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生物制剂在伴有活动性或近期恶性肿瘤的炎症性肠病患者中的安全性比较:一项多中心队列研究。

Comparative Safety of Biologic Agents in Patients With Inflammatory Bowel Disease With Active or Recent Malignancy: A Multi-Center Cohort Study.

机构信息

Division of Gastroenterology, New York University Langone Health, New York, New York; Division of Gastroenterology, University of California San Diego, La Jolla, California.

Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, California.

出版信息

Clin Gastroenterol Hepatol. 2023 Jun;21(6):1598-1606.e5. doi: 10.1016/j.cgh.2023.01.002. Epub 2023 Jan 13.

Abstract

BACKGROUND & AIMS: Safety of biologic agents is a key consideration in patients with inflammatory bowel disease (IBD) and active or recent cancer. We compared the safety of tumor necrosis factor (TNF)-α antagonists vs non-TNF biologics in patients with IBD with active or recent cancer.

METHODS

We conducted a multicenter retrospective cohort study of patients with IBD and either active cancer (cohort A) or recent prior cancer (within ≤5 years; cohort B) who were treated with TNFα antagonists or non-TNF biologics after their cancer diagnosis. Primary outcomes were progression-free survival (cohort A) or recurrence-free survival (cohort B). Safety was compared using inverse probability of treatment weighting with propensity scores.

RESULTS

In cohort A, of 125 patients (483.8 person-years of follow-up evaluation) with active cancer (age, 54 ± 15 y, 75% solid-organ malignancy), 10 of 55 (incidence rate [IR] per 100 py, 4.4) and 9 of 40 (IR, 10.4) patients treated with TNFα antagonists and non-TNF biologics had cancer progression, respectively. There was no difference in the risk of progression-free survival between TNFα antagonists vs non-TNF biologics (hazard ratio, 0.76; 95% CI, 0.25-2.30). In cohort B, of 170 patients (513 person-years of follow-up evaluation) with recent prior cancer (age, 53 ± 15 y, 84% solid-organ malignancy; duration of remission, 19 ± 19 mo), 8 of 78 (IR, 3.4) and 5 of 66 (IR 3.7) patients treated with TNFα antagonists and non-TNF biologics had cancer recurrence, respectively. The risk of recurrence-free survival was similar between both groups (hazard ratio, 0.94; 95% CI, 0.24-3.77).

CONCLUSIONS

In patients with IBD with active or recent cancer, TNFα antagonists and non-TNF biologics have comparable safety. The choice of biologic should be dictated by IBD disease severity in collaboration with an oncologist.

摘要

背景与目的

生物制剂的安全性是炎症性肠病(IBD)患者和活动性或近期癌症患者的关键考虑因素。我们比较了 IBD 患者中肿瘤坏死因子(TNF)-α拮抗剂与非 TNF 生物制剂在活动性或近期癌症患者中的安全性。

方法

我们对患有 IBD 且患有活动性癌症(队列 A)或近期(≤5 年内)既往癌症(队列 B)的患者进行了一项多中心回顾性队列研究,这些患者在癌症诊断后接受了 TNFα 拮抗剂或非 TNF 生物制剂治疗。主要结局是无进展生存期(队列 A)或无复发生存期(队列 B)。使用倾向评分逆概率治疗加权法比较安全性。

结果

在队列 A 中,125 例(483.8 人年随访评估)活动性癌症患者(年龄 54±15 岁,75%为实体器官恶性肿瘤)中,55 例患者中有 10 例(每 100 人年发生率[IR],4.4)和 40 例患者中有 9 例(IR,10.4)接受 TNFα 拮抗剂和非 TNF 生物制剂治疗的患者发生癌症进展。TNFα 拮抗剂与非 TNF 生物制剂之间无进展生存期的风险无差异(风险比,0.76;95%CI,0.25-2.30)。在队列 B 中,170 例(513 人年随访评估)近期既往癌症患者(年龄 53±15 岁,84%为实体器官恶性肿瘤;缓解持续时间 19±19 个月)中,78 例患者中有 8 例(IR,3.4)和 66 例患者中有 5 例(IR,3.7)接受 TNFα 拮抗剂和非 TNF 生物制剂治疗的患者发生癌症复发。两组之间无复发生存期的风险相似(风险比,0.94;95%CI,0.24-3.77)。

结论

在活动性或近期癌症的 IBD 患者中,TNFα 拮抗剂和非 TNF 生物制剂具有相当的安全性。生物制剂的选择应根据 IBD 疾病严重程度与肿瘤学家共同决定。

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