CHF data reported during the placebo-controlled phase. The primary outcome measures were the incidence of MACEs or CHF.
Of 753 references screened, 62 articles were selected, and 12 articles were added by manual searches. Accordingly 77 RCTs were included in the meta-analysis (MA) (10 174 patient-years (P-Y)). No significant difference was observed in MACE incidences in patients receiving anti-TNF, anti-IL12/23, anti-IL23 or anti-IL17 agents in comparison to the placebo. However, 10 MACEs were observed in the anti-IL12/23 group (1150 P-Y) compared with 1 in the placebo group (652 P-Y), with 0.01 -0.00 to 0.02 event/P-Y risk difference, which is not statistically significant. This trend was not observed in the anti-IL23 group. No significant difference was observed in CHF incidence in patients receiving biological agents in comparison to placebo.
This MA of 77 RCTs did not reveal any significant change in the short-term risk of MACE or CHF in patients with PsA or psoriasis initiating a biological therapy.
本研究旨在探究开始接受生物疗法治疗的银屑病关节炎(PsA)或银屑病患者发生主要不良心血管事件(MACE)或充血性心力衰竭(CHF)的短期风险。
通过检索 MEDLINE、Cochrane 和 Embase 数据库,我们对从建库至 2017 年 12 月期间发表的研究进行了筛选。纳入了评估抗肿瘤坏死因子(TNF)、抗白细胞介素(IL)12/23、抗 IL23 和抗 IL17 制剂治疗 PsA 或银屑病的随机对照试验(RCT)。两名研究者独立提取安慰剂对照阶段报告的 MACE 或 CHF 数据。主要结局指标为 MACE 或 CHF 的发生率。
在筛选出的 753 篇参考文献中,有 62 篇文章入选,另外通过手工检索又添加了 12 篇文章。因此,共有 77 项 RCT 纳入荟萃分析(MA)(10174 患者年)。与安慰剂相比,接受抗 TNF、抗 IL12/23、抗 IL23 或抗 IL17 制剂治疗的患者发生 MACE 的风险无显著差异。然而,在接受抗 IL12/23 制剂治疗的患者中(1150 患者年)观察到 10 例 MACE,而安慰剂组仅观察到 1 例(652 患者年),风险差异为 0.01-0.00 至 0.02 事件/患者年,无统计学意义。这种趋势在抗 IL23 组中并未观察到。与安慰剂相比,接受生物制剂治疗的患者发生 CHF 的风险无显著差异。
这项纳入 77 项 RCT 的 MA 研究并未发现开始接受生物疗法治疗的 PsA 或银屑病患者发生 MACE 或 CHF 的短期风险有显著变化。