P745 Multiple infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort
Gros, B.(1,2)*;Plevris, N.(1);Constantine-Cooke, N.(3,4);Lyons, M.(1);O’Hare, C.(1,5);Noble, C.(1);Arnott, I.D.(1);Jones, G.R.(1,6);Lees, C.W.(1,4);Derikx, L.A.A.P.(1,7,8);
(1)Western General Hospital, Edinburgh IBD Unit, Edinburgh, United Kingdom;(2)Reina Sofía University Hospital, Gastroenterology and hepatology department, Cordoba, Spain;(3)Institute of Genetics and Cancer- University of Edinburgh, MRC Human Genetics Unit-, Edinburgh, United Kingdom;(4)Institute of Genetics and Cancer- University of Edinburgh, Centre for Genomics and Experimental Medicine, Edinburgh, United Kingdom;(5)Western General Hospital, Edinburgh Pharmacy Unit, Edinburgh, United Kingdom;(6)The Queen's Medical Research Institute- University of Edinburgh, Centre for Inflammation Research, Edinburgh, United Kingdom;(7)Erasmus MC- University Medical Centre Rotterdam, Department of Gastroenterology and Hepatology, Rotterdam, The Netherlands;(8)Department of Gastroenterology and Hepatology- Radboud University Medical Center, Inflammatory Bowel Disease Center, Nijmegen, The Netherlands;
Background
Switching from originator to biosimilar infliximab (IFX) is effective and safe. However, data on multiple switching are scarce. The Edinburgh IBD unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021). The primary endpoint of this study was to assess CT-P13 persistence following switch from SB2. Secondary endpoints included persistence stratified by the number of biosimilar switches (single, double and triple), effectiveness and safety.
Methods
We performed a prospective, observational, cohort study. All adult IBD patients on IFX biosimilar SB2 underwent an elective switch to CT-P13. Patients were reviewed in a virtual biologic clinic with protocol driven collection of clinical disease activity, CRP, faecal calprotectin (FC), IFX trough / antibody levels, and drug survival.
Results
297 patients (CD n=196 [66%], UC/IBDU n=101, [34%]) were switched. This was the third, second and first IFX switch for 67 /297 (22.5%), 138 /297 (46.5%) and 92 /297 (31%) of the cohort respectively. Patients who underwent multiple IFX biosimilar switches had longer disease duration (p=0.0001) and IFX duration (p=0.0001) and were less often on combination therapy with an immunomodulator (p=0.0001).
90.6% of patients remained on IFX during a median follow-up of 7.5 months [6.8-8.1] (figure 1). The number of switches was not independently associated with IFX persistence after adjusting for confounders (table 1). Clinical (p=0.77), biochemical (CRP ≤5mg/mL; p=0.75) and faecal biomarker (FC<250µg/g; p=0.63) remission were comparable at baseline, week 12 and week 24 (figure 2).
Table 1
| Variable | Univariable Cox Regression | Multivariable Cox Regression* | ||||
|---|---|---|---|---|---|---|
| Hazard Ratio | 95% CI | p | Hazard Ratio | 95% CI | p | |
| Disease duration | 0.79 | 0.56-1-11 | 0.17 | |||
| Duration of IFX treatment | 0.514 | 0.35-0.76 | 0.001 | 0.77 | 0.62-0.95 | 0.015 |
| UC/IBDU versus CD | 0.32 | 0.15-0.68 | 0.003 | 2.69 | 1.19-6.06 | 0.018 |
| Perianal disease | 1.61 | 0.56-4.66 | 0.38 | |||
| Biologic/small molecule naïve | 0.38 | 0.15-0.94 | 0.037 | |||
| Number of switches | 0.40 | 0.22-0.73 | 0.003 | |||
| Clinical remission at switch | 1.34 | 0.57-3.15 | 0.50 | |||
| CRP >5mg/L at switch | 2.96 | 1.34-6.54 | 0.007 | 3.21 | 1.43-7.24 | 0.005 |
| FC ≥250 μg/gr at switch | 1.57 | 0.52-4.69 | 0.40 | |||
| IFX antibodies at switch | 5.44 | 2.47-11.99 | <0.0001 | 5.81 | 2.63-12.84 | <0.0001 |
Conclusion
Multiple successive switches from IFX originator to biosimilars are effective and safe in patients with IBD, irrespective of the number of IFX switches.