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2007-2017 年家庭与机构实施生物制剂输注的不良事件比较。

Comparison of Adverse Events Among Home- vs Facility-Administered Biologic Infusions, 2007-2017.

机构信息

Division of Immunology and Rheumatology, Department of Medicine, Stanford University, Stanford, California.

Quantitative Sciences Unit, Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Stanford, California.

出版信息

JAMA Netw Open. 2021 Jun 1;4(6):e2110268. doi: 10.1001/jamanetworkopen.2021.10268.

Abstract

IMPORTANCE

Infusion reactions occur in 7% to 20% of patients receiving biologics. Home infusions are convenient and incur lower costs but may be associated with more adverse events; the safety of receiving biologic infusions for immune-mediated diseases at home remains unclear.

OBJECTIVE

To assess whether patients receiving home biologic infusions have increased adverse events requiring emergency department (ED) or hospital admission compared with patients receiving facility infusions.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used administrative claims data from a large national insurer for adult patients who received biologic infusions for immune-mediated disease between January 2007 and December 2017. Patients with hematologic malignant neoplasms or bone marrow transplantation were excluded. Data were analyzed from August 2019 to October 2020.

MAIN OUTCOMES AND MEASURES

ED or hospital admission on the same or next day after administration of a biologic infusion at home vs at a facility; secondary outcomes included discontinuation of the biologic after an ED or hospital admission and postinfusion mortality.

RESULTS

Of a total of 57 220 patients (mean [SD] age, 50.1 [14.8] years; 512 314 [68.1%] women) who received 752 150 biologic infusions (34 078 home infusions [4.5%] to 3954 patients and 718 072 facility infusions [95.5%] to 54 770 patients), patients who received home infusions were younger (mean [SD] age, 43.2 [13.2] vs 51.3 [14.8] years), more likely to be men (14 031 [41.2%] vs 225 668 [31.4%]), and had a lower Charlson comorbidity score compared with patients who received facility infusions (mean [SD] score, 0.5 [1.0] vs 1.1 [1.3]). Home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after the infusion (odds ratio [OR], 1.25; 95% CI, 1.09-1.44; P = .002) and 28% increased odds of discontinuation of the biologic after the ED or hospital admission (OR, 1.28; 95% CI, 1.08-1.51; P = .005). There was no difference in postinfusion mortality between home or facility infusions. The rates of adverse events were highest with home infusions of tocilizumab (48 of 481 infusions [10.0%]), vedolizumab (150 of 2681 infusions [5.6%]), and infliximab (1085 of 20 653 infusions [5.3%]), although the number of tocilizumab and vedolizumab infusions was low.

CONCLUSIONS AND RELEVANCE

In this study, biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care. Because the number of home infusions has increased and is expected to continue to rise, the safety implications of administering biologic infusions at home needs to be further assessed.

摘要

重要性

接受生物制剂治疗的患者中有 7%至 20%会发生输注反应。家庭输注方便且费用较低,但可能与更多不良事件相关;在家中接受免疫介导性疾病的生物输注的安全性仍不清楚。

目的

评估在家中接受生物输注的患者与在医疗机构接受输注的患者相比,是否有更多需要急诊(ED)或住院治疗的不良事件。

设计、地点和参与者:这是一项回顾性队列研究,使用了来自一家大型全国保险公司的行政索赔数据,纳入了 2007 年 1 月至 2017 年 12 月期间接受免疫介导性疾病生物输注的成年患者。排除血液恶性肿瘤或骨髓移植患者。数据分析于 2019 年 8 月至 2020 年 10 月进行。

主要结局和测量指标

在家中或医疗机构输注后同日或次日发生 ED 或住院治疗;次要结局包括 ED 或住院治疗后停止使用生物制剂以及输注后死亡率。

结果

在共 57220 名(平均[SD]年龄,50.1[14.8]岁;512314 名[68.1%]女性)接受 752150 次生物输注(34078 次家庭输注[4.5%]至 3954 名患者和 718072 次设施输注[95.5%]至 54770 名患者)的患者中,接受家庭输注的患者年龄更小(平均[SD]年龄,43.2[13.2]岁 vs 51.3[14.8]岁),更可能是男性(14031 名[41.2%] vs 225668 名[31.4%]),且Charlson 合并症评分低于在医疗机构接受输注的患者(平均[SD]评分,0.5[1.0] vs 1.1[1.3])。与在医疗机构接受输注的患者相比,家庭输注后同日或次日发生 ED 或住院治疗的可能性增加了 25%(比值比[OR],1.25;95%CI,1.09-1.44;P = 0.002),且 ED 或住院治疗后停止使用生物制剂的可能性增加了 28%(OR,1.28;95%CI,1.08-1.51;P = 0.005)。家庭或医疗机构输注后无差异的死亡率。托珠单抗(48/481 次输注[10.0%])、vedolizumab(150/2681 次输注[5.6%])和 infliximab(1085/20653 次输注[5.3%])的家庭输注不良事件发生率最高,尽管托珠单抗和 vedolizumab 的输注次数较少。

结论和相关性

在这项研究中,与在医疗机构接受输注相比,在家中接受生物制剂输注与需要升级治疗的不良事件增加相关。由于家庭输注的数量增加且预计将继续增加,在家中给予生物制剂输注的安全性需要进一步评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bab8/8176330/c5c4b3051260/jamanetwopen-e2110268-g001.jpg

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