Switch from biosimilar infliximab CT-P13 to biosimilar infliximab SB-2 in the long-term maintenance therapy in IBD patients – prospective observational study

Czech version

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‘ workplace: 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: Gastroent Hepatol 2023; 77(4): 336-341
Category:
doi: https://doi.org/10.48095/ccgh2023336

Overview

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

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