Karlqvist Sara, Sachs Michael C, Eriksson Carl, Cao Yang, Montgomery Scott, Ludvigsson Jonas F, Olén Ola, Halfvarson Jonas
Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
Am J Gastroenterol. 2024 Dec 1;119(12):2480-2492. doi: 10.14309/ajg.0000000000002961. Epub 2024 Jul 12.
We aimed to assess the risk of serious infection in patients with inflammatory bowel disease (IBD) treated with vedolizumab compared with those treated with anti-tumor necrosis factors (TNF) and the general population.
In this Swedish cohort study, treatment episodes were identified from nationwide health registers. We used Cox regression with propensity score-matched cohorts to estimate hazard ratios (HRs) for incident serious infections, defined as infections requiring hospital admission.
During 1,376 treatment episodes in Crohn's disease, the rate of serious infections per 100 person-years (PY) was 5.18 (95% CI = 3.98-6.63) with vedolizumab vs 3.54 (95% CI = 2.50-4.85) with anti-TNF; HR = 1.72 (95% CI = 1.12-2.65), partly explained by more gastrointestinal infections. Compared with the rate of 0.75/100 PY (95% CI = 0.59-0.92) in a matched general population cohort, vedolizumab demonstrated higher risk (HR = 7.00; 95% CI = 5.04-9.72). During 1,294 treatment episodes in ulcerative colitis, the corresponding rates were 3.74/100 PY (95% CI = 2.66-5.11) with vedolizumab vs 3.42/100 PY (95% CI = 2.31-4.89) with anti-TNF; HR = 0.80 (95% CI = 0.47-1.36) during the initial 1.1 years and HR = 2.03 (95% CI = 0.65-6.32) after 1.1 years (truncated due to nonproportional hazards). Pneumonia accounted for 40% of all infections among anti-TNF, whereas no case was observed among vedolizumab episodes. Compared with the rate of 0.69/100 PYs (95% CI = 0.53-0.87) in a matched general population cohort, vedolizumab showed an HR of 5.45 (95% CI = 3.67-8.11).
Vedolizumab was associated with increased risks of serious infections compared with anti-TNF in Crohn's disease but not in ulcerative colitis. Nonetheless, the panorama of serious infections seemed to differ between the drugs. Our findings underscore the importance of clinical awareness of infections and the safety profile of the 2 therapies.
我们旨在评估与接受抗肿瘤坏死因子（TNF）治疗的患者及普通人群相比，接受维多珠单抗治疗的炎症性肠病（IBD）患者发生严重感染的风险。
在这项瑞典队列研究中，从全国健康登记处识别治疗事件。我们使用Cox回归及倾向评分匹配队列来估计严重感染（定义为需要住院治疗的感染）的风险比（HRs）。
在克罗恩病的1376次治疗事件中，维多珠单抗治疗组每100人年（PY）的严重感染率为5.18（95%CI = 3.98 - 6.63），而抗TNF治疗组为3.54（95%CI = 2.50 - 4.85）；HR = 1.72（95%CI = 1.12 - 2.65），部分原因是胃肠道感染较多。与匹配的普通人群队列中0.75/100 PY（95%CI = 0.59 - 0.92）的感染率相比，维多珠单抗显示出更高的风险（HR = 7.00；95%CI = 5.04 - 9.72）。在溃疡性结肠炎的1294次治疗事件中，相应的感染率在最初1.1年时，维多珠单抗治疗组为3.74/100 PY（95%CI = 2.66 - 5.11），抗TNF治疗组为3.42/100 PY（95%CI = 2.31 - 4.89）；HR = 0.80（95%CI = 0.47 - 1.36），1.1年后HR = 2.03（95%CI = 0.65 - 6.32）（因风险不成比例而截断）。抗TNF治疗组中肺炎占所有感染的40%，而维多珠单抗治疗组未观察到肺炎病例。与匹配的普通人群队列中0.69/100 PYs（95%CI = 0.53 - 0.87）的感染率相比，维多珠单抗的HR为5.45（95%CI = 3.67 - 8.11）。
与抗TNF相比，维多珠单抗在克罗恩病中与严重感染风险增加相关，但在溃疡性结肠炎中并非如此。尽管如此，两种药物的严重感染情况似乎有所不同。我们的研究结果强调了对感染的临床认识以及这两种治疗方法安全性的重要性。
