Home biologic infusions linked to 25% increased odds of hospital admission
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Biologic infusions administered at home are associated with a 25% increased risk for hospital admission the same or next day, and a 28% higher risk for permanent discontinuation, compared with facility-given infusions, according to data.
“Biologic infusions are highly effective treatments for many patients with autoimmune and immune-mediated diseases, but they have the potential to cause serious adverse events,” Matthew C. Baker, MD, MS, of Stanford University, told Healio Rheumatology. “In an infusion center or office setting, biologic infusions are overseen by trained physicians with experience and resources for managing side effects and complications. This is typically not the case when biologic infusions are administered at home.”
“Our data show a recent increase in the proportion of biologic infusions administered at home. Although some of the increase in home infusions may be due to patient preference, we believe this increase is driven in large part by the payors, who now frequently require patients to receive infusions in the lower cost home environment.”
To examine whether home infusions are associated with increased adverse events that require hospital or ED admission, compared with infusions given in a facility, Baker and colleagues conducted a retrospective cohort study of administrative claims data found in the Optum Clinformatics Data Mart. Focusing on the period from Jan. 1, 2007, to Dec. 31, 2017, the researchers included adults with at least one ICD-10 code for an immune-mediated disease, as well as at least one J-code for a biologic infusion.
Infusions given to patients with a history of hematologic malignant neoplasms or bone marrow transplantation, as well as patients who did not have place of service documented in the database, were excluded. In all, the researchers included 57,220 patients who received a total of 752,150 biologic infusions in their analysis. Among these, there were 34,078 home infusions across 3,954 patients, and 718,072 facility infusions administered to 54,770 patients.
The primary outcome was ED or hospital admission on the same or next day following infusion at home, compared with at a facility. Secondary outcomes included biologic discontinuation following hospital or ED admission and post-infusion mortality.
According to the researchers, who published their findings in JAMA Network Open, patients who received home infusions were younger — with a mean age of 43.2 years (standard deviation = 13.2), versus 51.3 years (SD = 14.8) among those with facility-given infusions — were more likely to be men and demonstrated a lower Charlson comorbidity score compared with patients who received facility infusions.
Home infusions were associated with a 25% increased likelihood of ED or hospital admission on the same or next day following the infusion (OR = 1.25; 95% CI, 1.09-1.44), and a 28% increased chance of biologic discontinuation after said admission (OR = 1.28; 95% CI, 1.08-1.51). There was no difference in post-infusion mortality between the two groups.
Adverse event rates were highest among home infusions of tocilizumab (Actemra, Genentech), at 10%; vedolizumab (Entyvio, Takeda), at 5.6%; and infliximab (Remicade, Janssen), at 5.3%. However, the number of tocilizumab and vedolizumab infusions was low, with totals of 481 and 2,681, respectively.
“The take-home message for clinicians is to carefully consider the place of infusion for biologics, especially for the first infusion, when the risk of adverse events may be the highest,” Baker said. “There are subsets of patients that are at a higher risk for adverse events and who would be better served by receiving their infusions at a facility with physician oversight. Most clinicians formulate their own opinions about where a patient should receive their infusion depending on the medical and social history for a particular patient, but at the end of the day, it is often out of their hands due to mandates from the payors.”
“We think that when issues arise in the home setting, there is a lower threshold for escalation of care,” he added. “Thus, it is not surprising that we found an increased risk of emergency department visit or hospital admission within 24 hours of home infusions compared to facility infusions. This highlights the need for more research in this area so that we can better understand which infusion setting is most appropriate for any individual patient.”
Perspective
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Gary R. Feldman, MD, FACR
The longstanding concerns of rheumatologists regarding the safety of home infusions of biologics, compared to those performed in provider-supervised facilities are supported by the findings of a recent study from Baker and colleagues, which found that home infusions increased the risk of the primary outcome of emergency department or hospital admissions by 25% with a P value of .002.
The secondary outcome of discontinuation of biologic therapy following these admissions was increased by 28% with a P value of .005. The authors indicated that this was the first study to analyze a large heterogeneous cohort of 57,220 patients receiving 752,150 infusions for a spectrum of immune-mediated diseases not confined to rheumatological conditions.
The conclusion of the study was that home infusions increased adverse events requiring escalations of care as compared to facility infusions. The data additionally revealed a trend of growth in home infusions from 3.8% to 7.2% between 2015 and 2017. Despite the findings of worse outcomes with home infusion, this group was also found to be both younger and with fewer comorbidities. Due to rising pressure to increase home infusions under the rubric of cost savings, one concern is that older and sicker patients, in the future, will be channeled into receiving home infusions.
We now have a position statement from the ACR opposing required home infusions and published data that demonstrate that home infusions are not as safe, lead to escalations of care and are more likely to cause patients to stop biologic therapies after an adverse event. Rheumatologists and other providers who prescribe biologics can use these new findings and policies to prioritize and advocate for patient safety and optimal care over claims of cost savings in the administration of infusible biologic agents for immune-mediated disease.
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