P1082 Is mutiple switching between infliximab biosimilars safe in iInflammatory Bowel Disease?
Authors: Karataş A , Kirman D , Demir B , Karakan T 
Published: January 2025

Abstract

Background
A biosimilar biological drug is a biologic that has similar efficacy and safety to the original product.The goal of biosimilar therapy is to provide a cost-effective option that is as effective and safe as the original product.The introduction of biosimilars into clinical practice has raised several clinical concerns, such as disease activation and the development of immunogenicity(1,2).There are very few studies evaluating the effect of multiple switches between biosimilars on patients with inflammatory bowel disease (IBD). In this study, we aimed to evaluate the safety and efficacy of multiple switches between biosimilars in patients with IBD receiving Infliximab (IFX) Patients used the biosimilar available at the hospital pharmacy,because obtaining medication from an outside pharmacy was more difficult based on the patient’s preference.

Methods
The data of 147 patients who were followed at the IBD outpatient clinic of Gazi University Hospital and received IFX treatment were retrospectively reviewed from the hospital information system. 70 patients were excluded from the study due to discontinuation of follow-up, short follow-up duration, or receiving a low number of infliximab doses. A total of 77 patients were included in the study. In Turkey, three commercial IFX preparations are available, one of which is the original product: REMICADE® (Janssen Biotech, Inc., Horsham, PA, USA), REMSIMA™ (Celltron, Inc., Incheon, Korea), and IXIFI® (Pfizer, USA). The commercial formulation used by the patients, the number of biosimilar switches, disease duration, and the presence of disease activation during switches were evaluated.

Results
Of the 77 patients included in the study, 37.7% (n=29) had ulcerative colitis (UC) and 62.3% (n=48) had Crohn’s disease (CD). The average age at diagnosis was 35±14.58 years. Thirty-seven patients had used the same preparation continuously, while 40 patients used different biosimilars. The number of switches ranged from a minimum of 1 to a maximum of 6 times. After switching to biosimilars, only one patient experienced disease activation. There was no statistically significant difference between the patients who had switches and those who did not regarding primary non-response and secondary non-response (p=0.419 and p=0.314, respectively).

Conclusion
In this study, the safety and efficacy of multiple switches between biosimilars in IBD patients receiving IFX were evaluated. Our findings indicate that biosimilars have similar efficacy and safety profiles when compared to the original infliximab products. Our results are consistent with the studies in literature(3,4) . However, long-term effects of switching between biosimilars and original products should be evaluated in more comprehensive studies.

References
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2.Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, et al. The challenge of indication extrapolation for infliximab biosimilars. Biol J Int Assoc Biol Stand. 2014 Jul;42(4):177–83.
3.Hanzel J, Jansen JM, Ter Steege RWF, Gecse KB, D’Haens GR. Multiple Switches From the Originator Infliximab to Biosimilars Is Effective and Safe in Inflammatory Bowel Disease: A Prospective Multicenter Cohort Study. Inflamm Bowel Dis. 2022 Mar;28(4):495–501.
4.Taherzadeh N, Kataery D, Murray C, Shah T. PMO-33 Infliximab biosimilar switching – can you switch more than once? Vol. 70, Gut. 2021. A93.3-A94.