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)

Hello world!

Welcome to WordPress. This is your first post. Edit or delete it, then start writing!