2-16. Switching from Remicade® to Remsima® is safe and feasible: a prospective, open-label study.

Lydia C.T. Buer¹,², Bjørn A. Moum¹,², Milada Cvancarova³, David J. Warren ⁴, Asle W. Medhus¹, Marte L. Høivik¹
¹Department of Gastroenterology, Oslo University Hospital ²Faculty of Medicine, University of Oslo ³Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences ⁴Department of Medical Biochemistry, Oslo University Hospital
lydiabuer@gmail.com

Background and aims
A biosimilar version of infliximab (CT-P13/Remsima®) recently entered the European market. The clinical data on its use in inflammatory bowel disease are sparse, especially on switching from the originator Remicade®. In this study, we aimed to prospectively investigate the feasibility, safety and immunogenicity of switching from Remicade® to Remsima® in a real-life IBD population.

Methods
All adult patients who were treated with Remicade® in the Department of Gastroenterology at Oslo University Hospital were switched to Remsima®. The follow-up lasted for 6 months. In addition, a retrospective registration was performed with a start time of 6 months before switching drugs. The primary endpoints were i) the proportion of patients remaining on medication 6 months after switching and ii) adverse events during the 6 months after switching. The secondary endpoints included i) disease activity scores (Harvey-Bradshaw Index and Partial Mayo Score), C-reactive protein, haemoglobin, faecal calprotectin, Infliximab dose and interval, p-infliximab and ii) the development of antidrug antibodies.

Results
In total, 143 IBD patients were switched, 99 with Crohn’s disease and 44 with ulcerative colitis. The large majority (97%) remained on the medication throughout follow-up. A low number of adverse events were observed. No change in disease activity, C-reactive protein, haemoglobin, faecal calprotectin, Infliximab dose and interval or p-Infliximab was detected. Three patients developed new detectable antidrug antibodies.

Conclusions
Our study demonstrated that switching from Remicade® to Remsima® was feasible and with few adverse events, including very limited antidrug antibody formation and loss of response.

(Submitted in JCC 09.09.2016)