Comparison of Adverse Events Among Home- vs Facility-Administered Biologic Infusions, 2007-2017.
Comparison of Adverse Events Among Home- vs Facility-Administered Biologic Infusions, 2007-2017.
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DOI：
10.1001/jamanetworkopen.2021.10268
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发表时间：
2021-06-01
影响因子：
13.8
通讯作者：
Rohatgi N
中科院分区：
文献类型：
--
作者：
Baker MC;Weng Y;Fairchild R;Ahuja N;Rohatgi N
与在医疗机构接受生物输注的患者相比，在家接受生物输注的患者是否有更多需要升级护理的不良事件？在这项队列研究中，57,220例接受了72,150次生物制剂输注的免疫介导性疾病患者中，与设施输注相比，家庭输注与输注当日或次日急诊科或住院的几率增加25%相关，与急诊科或住院后永久停用生物制剂的几率增加28%相关。这些发现表明，需要进一步评估在家中进行生物输液的安全性影响。这项针对接受免疫介导性疾病生物输注的患者的队列研究，探讨了在家接受生物输注与第二天住院或急诊的关系。接受生物制剂的患者中有7% - 20%发生输液反应。家庭输液方便，费用较低，但可能与更多不良事件有关；在家中接受生物输注治疗免疫介导性疾病的安全性尚不清楚。评估与接受机构输液的患者相比，接受家庭生物输液的患者是否增加了需要急诊科（ED）或住院的不良事件。这项回顾性队列研究使用了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的大型国家保险公司的行政索赔数据。排除血液恶性肿瘤或骨髓移植患者。数据分析时间为2019年8月至2020年10月。在家中与在医疗机构进行生物输注的同一天或第二天出现急诊科或住院；次要结局包括急症或住院后停用生物制剂和输注后死亡率。共57,220例患者(平均[SD]年龄50.1[14.8]岁；接受752 150次生物输液（34 078次家庭输液[4.5%]至3954例患者，718 072次设施输液[95.5%]至54 770例患者），接受家庭输液的患者更年轻（平均[SD]年龄，43.2[13.2]对51.3[14.8]岁），更可能是男性（14 031[41.2%]对225 668[31.4%]），与接受设施输液的患者相比，Charlson共病评分更低（平均[SD]评分，0.5[1.0]对1.1[1.3]）。家庭输液与当日或次日发生ED或住院的几率增加25%相关(优势比[or]， 1.25; 95% CI, 1.09-1.44; P =。002)，急症或住院后停用生物制剂的几率增加28% （or, 1.28; 95% CI, 1.08-1.51; P = 0.005）。在家庭输液和设施输液之间，输液后死亡率没有差异。尽管托珠单抗和维多单抗的输注次数较低，但不良事件发生率最高的是托珠单抗（481次输注中有48次[10.0%]）、维多单抗（2681次输注中有150次[5.6%]）和英夫利昔单抗（20653次输注中有1085次[5.3%]）。在这项研究中，与在医疗机构进行的生物输液相比，在家中进行的生物输液与需要升级护理的不良事件增加有关。由于家庭输液的数量已经增加，并且预计将继续增加，因此需要进一步评估在家中进行生物输液的安全影响。
Do patients who receive biologic infusions at home have more adverse events requiring escalation of care compared with patients who receive biologic infusions at a facility? In this cohort study of 57 220 patients with immune-mediated disease who received 752 150 biologic infusions, home infusions were associated with 25% increased odds of emergency department or hospital admission on the same or next day after infusion compared with facility infusions and 28% increased odds of permanent discontinuation of the biologic after emergency department or hospital admission. These findings suggest that the safety implications of administering biologic infusions at home need to be assessed further. This cohort study of patients who received biologic infusions for immune-mediated diseases examines the association of infusions received at home with admission to the hospital or emergency department within the next day. 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. 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. 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. 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. 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. 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.
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影响因子：
3
作者：
Segal JB;Chang H-Y;Du Y;Walston JD;Carlson MC;Varadhan R
通讯作者：
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作者：
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通讯作者：
Sandrock, AW