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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F67985807%3A_____%2F23%3A00577160" target="_blank" >RIV/67985807:_____/23:00577160 - isvavai.cz</a>

Výsledek na webu

<a href="https://dx.doi.org/10.48095/ccgh2023336" target="_blank" >https://dx.doi.org/10.48095/ccgh2023336</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.48095/ccgh2023336" target="_blank" >10.48095/ccgh2023336</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

10103 - Statistics and probability

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Gastroenterologie a hepatologie

ISSN

1804-7874

e-ISSN

—

Svazek periodika

77

Číslo periodika v rámci svazku

4

Stát vydavatele periodika

CZ - Česká republika

Počet stran výsledku

6

Strana od-do

336-341

Kód UT WoS článku

—

EID výsledku v databázi Scopus

2-s2.0-85174406531