EPI-PHARE, Scientific Interest Group in Epidemiology of Health Products, French National Agency for the Safety of Medicines and Health Products, French National Health Insurance, Saint-Denis, France.
Anti-Infective Evasion and Pharmacoepidemiology Team, INSERM UMR1018, School of Medicine Simone Veil, University Versailles Saint-Quentin-en-Yvelines, Paris-Saclay University, Montigny-Le-Bretonneux, France.
JAMA Netw Open. 2023 Nov 1;6(11):e2342006. doi: 10.1001/jamanetworkopen.2023.42006.
IMPORTANCE: Solid organ transplant recipients are at high risk of severe infection with SARS-CoV-2 compared with the general population. However, factors associated with COVID-19-related severity in this population are still insufficiently explored in the literature. OBJECTIVE: To examine which health conditions and immunosuppressive drugs for preventing graft rejection are associated with the risk of COVID-19-related hospitalization in solid organ transplant recipients. DESIGN, SETTING, AND PARTICIPANTS: Using the French National Health Data System, this cohort study assessed patients of any age who received transplants between their date of birth and entry into the cohort on February 15, 2020. The cohort was followed up between February 15, 2020, and July 31, 2022. EXPOSURES: Immunosuppressive drugs, including steroids, and health conditions (age, sex, and comorbidities). MAIN OUTCOMES AND MEASURES: The main outcome was hospitalization for COVID-19, defined by main diagnostic International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) codes. Factors associated with the outcome were identified with a nonconditional logistic regression. Confounding by indication was controlled using a multivariable model with adjustment for individual confounders. Each transplanted organ was examined separately. RESULTS: Overall, 60 456 participants (median [IQR] age, 59 [47-67] years; 63.7% male) were included in the study, of whom 41 463 (68.6%) had kidney transplants, 14 464 (23.9%) had liver transplants, 5327 (8.8%) had heart transplants, and 2823 (4.6%) had lung transplants. Among them, 12.7% of kidney transplant recipients, 6.4% of liver transplant recipients, 12.9% of heart transplant recipients, and 18.0% of lung transplant recipients were hospitalized for COVID-19. In kidney transplant recipients, steroids (adjusted odds ratio [AOR], 1.60; 95% CI, 1.49-1.73) and mycophenolic acid (AOR, 1.37; 95% CI, 1.25-1.51) were associated with a high risk of hospitalization. In liver transplant recipients, tacrolimus (AOR, 0.77; 95% CI, 0.61-0.98) was associated with a decreased risk, and steroids (AOR, 1.60; 95% CI, 1.38-1.86) and mycophenolic acid (AOR, 1.61; 95% CI, 1.37-1.90) were associated with an increased risk of hospitalizations. In heart transplant recipients, cyclosporine (AOR, 0.67; 95% CI, 0.47-0.94) was associated with a decreased risk, and steroids (AOR, 1.42; 95% CI, 1.11-1.82), mycophenolic acid (AOR, 1.29; 95% CI, 1.02-1.64), sirolimus (AOR, 2.71; 95% CI, 1.20-6.09), and everolimus (AOR, 1.24; 95% CI, 1.01-1.51) were associated with an increased risk of hospitalization. Only steroids (AOR, 1.72; 95% CI, 1.19-2.48) were associated with a high risk of COVID-19 hospitalization in lung transplant recipients. CONCLUSIONS AND RELEVANCE: This study suggests that mycophenolic acid, sirolimus, and steroids are associated with an increased risk of COVID-19-related hospitalization in solid organ transplant recipients. These results should be considered by clinicians treating transplant recipients and may help inform epidemic-related decisions for this population in the future.
重要性：与一般人群相比，实体器官移植受者感染 SARS-CoV-2 的严重感染风险很高。然而，文献中仍未充分探讨与该人群 COVID-19 相关严重程度相关的因素。
目的：研究哪些健康状况和预防移植物排斥的免疫抑制药物与实体器官移植受者 COVID-19 相关住院风险相关。
设计、设置和参与者：使用法国国家健康数据系统，本队列研究评估了在 2020 年 2 月 15 日出生日至队列纳入日之间接受过移植的任何年龄的患者。该队列在 2020 年 2 月 15 日至 2022 年 7 月 31 日之间进行了随访。
暴露：免疫抑制剂，包括类固醇，以及健康状况（年龄、性别和合并症）。
主要结果和测量：主要结果是 COVID-19 住院，通过主要诊断国际疾病分类和相关健康问题第十次修订（ICD-10）代码定义。使用非条件逻辑回归确定与结果相关的因素。通过个体化混杂因素调整的多变量模型控制混杂因素。分别检查每个移植器官。
结果：共有 60456 名参与者（中位数[IQR]年龄，59 [47-67] 岁；63.7%为男性）纳入研究，其中 41463 名（68.6%）接受了肾移植，14464 名（23.9%）接受了肝移植，5327 名（8.8%）接受了心脏移植，2823 名（4.6%）接受了肺移植。其中，12.7%的肾移植受者、6.4%的肝移植受者、12.9%的心脏移植受者和 18.0%的肺移植受者因 COVID-19 住院。在肾移植受者中，类固醇（调整后优势比[OR]，1.60；95%CI，1.49-1.73）和麦考酚酸（OR，1.37；95%CI，1.25-1.51）与住院风险增加相关。在肝移植受者中，他克莫司（OR，0.77；95%CI，0.61-0.98）与降低风险相关，而类固醇（OR，1.60；95%CI，1.38-1.86）和麦考酚酸（OR，1.61；95%CI，1.37-1.90）与住院风险增加相关。在心脏移植受者中，环孢素（OR，0.67；95%CI，0.47-0.94）与降低风险相关，而类固醇（OR，1.42；95%CI，1.11-1.82）、麦考酚酸（OR，1.29；95%CI，1.02-1.64）、西罗莫司（OR，2.71；95%CI，1.20-6.09）和依维莫司（OR，1.24；95%CI，1.01-1.51）与住院风险增加相关。只有类固醇（OR，1.72；95%CI，1.19-2.48）与肺移植受者 COVID-19 住院的高风险相关。
结论和相关性：本研究表明，麦考酚酸、西罗莫司和类固醇与实体器官移植受者 COVID-19 相关住院风险增加相关。这些结果应由治疗移植受者的临床医生考虑，并可能有助于为未来这一人群的疫情相关决策提供信息。
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