P745 Switching between anti-TNF originator and biosimilar in patients with inflammatory bowel disease: Can it be recommended? A systematic review

Abstract

Background: It is not known in detail whether it is possible to switch from infliximab reference medicinal product (RemicadeR) to biosimilar (CT-P13) in patients with inflammatory bowel disease (IBD) without any detrimental effects on safety and efficacy. Our aim was to review the effectiveness and safety of switching from a reference medicinal product to a biosimilar, focusing on the experience of switching between RemicadeR and CT-P13 in patients with IBD. Methods: Electronic and manual search in PubMed and international conferences (ECCO, UEGW, and DDW) up to September 2017. Results: We identified 24 studies evaluating the switching between RemicadeR and CT-P13 in 1326 IBD patients. Most studies were retrospective and generally included a low number of patients; only one was randomised. Effectiveness was evaluated only by clinical assessment, but not endoscopically. Follow-up ranged from 1.5 to 12 months, being 6-12 months in most studies. Disease control (no disease worsening after switching) was confirmed in most of patients (weighted mean, 88%; 95% CI = 86-89%). When only studies including a more homogeneous follow-up from 4 to 8 months were included, this figure was 90% (89-92%). When a subanalysis was conducted only for Crohn's disease, the proportion of patients maintaining disease control after switching was 86% (82-89%); the corresponding figure for ulcerative colitis was 93% (89-96%). No unexpected adverse events were reported in any of the studies. When evaluated, no differences in adverse events before and after switching were reported either. Furthermore, no differences in adverse events between patients with and without switching were confirmed (in those studies including these two subpopulations). Finally, in the only randomised controlled trial study performed up to now (the NOR-SWITCH trial), the frequencies of reported adverse events were not different between patients with and without switching. Conclusions: The risks of switching from RemicadeR to biosimilar CT-P13 seem theoretical and are not supported by the limited realworld safety experience so far. On the contrary, an increasing number of publications have shown that there seems to be no safety or efficacy concerns about switching. Therefore, switching from infliximab originator to biosimilar in patients with IBD may be considered acceptable.