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N805 Do we need to monitor patients after vedolizumab infusion?

Robinson K., Marshall L., Wright A., Lobo A.

Sheffield Teaching Hospitals NHS Trust, Gastroenterology, Sheffield, United Kingdom

Background

Vedolizumab is a humanised IgG monoclonal antibody that is licensed for use in moderate to severe ulcerative colitis and Crohn's disease. The manufacturer advises that vedolizumab is administered over thirty minutes, and that patients are observed for 2 hours after the first 2 infusions and for 1 hour after subsequent infusions for signs and symptoms of acute infusion related reactions.

The aim of this audit was to establish whether monitoring following completion of the infusion is required.

Methods

179 Vedolizumab infusions were administered to 55 patients from November 2015 to July 2016 (9 months). Data was recorded on completion of the infusion and post infusion monitoring (PIM) period. Infusions were administered over 30 minutes. Patients were observed post infusion for 120 minutes following the first 2 doses, and 60 minutes after subsequent doses. Blood pressure, pulse, respiratory rate, oxygen saturations were recorded at the start and on completion of the infusion and hourly during post infusion monitoring. A systolic drop in BP of ≥20mm/Hg and details of action taken were documented. Adverse reactions, their treatment and outcomes were recorded, including occurrence during infusion or post infusion period. Adverse reactions were classified as:

mild: no action required

moderate: action required but treatment continued

Severe: immediate action or treatment withdrawal.

Results

During the infusion: 1 patient had an adverse reaction during each of 3 infusions (1 moderate, 2 mild).

Systolic BP dropped ≥20mm/Hg in 3 patients (25–30mm/Hg). All patients were asymptomatic and infusions were completed as plan.

During PIM:

1 patient did not comply with the PIM regime after their first infusion with no self-reported adverse events.

1 patient had a drop in systolic BP of 21mg/Hg following infusion 4 requiring no action.

No adverse reactions were recorded in 55 patients following 178 infusions.

1 patient reported joint aches post discharge which settled spontaneously.

Conclusion

Observed infusion reaction rate was 1.67%

No adverse reactions occurred during post infusion monitoring.

BP drops >20mm/Hg were observed in 1.67% infusions and 0.56% during post infusion monitoring. All patients were asymptomatic and no action was taken.

We suggest post-vedolizumab infusion monitoring is unnecessary.

In this Teaching Hospital setting, 347 hours of patient and nurse time could be saved per annum based on current infusion numbers.