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Switch from biosimilar infliximab CT-P13 to biosimilar infliximab SB-2 in the long-term maintenance therapy in IBD patients – prospective observational study
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SYSNO ASEP 0577160 Document Type J - Journal Article R&D Document Type Journal Article Subsidiary J Článek ve SCOPUS Title Switch from biosimilar infliximab CT-P13 to biosimilar infliximab SB-2 in the long-term maintenance therapy in IBD patients – prospective observational study Author(s) Lukáš, M. (CZ)
Hrubá, V. (CZ)
Reissigová, Jindra (UIVT-O) SAI, RID
Černá, K. (CZ)
Machková, N. (CZ)
Ďuricová, D. (CZ)
Kolář, M. (CZ)
Vlková, K. (CZ)
Čermáková, L. (CZ)
Lukáš Jr., M. (CZ)Source Title Gastroenterologie a hepatologie - ISSN 1804-7874
Roč. 77, č. 4 (2023), s. 336-341Number of pages 6 s. Publication form Print - P Language eng - English Country CZ - Czech Republic Keywords inflammatory bowel disease ; biosimilar infliximab CT-P13 ; biosimilar infliximab SB-2 ; therapeutical switch OECD category Statistics and probability Method of publishing Limited access Institutional support UIVT-O - RVO:67985807 EID SCOPUS 85174406531 DOI https://doi.org/10.48095/ccgh2023336 Annotation 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. Workplace Institute of Computer Science Contact Tereza Šírová, sirova@cs.cas.cz, Tel.: 266 053 800 Year of Publishing 2024 Electronic address https://dx.doi.org/10.48095/ccgh2023336
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