炎症性肠病儿童快速 infliximab 生物类似药输注。

Rapid Infliximab Biosimilar Infusion in Children With Inflammatory Bowel Disease.

机构信息

Division of Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, University of Wisconsin School of Medicine and Public Health.

Pharmacy Department, University of Wisconsin Hospitals and Clinics.

出版信息

J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):605-609. doi: 10.1097/MPG.0000000000003402.

DOI:10.1097/MPG.0000000000003402

PMID:35149648

Abstract

OBJECTIVES

Compare prevalence of infusion reaction (IR) between infliximab (IFX) and infliximab biosimilar (IFX-abda) at standard and rapid rates and measure the impact on health care cost in children with inflammatory bowel disease (IBD).

METHODS

Records of subjects receiving IFX and IFX-abda were reviewed over a 21-month period. Demographics and IRs were recorded. Cost analysis utilized average wholesale pricing, infusion duration, nursing time, and infusion center throughput.

RESULTS

Fifty-six subjects received 498 infusions. Sixteen subjects received both IFX and IFX-abda. Thirteen IRs occurred for an overall prevalence of 2.6%. One outlier subject accounted for 8 of 13 (62%) of IRs. Data were analyzed with and without the outlier. Standard rate infusion of both IFX and IFX-abda was associated with increased risk of IR compared with rapid rate but only reached significance for IFX when calculated with the outlier removed. Risk of IR was not statistically significant between IFX and IFX-abda for both standard and rapid rates. IFX-abda saved an average of $2,611 per infusion. Rapid infusion saved 70 minutes of infusion time, 20 minutes of estimated nursing time per infusion, and decreased infusion center appointment length by as much as 2 hours per infusion.

CONCLUSIONS

Rapid IFX-abda appears safe without increased IRs and decreases cost.

摘要

目的

比较英夫利昔单抗（IFX）和英夫利昔单抗生物类似药（IFX-abda）以标准和快速输注率时输注反应（IR）的发生率，并衡量其对儿童炎症性肠病（IBD）患者医疗成本的影响。

方法

在 21 个月的时间内，回顾接受 IFX 和 IFX-abda 的患者的记录。记录人口统计学和 IR 数据。成本分析利用平均批发价格、输注时间、护理时间和输注中心吞吐量。

结果

56 名患者接受了 498 次输注。16 名患者同时接受了 IFX 和 IFX-abda。发生了 13 次 IR，总体发生率为 2.6%。1 名离群值患者占 13 次 IR 的 8 次（62%）。在有无离群值的情况下分析数据。与快速输注相比，标准输注 IFX 和 IFX-abda 的 IR 风险增加，但仅在剔除离群值后，IFX 的计算结果才有统计学意义。标准和快速输注率下，IFX 和 IFX-abda 的 IR 风险无统计学意义。IFX-abda 每次输注平均节省 2611 美元。快速输注可节省 70 分钟的输注时间，每次输注估计节省 20 分钟的护理时间，并将输注中心预约时间缩短长达 2 小时。