N803 Accelerated infusions of biosimilar infliximab are safe and well tolerated and monitoring post-infusion is not required
Robinson K., Wright A., Marshall L., Lobo A.
Sheffield Teaching Hospitals NHS Trust, Gastroenterology, Sheffield, United Kingdom
Infliximab is an anti TNFα antibody widely used in the treatment of inflammatory bowel disease. Accelerated infusion durations over 30–60 minutes, with reduced post infusion monitoring of 30–60 minutes have been shown to be safe and well tolerated in the originator molecule Remicade . We previously audited 310 Remicade infusions in 103 patients and found that accelerated infusions were safe and that monitoring patients post-infusion was not necessary. Our unit started prescribing biosimilar infliximab Remsima in new starters in April 2016, and switched patients from Remicade from June 2016. The aim of this audit was to evaluate the safety of accelerated infusions of Remsima and the need for post-infusion monitoring.
276 Remsima infusions were administered to 154 patients during April to October 2016 (6 months). Data was recorded on completion of the infusion and post-infusion monitoring (PIM). Infusions were administered over 30, 60 or 120 minutes (Table 1). In patients switching from Remicade the first infusion was administered over at least 60 minutes. Patients receiving doses of 10mg/kg had their infusions administered over at least 60 minutes. In order to assess the need for PIM all patients were observed for 30 minutes following completion of the infusion. Blood pressure, pulse, respiratory rate, oxygen saturations were recorded every 30 minutes during the infusion and 30 minutes after completion of the infusion. Adverse reactions were classified as:
Mild: no action required Severe: immediate action or treatment withdrawal
Mild: no action required
Severe: immediate action or treatment withdrawal
A systolic drop in BP of ≥20mm/Hg was documented with details of action taken. Treatment of reaction and outcomes were recorded, including occurrence during infusion or post-infusion period. Details of any delayed reactions following discharge were obtained from patient notes.
During the infusion: 1 patient (0.36%) had a severe adverse reaction during the first Remsima infusion following a switch from Remicade. BP dropped ≥20mm/Hg during 19 infusions in 16 patients (range 22–50mm/Hg, median 24mm/Hg). No action was taken, all patients discharged following 30 minute post-infusion observation.
Post-infusion monitoring: No adverse reactions were recorded during the PIM.
1 patient had a drop in systolic BP of 24mg/Hg. No action was taken. There were no patient self-reported adverse events post-discharge.
1 patient had a drop in systolic BP of 24mg/Hg. No action was taken.
There were no patient self-reported adverse events post-discharge.
Observed infusion reaction rate was 0.36% (2.91% infusion reaction in previous Remicade infusion audit). No adverse reactions occurred in the post-infusion monitoring period This audit suggests that accelerated infusions of Remsima are safe and well tolerated and post-infusion monitoring is unnecessary.
Observed infusion reaction rate was 0.36% (2.91% infusion reaction in previous Remicade infusion audit).
No adverse reactions occurred in the post-infusion monitoring period
This audit suggests that accelerated infusions of Remsima are safe and well tolerated and post-infusion monitoring is unnecessary.
 Donnelan CF. et al. (2009), Accelerated infliximab infusions are safe and well tolerated in patients with inflammatory bowel disease, Eur J Gastroenterology & Hepatology, 21(1)71–75