P588 Switching from infliximab originator to a first biosimilar is safe and effective: A single-centre series with through levels and anti-drug antibodies determination

Abstract

Background: Treatment of inflammatory bowel disease (IBD) with anti-TNF drugs is hampered by notable costs. Over the past 2 years, CPT-13, a biosimilar infliximab, was released, on the market with substantial cost savings. Still the switch from originator to biosimilar is not systematically used due to fear of potential side effects. Aim of this study was to perspectively evaluate the effectiveness and safety of switch comparing to treatment outcomes in a consecutive series of patients treated only with biosimilar infliximab Methods: Cases were IBD patients undergoing originator infliximab, who were switched to CPT-13 since April 2016 (switch cases). Controls were patients who were started as first biologic on CPT-13, after its commercialisation in Italy (naive cases). Patients were enrolled in a longitudinal cohort study approved by Local Ethical Committee. At basal and following time points also samples for through levels (TL) and antibodies to infliximab (ATI) determination were drawn. Persistence in the treatment, adverse outcomes, infusion reaction and variations in TL and ATI were recorded and compared among the two groups. Results: Sixty-nine consecutive IBD patients (33 Crohn's disease-, CD, and 36 ulcerative colitis, UC) were enrolled. Switch cases were 54 (group A) and naive cases were 15 (group B). No significant differences in basal characteristics were noted between the two groups, excluding a longer infliximab treatment among switch cases (p < 0.0001). At entry significantly more patients in group A were in remission/mild activity compared with group B (p < 0.01). Clinical adverse events were significantly less in group A (p < 0.05). Preliminary analysis of TL and ATI did not reveal significant variations comparing the two groups. Figure 1 is plotted evolution of TL between basal and subsequent time points. https://planner.smart-abstract.com/ecco2018/submission/en/abstract/6951/content# Conclusions: In this real-life experience of systematic switch between infliximab originator and biosimilar, without patient selection based on clinical characteristics, switch was not associated to adverse outcomes, on contrary, probably due to longer treatment duration, less adverse outcomes were recorded among patients who switched to biosimilar. TL and ATI analysis is still ongoing.