Switch from biosimilar infliximab CT-P13 to biosimilar infliximab SB-2 in the long-term maintenance therapy in IBD patients – prospective observational study
Authors:
M. Lukáš 1
; V. Hrubá 1
; J. Reissigová 2
; K. Černá 1
; N. Machková 1; D. Ďuricová 1
; M. Kolář 1
; K. Vlková 1; L. Čermáková 1; M. Lukáš Jr 1
Authors place of work:
Klinické a výzkumné centrum pro střevní záněty, Klinické centrum ISCARE a. s. a 1. LF UK v Praze
1; Ústav informatiky AV ČR, Praha
2
Published in the journal:
Gastroent Hepatol 2023; 77(4): 336-341
Category:
doi:
https://doi.org/10.48095/ccgh2023336
Summary
Introduction: Therapeutical switch from originator to biosimilar infliximab has been proved as effective and safety procedure. We have a few information about non-medical swich from one biosimilar to the another biosimilar infiximab. Aim: This is a prospective observational study from one tercial IBD center, performed in 2021 and 2022 which was focused on efficacy and safety after switch from infliximab CT-P13 to infliximab SB-2 in patients with IBD. Methods: The cohort group comprised with 287 patients with IBD who have been consecutively treated with infliximab CT-P13 and they were switched to infliximab SB-2. All the re cruited patients were in clinical and biological sustained remission at mean for 6 months before the switch. Results: We proved that persistence on infliximab SB-2 therapy after the switch was 86.4% of treated patients, no significant changes in clinical inflammatory activities and biological parameters have been detected after the switch. The therapy termination due to side effects or loss of response in 39 patients (13.9%) has been detected due to lost of clinical response, side effects or lost of follow-up. No higher immunogenicity after the switch was found. Conclusion: Non-medical switch from one biosimilar infliximab (CT-P13) to another one (SB-2) was not associated with higher risks of disease destabilisation or immunogenicity.
Keywords:
inflammatory bowel disease – biosimilar infliximab CT-P13 – biosimilar infliximab SB-2 – therapeutical switch
Zdroje
1. Lukáš M. Přínos biosimilárních monoklonálních protilátek v terapii idiopatických střevních zánětů. Gastroent Hepatol 2022; 76 (5): 447–452. doi: 10.48095/ccgh2022447.
2. Jorgensen KK, Olsen IC, Goll GL et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintenance treatment with original infliximab (Nor-Switch): a randomized 52 week, double blind, non-inferiority study. Lancet 2017; 389 (10086): 2304–2316. doi: 10.1016/S0140-6736 (17) 30068-5.
3. Lukas M, Kolar M, Reissigová K et al. A switch from originator adalimumab to the biosimilar SB5 in patients with Crohn’s disease: an analysis ot two propensity score-matched cohorts. Scand J Gastroenterol 2022; 57 (7): 814–824. doi: 10.1080/00365521.2022.2041082.
4. Lukáš M, Ďuricová D. Zkušenosti s biologickou léčbou v Klinickém centru ISCARE. In: Idiopatické střevní záněty II. Nové trendy a mezioborové souvislosti. Praha: Grada Publishing 2021; 177–202.
5. Hanzel J, Jarisen JM, Ter Steege RW et al. Multiple switches from the originator infliximab to biosimilar is effective and safe in inflammatory bowel disease: A prospective multicenter cohort study. Inflamm Bowel Dis 2022; 26 (4): 495–501. doi: 10.1093/ibd/izab099.
6. Di Giuseppe D, Lindstrom U, Bower H et al. Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden. Rheumatology 2022; 61 (9): 3596–3605. doi: 10.1093/rheumatology/keab933.
7. Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. 2022 [online]. Dostupné z: statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines – EMA review following PROM endorsement (europa.eu).
8. Noor NM, Sousa P, Bettenworth D et al. ECCO topical review on biological treatment cycles in Crohn’s disease. J Crohns Colitis 2023; 17 (7): 1031–1045. doi: 10.1093/ecco-jcc/jjad001.
Štítky
Paediatric gastroenterology Gastroenterology and hepatology SurgeryČlánok vyšiel v časopise
Gastroenterology and Hepatology
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