Tolerability of Shortened Infliximab Infusion in Scheduled Maintenance Therapy for IBD: a Prospective Multi-center European Cohort Study

Abstract

AIM: Although an infusion time of at least one hour is mandated by the European label for infliximab (IFX) maintenance treatment of patients with IBD, shorter infusion times of 30 minutes have been reported with low dose treatment in rheumatoid arthritis. The aim of this study was to prospectively evaluate the tolerability of shortened IFX infusions in a multi-center cohort study. METHODS: Adults with Crohn’s disease or ulcerative colitis tolerating at least seven IFX infusions (5 mg/kg) of which at least 3 infusions over one hour, without infusion reactions, were invited to receive the same dose in 30 minutes for four consecutive infusions and with the same dosing frequency. The primary endpoint was the proportion of patients completing the trial without a severe infusion reaction. Tolerability, infusion times and total procedure times, clinical disease activity and patient preference was assessed at every infusion. RESULTS: One hundred eleven (25 UC, 84 CD, 2 IBD-unclassified) patients enrolled in the trial. All shortened, 30 minute infusions were completed by 91/111 (83%) patients and no severe infusion reactions were observed. Mild to moderate reactions occurred in 10/111 patients (6 acute) and twenty terminated before week 24; infusion reactions (11), increased dosing of IFX (4), loss of efficacy (4) and 1 patient moved out of the country. Median clinical activity indices and CRP remained stable throughout the study. CONCLUSION: In a selected population of patients with IBD, who have tolerated IFX maintenance infusions, infusion times can be shortened from one hour to 30 minutes. No severe infusion reactions were observed.