Biosimilar infliximab in anti-TNF-naïve IBD patients - 1-year clinical follow-up
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F16%3A10330480" target="_blank" >RIV/00064165:_____/16:10330480 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00216208:11110/16:10330480 RIV/00064203:_____/16:10330480
Výsledek na webu
<a href="http://www.prolekare.cz/linkout/59897" target="_blank" >http://www.prolekare.cz/linkout/59897</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.14735/amgh2016514" target="_blank" >10.14735/amgh2016514</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Biosimilar infliximab in anti-TNF-naïve IBD patients - 1-year clinical follow-up
Popis výsledku v původním jazyce
Biosimilar infliximab (IFX) has been approved for the treatment of inflammatory bowel disease (IBD) in the European Union since September 2013. The approval process included extrapolation of clinical data from other indications, namely, rheumatoid arthritis and ankylosing spondylitis. Data from clinical practice are therefore desirable to confirm the efficacy and safety of biosimilar IFX in the IBD population. Evidence of the long-term efficiency and safety of maintenance treatment with biosimilar IFX in patients with IBD is sparse. Methods: Data from consecutive patients with Crohn's disease (CD) and ulcerative colitis (UC) who were started on biosimilar IFX between January 2015 and May 2016 at our center were analyzed. Patients were assessed as non-responders, partial responders, or complete responders based on clinical, endoscopic, and laboratory parameters. Besides clinical and endoscopic evaluation, C reactive protein levels, fecal calprotectin levels, blood counts, IFX trough levels, and anti-IFX antibody levels were measured. All adverse events were recorded. Final analysis was performed at week 54.
Název v anglickém jazyce
Biosimilar infliximab in anti-TNF-naïve IBD patients - 1-year clinical follow-up
Popis výsledku anglicky
Biosimilar infliximab (IFX) has been approved for the treatment of inflammatory bowel disease (IBD) in the European Union since September 2013. The approval process included extrapolation of clinical data from other indications, namely, rheumatoid arthritis and ankylosing spondylitis. Data from clinical practice are therefore desirable to confirm the efficacy and safety of biosimilar IFX in the IBD population. Evidence of the long-term efficiency and safety of maintenance treatment with biosimilar IFX in patients with IBD is sparse. Methods: Data from consecutive patients with Crohn's disease (CD) and ulcerative colitis (UC) who were started on biosimilar IFX between January 2015 and May 2016 at our center were analyzed. Patients were assessed as non-responders, partial responders, or complete responders based on clinical, endoscopic, and laboratory parameters. Besides clinical and endoscopic evaluation, C reactive protein levels, fecal calprotectin levels, blood counts, IFX trough levels, and anti-IFX antibody levels were measured. All adverse events were recorded. Final analysis was performed at week 54.
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
FE - Ostatní obory vnitřního lékařství
OECD FORD obor
—
Návaznosti výsledku
Projekt
—
Návaznosti
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Ostatní
Rok uplatnění
2016
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Gastroenterologie a hepatologie
ISSN
1804-7874
e-ISSN
—
Svazek periodika
70
Číslo periodika v rámci svazku
6
Stát vydavatele periodika
CZ - Česká republika
Počet stran výsledku
9
Strana od-do
514-522
Kód UT WoS článku
—
EID výsledku v databázi Scopus
2-s2.0-85012863835