P528 Reducing intravenous monoclonal antibody observation times without compromising patient safety; a single-centre observational study.

Background

Monoclonal antibodies (MAbs) are integral to manage Inflammatory Bowel Disease (IBD). At Brighton & Sussex University Hospitals, intravenous MAbs, infliximab and vedolizumab, are administered in an outpatient setting. Licensing specifies post-infusion observation times of 1 to 2 hours. This affects waiting lists and capacity, particularly pertinent during the COVID-19 pandemic.

Methods

A single-centre observation study was conducted.  

Part 1  

Retrospective data was collected for all infliximab and vedolizumab infusions from April to July 2019. Patients seen twice, were included once. For established infusion patients, historical reactions were recorded. Reaction incidence was established by observations, patient questioning and patient record review.  

To standardise the reactions, we used the cancer Common Terminology Criteria for Adverse Events; grade 3 is ‘severe’.  

Part 2  

Observation time was removed from infusion 4 in April 2020. Prospective data was collected for all infliximab and vedolizumab infusions from April to December 2020. Multiple attendances were included. 

Results

Part 1 

130 infliximab patients (2607 infusions) and 69 vedolizumab patients (557 infusions) were reviewed. 

No severe reactions were recorded. All reactions occurred during induction dosing period. Analysis showed high levels of ‘no reactions observed’ after the first 4 infliximab infusions 97.7% (+1.6%, -4.7%), and the first 3 vedolizumab infusions 96.9% (+2.3%, -8.8%).   

121 hours could be saved for infliximab and 64 hours for vedolizumab. Extrapolated this equates to 740 hours per year.  


Part 2  

679 infliximab infusions were administered (including 12 new starters). 418 vedolizumab infusions were administered (16 new starters). No reactions were reported. 

Table 1: Observed MAb Infusion Reactions and Management

			Pt	Inf	Reactions	Inf Occurrence	Grade	Symptoms	Management	MAb Stopped
INFLIXIMAB	Part 1	Induct	130	2607	3 (0.12%)	1	2	Itching	Chlorphenamine IV	No
						2	2	Flushing & chest tightness	Hydrocortisone IV, chlorphenamine IV + paracetamol PO	Yes
						3	2	Shortness of breath	Chlorphenamine IV	No
		Maint	121	2583	0	-	-	-	-	-
INFLIXIMAB	Part 2	-	NC	679	0	-	-	-	-	-
VEDOLIZUMAB	Part 1	Induct	69	557	1 (0.18%)	1	1	Headache	Paracetamol PO	No
		Maint	64	550	0	-	-	-	-	-
VEDOLIZUMAB	Part 2	-	NC	418	0	-	-	-	-	-

Table key: Pt – patients, Inf – infusions, MAb – monoclonal antibody, Induct – Induction, Maint – maintenance, IV – intravenous, PO – oral, NC – not collected