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09-06-2021 | Biologics | News

Home-based biologic infusions may increase risk for AEs requiring care escalation

Author:
Laura Cowen

medwireNews: Home-administered biologic infusions are associated with higher risks for postinfusion emergency department (ED) visits or hospital admission and treatment discontinuation compared with facility-administered infusions, real-world data show.

Writing in JAMA Network Open, Matthew Baker and colleagues, from Stanford University in California, USA, say their “findings suggest that the safety implications of administering biologic infusions at home need to be assessed further.”

The study included administrative claims data for 57,220 patients (mean age 50 years, 68.1% women) with immune-mediated diseases – most commonly rheumatic (58.0%) or gastroenterological (25.4%) conditions – who received 752,150 biologic infusions between January 2007 and December 2017.

Of these, 4.5% of infusions were administered at home and 95.5% were administered at a healthcare facility. The researchers note that the proportion receiving home-administered infusions increased from 3.8% in 2015 to 7.2% in 2017.

The most common home-administered biologics were infliximab (60.6%), natalizumab (19.6%), and vedolizumab (7.9%), while the most common facility administered drugs were infliximab (52.1%), abatacept (15.4%), and natalizumab (13.3%).

Baker and team report that 4.4% of the 34,078 home-administered infusions were followed by an ED visit or hospital admission on the same or next day. By comparison, the rate was 3.5% for facility-administered infusions.

After adjusting for potential confounders such as age, sex, comorbidity, disease type, infusion agent, and recent glucocorticoid use, the investigators found that home-administered infusions were associated with a significant 25% increased risk for ED or hospital admission on the same or next day relative to facility-based infusions.

In addition, home-based infusions were associated with a 28% increased likelihood for permanent biologic discontinuation after an ED or hospital admission versus facility-based infusions, with rates of 0.6% and 0.4%, respectively.

Conversely, there was no significant difference between the two groups in post-infusion mortality rates.

Baker and team also observed that patients receiving home infusions were younger and had fewer comorbidities than those treated at a facility, yet they were still at increased risk for adverse events, which they say “raises concerns about the possibility of increased usage of home infusions in older patients with more comorbidities and more severe immune-mediated disease.”

In an accompanying comment, Gregory Calip (Flatiron Health Inc, New York, USA) and colleagues say: “With the expansion of home health care coverage and greater utilization of home-based infusion services for patients amid the COVID-19 pandemic, the evidence provided here is highly relevant to understanding the risks and benefits of these disease-altering biologic therapies in different treatment settings.”

They stress that “[o]nly a randomized clinical trial could establish a causal association between home infusion of biologic agents and subsequent adverse events and discontinuation of the agent,” but note that “conducting such a trial at this scale would be costly and may not reflect the uncontrolled conditions that occur in clinical practice.”

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

9 June 2021: The coronavirus pandemic is affecting all healthcare professionals across the globe. Medicine Matters’ focus, in this difficult time, is the dissemination of the latest data to support you in your research and clinical practice, based on the scientific literature. We will update the information we provide on the site, as the data are published. However, please refer to your own professional and governmental guidelines for the latest guidance in your own country.

JAMA Netw Open 2021; 4: e2110268
JAMA Netw Open 2021; 4: e2111156

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