Background: A Biosimilar therapy CT-P13 (Celltrion, Korea; Pinewood Healthcare Ireland) was licenced in Ireland in 2013 for treatment of IBD patients. A Physician-led protocol was adopted in our Institution to switch all IBD patients receiving Infliximab (Remicade) Starting Jan 2015. The Nor-Switch study (UEG 2016) data has confirmed the safety profile and clinical effectiveness of biosimilar infliximab (Remsima). We present our 12-month Outcome Data, the first from Ireland, from a single Institution in a Private Practice Insurance reimbursed setting
Methods: All IBD patients attending our Infusion centre for Remicade were approached over a two-month period for approval to switch to the biosimilar infliximab (Remsima). All patients were subsequently switched to biosimilar infliximab (Remsima) at their next clinic visit. Data was collected over the next 12 months for the primary end-point loss of response to therapy. Data was also collected on development of antibodies and adverse reactions and surgical events.
Results: Prior to switch date 52 IBD patients received Infliximab (median duration of therapy 23 months, range (2–76 months). 74% patients maintained a long-term response to Infliximab.
33 IBD patients were therefore switched to biosimilar infliximab (Remsima) (15 CDS) - 85% remain on Biosimilar at 1 yr. 2 patients were switched during induction phase (both UC); 1 remains on biosimilar infliximab (Remsima) and 1 switched to Humira due to Antibody development. 11 patients were switched within 12 months of commencement of Infliximab therapy (10 UC); 73% (8 patients) remain on biosimilar infliximab (Remsima) at 1 year; 3 stopped due to development of antibodies (switched therapy – 1 Humira; 1 Entyvio; 1 discontinued therapy). 22 Patients were switched following more than 12 months of therapy with Remicade; 91% (20 patients) remain on therapy at 12 months; 2 stopped and subsequently switched to Humira (1 adverse side effect, 1 Antibody positive).
Conclusions: We have confirmed the recently published Nor-switch study outcomes in our small cohort of patients. Our Data confirms the safety and clinical effectiveness of the Biosimilar Remsima in an Irish setting compared to Remicade. In addition, we have confirmed the effectiveness of the Biosimilar Remsima in maintaining remission in a cohort patients previously treated with Remicade.
 Jørgensen K et al. (2016), LB15 – Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: results from the 52-week randomized NOR-SWITCH trial. Abstract presented at the United European Gastroenterology (UEG) Week meeting 2016, 15–19 October, Vienna, Austria.