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:
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.