College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, 08826, Republic of Korea.
Department of Pharmacy, College of Pharmacy and Institute of Pharmaceutical Sciences, CHA University, Pocheon-si, Gyeonggi, Republic of Korea.
Arthritis Res Ther. 2022 Aug 9;24(1):191. doi: 10.1186/s13075-022-02868-w.
Tumor necrosis factor (TNF) inhibitors use in patients with rheumatoid arthritis (RA) has raised safety concerns about cancer risk, but study results remain controversial. This largest nationwide study to date compared cancer risk in TNF inhibitor users to non-biologic disease-modifying anti-rheumatic drug (nbDMARD) users in Korean patients with RA.
Data on all the eligible patients diagnosed with RA between 2005 and 2016 were retrieved from the Korean National Health Information Database. The one-to-one matched patients consisted of the matched cohort. The risks for developing all-type and site-specific cancers were estimated using incidence and incidence rate (IR) per 1000 person-years. Adjusted hazard ratio (HR) and 95% confidence interval (CI) were estimated using a Cox regression model.
Of the 22,851 patients in the before matching cohort, 4592 patients were included in the matched cohort. Treatment with TNF inhibitors was consistently associated with a lower risk of cancer than in the nbDMARD cohort (IR per 1000 person-years, 6.5 vs. 15.6; adjusted HR, 0.379; 95% CI, 0.255-0.563). The adjusted HR (95% CI) was significantly lower in the TNF inhibitor cohort than the nbDMARD cohort for gastrointestinal cancer (0.432; 0.235-0.797), breast cancer (0.146; 0.045-0.474), and genitourinary cancer (0.220; 0.059-0.820).
The use of TNF inhibitors was not associated with an increased risk of cancer development, and rather associated with a lower cancer incidence in Korean patients with RA. Cautious interpretation is needed not to oversimplify the study results as cancer-protective effects of TNF inhibitors. A further study linking claims and clinical data is needed to confirm our results.
肿瘤坏死因子(TNF)抑制剂在类风湿关节炎(RA)患者中的应用引发了对癌症风险的安全担忧,但研究结果仍存在争议。这项迄今为止最大的全国性研究比较了 TNF 抑制剂使用者与韩国 RA 患者中生物性疾病修饰抗风湿药物(nbDMARD)使用者的癌症风险。
从韩国国家健康信息数据库中检索了 2005 年至 2016 年间所有符合条件的 RA 患者的数据。通过 1:1 匹配的患者组成匹配队列。使用发病率和发病率(IR)每 1000 人年计算所有类型和部位特异性癌症的风险。使用 Cox 回归模型估计调整后的危险比(HR)和 95%置信区间(CI)。
在未匹配队列的 22851 名患者中,有 4592 名患者纳入匹配队列。与 nbDMARD 队列相比,TNF 抑制剂治疗始终与癌症风险降低相关(IR 每 1000 人年,6.5 与 15.6;调整后的 HR,0.379;95%CI,0.255-0.563)。与 nbDMARD 队列相比,TNF 抑制剂队列的胃肠道癌(0.432;0.235-0.797)、乳腺癌(0.146;0.045-0.474)和泌尿生殖系统癌(0.220;0.059-0.820)的调整后 HR(95%CI)显著降低。
TNF 抑制剂的使用与癌症发展风险增加无关,反而与韩国 RA 患者的癌症发病率降低相关。需要谨慎解释,不要过于简化研究结果,认为 TNF 抑制剂具有抗癌作用。需要进一步的研究将索赔和临床数据联系起来,以确认我们的结果。