Q:  I am a staff nurse doing home infusion. I’ve seen an increase in new home patients requiring infusions of Remicade and Entyvio this year.I have a patient to start soon and I have found no evidence on how safe these drugs are if administered at home. They are given in a doctor’s office where there is always a doctor present during the infusion in case there’s a problem or a reaction. Do you have any evidence based information you  can share?  Thank you in advance.

A:  First, let’s define the term “biologics”. By definition, these are agents derived from biological sources or agents that affect biological responses. Biologics include a diverse range of products such as bacterial and viral vaccines; tissues; human blood and plasma and their derivatives; and certain products produced by biotechnology. The two drugs you mentioned, Remicade (infliximab) and Entyvio (vedolizumab) are examples of biologics used for treatment of inflammatory disorders such as Crohn’s disease and rheumatoid diseases like rheumatoid arthritis, psoriasis, psoriatic arthritis and anklyosing spondylitis. There are other common biologics you are familiar with but are not called biologics – those are Immune Globulin (IGIV) and Enzyme Replacement Therapies for Fabry, Hunter’s disease, etc… Many use the term ‘biologics” to mean only the drugs used for autoimmune inflammatory disorders exclusively. While others refer to all these biologics as specialty medications.

We are all aware that the drugs you have mentioned have been successfully given in the home, even though majority are still given in a hospital outpatient departments, physician’s office infusion clinics, and other outpatient settings. We also know that the choice of where to get an infusion is affected by many factors, one of which is directed by commercial insurance providers. A limited body of evidence that suggest that home infusion is cost effective and well tolerated by patients are:

1. Condino AA, Fidanza S, Hoffenberg EJ.A home infliximab infusion program. J Pediatr Gastroenterol Nutr. 2005 Jan;40(1):67-9.
2. Kuin S, Stolte SB, van den Brink GR, Ponsioen CY, Fockens P, D’Haens GR, Löwenberg M.Remicade infusions at home: an alternative setting of infliximab therapy for patients with Crohn’s disease.Eur J Gastroenterol Hepatol. 2016 Feb;28(2):222-5. doi: 10.1097/MEG.0000000000000530.

Unfortunately, not much data on safe administration at home for these drugs, so it’s still quite controversial. The American College of Rheumatology (ACR) position statement on Patient Safety and Site of Service for Infusible Biologics (02/2106) states “Intravenous biologic agents should be administered in a health care setting with onsite supervision by a physician trained in biologic infusions. Home infusion policies designed for the sole purpose of cutting costs undermine patient safety.”  Click here to access the ACR position paper.

There are anecdotal reports and unpublished studies of patients successfully and safely receiving their maintenance doses at home. Such studies are not easily accessible, and perhaps are considered  weak body of evidence.

Many home infusion providers are comfortable infusing these patients at home because they have experience in home infusions of other biologics such as IGIV and ERTs. These infusion providers have highly skilled infusion nurses (like you), developed extensive clinician training /competency, patient eligibility criteria for acceptance to home infusion services and infusion protocols for potential adverse event management related to these specialty meditations.

Hope this helps and thank you for your question.