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COVID-19 治疗药物在炎性风湿病患者中的应用:世界卫生组织药物警戒数据库分析的结果。

COVID-19 in DMARD-treated patients with inflammatory rheumatic diseases: Insights from an analysis of the World Health Organization pharmacovigilance database.

机构信息

Department of Internal Medicine, Amiens-Picardie University Medical Center, Amiens, France.

RECIF, Amiens-Picardie University Medical Center, Amiens, France.

出版信息

Fundam Clin Pharmacol. 2022 Feb;36(1):199-209. doi: 10.1111/fcp.12695. Epub 2021 May 25.

Abstract

BACKGROUND

To determine whether the use of disease-modifying antirheumatic drugs (DMARDs) is linked to the risk of COVID-19 among patients with inflammatory rheumatic diseases (IRDs).

METHODS

We performed a disproportionality analysis of the World Health Organization pharmacovigilance database between January 1, 2020, and June 10, 2020. The frequency of COVID-19 reports for all DMARD classes identified was compared with that for all other reports for all other drugs and quoted as the reporting odds ratio (ROR) (95% confidence interval [CI]).

RESULTS

Among 980,446 individual case-safety reports voluntarily recorded in the database, 398 identified COVID-19 in DMARD-treated patients with IRDs. There were 177 (44.5%) patients with rheumatoid arthritis (RA), 120 (30.1%) with ankylosing spondylitis (AS), 93 (23.4%) with psoriatic arthritis (PsA), and 8 (2.0%) with juvenile idiopathic arthritis. Most of the cases of COVID-19 occurred in patients taking anti-TNF agents (84.2%), resulting in a significant disproportionality signal (ROR [95% CI]: 8.31 [7.48-9.23]) - particularly in patients with RA, AS or PsA. A significant inverse disproportionality was found for the anti-IL-6 agent tocilizumab (ROR [95% CI]: 0.12 [0.02-0.88]) and JAK inhibitors (ROR [95% CI]: 0.33 [0.19-0.58]) in patients with RA - suggesting that these two drug classes are safer in the context of RA.

CONCLUSION

Our results are in line with the literature on a potentially better safety profile for anti-IL-6 agents and JAK inhibitors. The WHO pharmacovigilance data suggest that COVID-19 is significantly more frequent in patients with IRDs treated with TNF inhibitors.

摘要

背景

为了确定在患有炎症性风湿病(IRD)的患者中,使用疾病修饰抗风湿药物(DMARDs)是否与 COVID-19 风险相关。

方法

我们对 2020 年 1 月 1 日至 2020 年 6 月 10 日期间世界卫生组织药物警戒数据库进行了不相称性分析。比较了所有 DMARD 类别的 COVID-19 报告频率与所有其他药物的所有其他报告频率,并将其表示为报告比值比(ROR)(95%置信区间[CI])。

结果

在数据库中自愿记录的 980,446 例个体病例安全报告中,有 398 例报告了接受 DMARD 治疗的 IRD 患者的 COVID-19。其中 177 例(44.5%)为类风湿关节炎(RA)患者,120 例(30.1%)为强直性脊柱炎(AS)患者,93 例(23.4%)为银屑病关节炎(PsA)患者,8 例(2.0%)为幼年特发性关节炎患者。大多数 COVID-19 病例发生在接受抗 TNF 药物治疗的患者中(84.2%),这导致了显著的不相称性信号(ROR [95%CI]:8.31 [7.48-9.23])-特别是在 RA、AS 或 PsA 患者中。在 RA 患者中,抗 IL-6 药物托珠单抗(ROR [95%CI]:0.12 [0.02-0.88])和 JAK 抑制剂(ROR [95%CI]:0.33 [0.19-0.58])的反向显著不相称,这表明这两类药物在 RA 情况下更安全。

结论

我们的结果与抗 IL-6 药物和 JAK 抑制剂具有潜在更好安全性的文献一致。世界卫生组织药物警戒数据表明,在接受 TNF 抑制剂治疗的 IRD 患者中,COVID-19 更为常见。

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