Multiple infliximab biosimilar switches appear to be safe and effective in a real‐world inflammatory bowel disease cohort

• DOI: 10.1002/ueg2.12357
• Publication Date: 2023-02-18T17:58:51Z
• Authors: Beatriz Gros; Nikolas Plevris; Nathan Constantin...; Mathew Lyons; Claire O'Hare; Colin Noble; Ian D. Arnott; Gareth‐Rhys Jones; Charlie W. Lees; Lauranne A. A. P....
• Keywords: Biosimilar; Faecal calprotectin; Clinical endpoint

Abstract Background Switching from originator infliximab (IFX) to biosimilar IFX is effective and safe. However, data on multiple switching are scarce. The Edinburgh inflammatory bowel disease (IBD) unit has undertaken three switch programmes: (1) Remicade CT‐P13 (2016), (2) SB2 (2020), (3) (2021). Objective primary endpoint of this study was assess persistence following SB2. Secondary endpoints included stratified by the number switches (single, double triple), effectiveness safety. Methods We performed a prospective, observational, cohort study. All adult IBD patients underwent an elective CT‐P13. Patients were reviewed in virtual biologic clinic with protocol driven collection clinical activity, C‐reactive protein (CRP), faecal calprotectin (FC), trough/antibody levels, drug survival. Results 297 (CD n = 196 [66%], ulcerative colitis/inflammatory unclassified 101, [34%]) switched (followed‐up: 7.5 months [6.8–8.1]). This third, second first for 67/297 (22.5%), 138/297 (46.5%) 92/297 (31%) respectively. 90.6% remained during follow‐up. not independently associated after adjusting confounders. Clinical ( p 0.77), biochemical (CRP ≤5 mg/ml; 0.75) biomarker (FC<250 µg/g; 0.63) remission comparable at baseline, week 12 24. Conclusion Multiple successive biosimilars safe IBD, irrespective switches.