P409 Non-medical reverse switch between the originator infliximab and its biosimilar in patients with inflammatory bowel disease: clinical outcomes and therapeutic drug monitoring
L. Gonczi*1, A. Ilias1, K. Szanto2, Z. Kurti1, P. A. Golovics3, K. Farkas2, E. Schafer3, Z. Szepes2, B. Szalay4, A. Vincze5, T. Szamosi3, T. Molnar2, P. Lakatos6
1Semmelweis University, First Department of Internal Medicine, Budapest, Hungary, 2University of Szeged, First Department of Medicine, Szeged, Hungary, 3Military Hospital – State Health Centre, Department of Gastroenterology, Budapest, Hungary, 4Semmelweis University, Department of Laboratory Medicine, Budapest, Hungary, 5University of Pecs, First Department of Medicine, Pecs, Hungary, 6McGill University Health Center, Division of Gastroenterology, Montreal, Canada
Switching from the originator to a biosimilar infliximab (IFX) in patients with inflammatory bowel disease (IBD) has proven to be successful, although clinical evidence is lacking on reverse and/or multiple switching. The aim of the present study was to evaluate medium-term drug sustainability, safety and immunogenicity profile of reverse switching from a biosimilar to the originator IFX in a consecutive multi-centre real-life cohort.
We performed a prospective observational study of 174 consecutive patients with IBD (136 with Crohn’s disease [CD] and 38 with ulcerative colitis [UC]) who were switched from the biosimilar infliximab CT-P13 to the originator Remicade during maintenance therapy. Previous exposure to the originator was 8% (
Complicated disease behaviour and perianal manifestation was present in 39.7% and 48.5% of CD patients. 54.1% of UC patients had extensive colitis. Previous exposure to the originator was 8.0% (
This is the first real-life cohort on mandatory reversed switch from biosimilar to originator IFX in IBD patients. No significant changes were observed in trough levels or ADA status after the reversed switch in parallel with good medium-term drug sustainability. No new safety signals were detected.