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

0577160 - ÚI 2024 RIV CZ eng J - Journal Article
Lukáš, M. - Hrubá, V. - Reissigová, Jindra - Černá, K. - Machková, N. - Ďuricová, D. - Kolář, M. - Vlková, K. - Čermáková, L. - Lukáš Jr., M.
Switch from biosimilar infliximab CT-P13 to biosimilar infliximab SB-2 in the long-term maintenance therapy in IBD patients – prospective observational study.
Gastroenterologie a hepatologie. Roč. 77, č. 4 (2023), s. 336-341. ISSN 1804-7874
Institutional support: RVO:67985807
Keywords : inflammatory bowel disease * biosimilar infliximab CT-P13 * biosimilar infliximab SB-2 * therapeutical switch
OECD category: Statistics and probability
Method of publishing: Limited access
https://dx.doi.org/10.48095/ccgh2023336

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 recruited 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. CUNCLUSION: 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.
Permanent Link: https://hdl.handle.net/11104/0346393