Sun Yan, Yang Shihao
H. Milton Stewart School of Industrial and Systems Engineering, Georgia Institute of Technology, 755 Ferst Dr NW, Atlanta, 30318, Georgia, USA.
medRxiv. 2024 Dec 5:2024.12.03.24318450. doi: 10.1101/2024.12.03.24318450.
Although immune checkpoint inhibitors have illustrated strong benefits in patient survival and have been widely acknowledged in treating lung cancer, they may be subject to increased risk of immune-related adverse effects (irAEs). Although existing literature have studied the mechanisms of irAEs of immunotherapy, it is difficult to quantify such effect, especially at a large-scale real-world population level. In this paper, the autoimmune-related risk of multiple immune checkpoint inhibitors is compared with that of chemotherapy based on Medicaid and CHIP TAF (T-MSIS Analytic File) data of over 100,000 patient samples from 2012 to 2018. Results show that the irAEs of immunotherapy is significantly higher than chemotherapy in both unadjusted and adjusted samples from the dataset. Analysis on subpopulation and specific disease types further shows that certain immunotherapy treatments are associated with higher risk of irAEs, and the risk of certain autoimmune diseases may vary. We also illustrate the robustness of our conclusion through additional sensitivity analysis, confirming the necessity of keeping track of autoimmune side effects of immune checkpoint inhibitors for medicine researchers. Our methods are also available to evaluate effectiveness and side effects of novel therapies at a large-scale population level.
尽管免疫检查点抑制剂已在患者生存方面显示出显著益处,并在肺癌治疗中得到广泛认可,但它们可能会增加免疫相关不良反应(irAEs)的风险。尽管现有文献已经研究了免疫治疗irAEs的机制,但难以量化这种影响,尤其是在大规模真实世界人群层面。在本文中,基于2012年至2018年来自超过10万份患者样本的医疗补助和儿童健康保险计划TAF(T-MSIS分析文件)数据,对多种免疫检查点抑制剂与化疗的自身免疫相关风险进行了比较。结果表明,在该数据集未经调整和调整后的样本中,免疫治疗的irAEs均显著高于化疗。对亚组和特定疾病类型的分析进一步表明,某些免疫治疗与更高的irAEs风险相关,且某些自身免疫性疾病的风险可能有所不同。我们还通过额外的敏感性分析说明了我们结论的稳健性,证实了医学研究人员跟踪免疫检查点抑制剂自身免疫副作用的必要性。我们的方法也可用于在大规模人群层面评估新疗法的有效性和副作用。