Comorbidity Influences the Comparative Safety of Biologic Therapy in Older Adults With Inflammatory Bowel Diseases.
Comorbidity Influences the Comparative Safety of Biologic Therapy in Older Adults With Inflammatory Bowel Diseases.
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DOI：
10.14309/ajg.0000000000001907
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发表时间：
2022-11-01
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关于患有炎症性肠病（IBD）的老年人感染各种生物制剂的相对风险的数据有限。我们的目的是评估生物制剂在具有不同合并症负担的老年 IBD 患者中的相对安全性。我们使用来自美国大型全国性商业保险计划的数据来识别年龄≥60岁且新开始使用肿瘤坏死因子-α拮抗剂（抗TNF）、维多珠单抗或优特克单抗的 IBD 患者。使用查尔森合并症指数（CCI）定义合并症。我们的主要结局是与感染相关的住院治疗。 Cox比例风险模型适合倾向评分加权队列，以比较不同治疗类别之间的感染风险。抗 TNF、维多珠单抗和优特克单抗队列分别包括 2369 名、972 名和 352 名患者，平均年龄为 67 岁。对于开始使用维多珠单抗（HR 0.94，95% CI 0.84–1.04）和优特克单抗（0.92.,95% CI 0.74–1.16）的患者，感染相关住院率的总体比率与抗 TNF 药物相似。在 CCI >1 的患者中，与抗 TNF 药物相比，乌特克单抗（HR：0.66，95% CI：0.46-0.91，p 交互作用 <0.01）和维多珠单抗（HR：0.78，95% CI：0.65-0.94，p 交互作用：0.02）与感染相关住院率显着降低相关。 CCI ≤1 的患者之间没有发现差异。在开始生物治疗的 60 岁以上 IBD 成人中，对于合并症负担较高的患者，维多珠单抗和乌特克单抗与感染相关住院率均低于抗 TNF 治疗。
There is limited data on comparative risk of infections with various biologic agents in older adults with inflammatory bowel diseases (IBD). We aimed to assess the comparative safety of biologic agents in older IBD patients with varying comorbidity burden. We used data from a large, national commercial insurance plan in the United States to identify patients ≥60 years with IBD who newly initiated tumor necrosis factor-α antagonists (anti-TNF), vedolizumab, or ustekinumab. Comorbidity was defined using the Charlson Comorbidity Index (CCI). Our primary outcome was infection-related hospitalizations. Cox proportional hazards models were fitted in propensity-score weighted cohorts to compare the risk of infections between the different therapeutic classes. The anti-TNF, vedolizumab and ustekinumab cohorts included 2369, 972, and 352 patients, respectively, with a mean age of 67 years. The overall rate of infection-related hospitalizations was similar to that of anti-TNF agents for patients initiating vedolizumab (HR 0.94, 95% CI 0.84–1.04) and ustekinumab (0.92.,95% CI 0.74–1.16). Among patients with a CCI >1, both ustekinumab (HR: 0.66, 95% CI: 0.46–0.91, p-interaction <0.01) and vedolizumab (HR: 0.78, 95% CI: 0.65–0.94, p-interaction: 0.02) were associated with a significantly lower rate of infection-related hospitalizations compared to anti-TNFs. No difference was found among patients with a CCI ≤1. Among adults ≥60 years with IBD initiating biologic therapy, both vedolizumab and ustekinumab were associated with lower rates of infection-related hospitalizations than anti-TNF therapy for those with high comorbidity burden.