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生物疗法在炎症性肠病的西班牙裔与非西班牙裔患者中的疗效和安全性:CA-IBD 队列研究。

Effectiveness and Safety of Biologic Therapy in Hispanic Vs Non-Hispanic Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study.

机构信息

Division of Gastroenterology, Department of Medicine, UC San Diego, La Jolla, California; Division of Biomedical Informatics, Department of Medicine, UC San Diego, La Jolla, California.

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

出版信息

Clin Gastroenterol Hepatol. 2023 Jan;21(1):173-181.e5. doi: 10.1016/j.cgh.2022.05.008. Epub 2022 May 27.

Abstract

BACKGROUND & AIMS: There are limited data on outcomes of biologic therapy in Hispanic patients with inflammatory bowel diseases (IBDs). We compared risk of hospitalization, surgery, and serious infections in Hispanic vs non-Hispanic patients with IBD in a multicenter, electronic health record-based cohort of biologic-treated patients.

METHODS

We identified adult patients with IBD who were new users of biologic agents (tumor necrosis factor α [TNF-α] antagonists, ustekinumab, vedolizumab) from 5 academic institutions in California between 2010 and 2017. We compared the risk of all-cause hospitalization, IBD-related surgery, and serious infections in Hispanic vs non-Hispanic patients using 1:4 propensity score matching and survival analysis.

RESULTS

We compared 240 Hispanic patients (53% male; 45% with ulcerative colitis; 73% TNF-α antagonist-treated; 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male; 44% with ulcerative colitis; 67% TNF-α antagonist-treated; 27% with prior biologic exposure). After propensity score matching, Hispanic patients were younger (37 ± 15 vs 40 ± 16 y; P = .02) and had a higher burden of comorbidities (Elixhauser index, >0; 37% vs 26%; P < .01), without any differences in patterns of medication use, burden of inflammation, and hospitalizations. Within 1 year of biologic initiation, Hispanic patients had higher rates of hospitalizations (31% vs 23%; adjusted hazard ratio [aHR], 1.32; 95% CI, 1.01-1.74) and IBD-related surgery (7.1% vs 4.6%; aHR, 2.00; 95% CI, 1.07-3.72), with a trend toward higher risk of serious infections (8.8% vs 4.9%; aHR, 1.74; 95% CI, 0.99-3.05).

CONCLUSIONS

In a multicenter, propensity score-matched cohort of biologic-treated patients with IBD, Hispanic patients experienced higher rates of hospitalization, surgery, and serious infections. Future studies are needed to investigate the biological, social, and environmental drivers of these differences.

摘要

背景与目的

关于生物治疗对炎症性肠病(IBD)西班牙裔患者结局的数据有限。我们比较了在加利福尼亚州 5 所学术机构接受生物治疗的患者中,西班牙裔与非西班牙裔 IBD 患者的住院、手术和严重感染风险。

方法

我们在 2010 年至 2017 年间,确定了新使用生物制剂(肿瘤坏死因子-α [TNF-α]拮抗剂、乌司奴单抗、维得利珠单抗)的 IBD 成年患者,来自加利福尼亚州的 5 所学术机构。我们使用 1:4 倾向评分匹配和生存分析比较了西班牙裔与非西班牙裔患者的全因住院、IBD 相关手术和严重感染风险。

结果

我们比较了 240 例西班牙裔患者(53%为男性;45%为溃疡性结肠炎;73%接受 TNF-α 拮抗剂治疗;20%有过生物制剂暴露)和 960 例非西班牙裔患者(51%为男性;44%为溃疡性结肠炎;67%接受 TNF-α 拮抗剂治疗;27%有过生物制剂暴露)。经过倾向评分匹配后,西班牙裔患者更年轻(37 ± 15 岁比 40 ± 16 岁;P =.02),合并症负担更重(Elixhauser 指数>0;37%比 26%;P <.01),但用药模式、炎症负担和住院治疗无差异。在生物制剂起始后 1 年内,西班牙裔患者的住院率更高(31%比 23%;校正后的危险比[HR],1.32;95%CI,1.01-1.74)和 IBD 相关手术率更高(7.1%比 4.6%;HR,2.00;95%CI,1.07-3.72),严重感染风险也有升高趋势(8.8%比 4.9%;HR,1.74;95%CI,0.99-3.05)。

结论

在生物治疗 IBD 的多中心、倾向评分匹配队列中,西班牙裔患者的住院、手术和严重感染发生率更高。需要进一步的研究来探究这些差异的生物学、社会和环境驱动因素。

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