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;
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.
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.
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).
|Variable||Univariable Cox Regression||Multivariable Cox Regression*|
|Hazard Ratio||95% CI||p||Hazard Ratio||95% CI||p|
|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|
|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|
Multiple successive switches from IFX originator to biosimilars are effective and safe in patients with IBD, irrespective of the number of IFX switches.