Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F16%3A10322645" target="_blank" >RIV/00064165:_____/16:10322645 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/16:10322645

Výsledek na webu

<a href="http://dx.doi.org/10.1016/j.biologicals.2015.09.005" target="_blank" >http://dx.doi.org/10.1016/j.biologicals.2015.09.005</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.biologicals.2015.09.005" target="_blank" >10.1016/j.biologicals.2015.09.005</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease

Popis výsledku v původním jazyce

Background: CT-P13 is a biosimilar drug of reference infliximab and is approved in some countries for use in some indications for which reference infliximab is approved, including inflammatory bowel disease (IBD). The CT-P13 formulation is identical to that of reference infliximab and has similar physiochemical characteristics. However, even a small molecular distinction could lead to different behavior of CT-P13 in immunoanalytical detection systems. Aim: To determine the correlation between three different enzyme-linked immunosorbent assays for infliximab detection in the measurement of CT-P13 trough serum levels. Methods: Serum samples (n = 42) from IBD patients (n = 22) treated with CT-P13 Remsima (TM) (Celltrion, Korea) were evaluated in a blinded way in infliximab assays manufactured by (A) Matriks Biotek (Turkey), (B) Theradiag (France), and (C) R-Biopharm (Germany). Results: All assays showed excellent qualitative correlation (Cohen's kappa = 0.90 for A vs. B, 0.76 for A vs. C, and 0.83 for B vs. C). A linear quantitative correlation was satisfactory as well (Spearman's r = 0.91 for A vs. B, 0.86 for A vs. C and 0.92 for B vs. C). Assay C did not detect CT-P13 in 6 samples detected by A and/or B. Conclusion: There is a good correlation of CT-P13 serum level detection between these assays.

Název v anglickém jazyce

Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease

Popis výsledku anglicky

Background: CT-P13 is a biosimilar drug of reference infliximab and is approved in some countries for use in some indications for which reference infliximab is approved, including inflammatory bowel disease (IBD). The CT-P13 formulation is identical to that of reference infliximab and has similar physiochemical characteristics. However, even a small molecular distinction could lead to different behavior of CT-P13 in immunoanalytical detection systems. Aim: To determine the correlation between three different enzyme-linked immunosorbent assays for infliximab detection in the measurement of CT-P13 trough serum levels. Methods: Serum samples (n = 42) from IBD patients (n = 22) treated with CT-P13 Remsima (TM) (Celltrion, Korea) were evaluated in a blinded way in infliximab assays manufactured by (A) Matriks Biotek (Turkey), (B) Theradiag (France), and (C) R-Biopharm (Germany). Results: All assays showed excellent qualitative correlation (Cohen's kappa = 0.90 for A vs. B, 0.76 for A vs. C, and 0.83 for B vs. C). A linear quantitative correlation was satisfactory as well (Spearman's r = 0.91 for A vs. B, 0.86 for A vs. C and 0.92 for B vs. C). Assay C did not detect CT-P13 in 6 samples detected by A and/or B. Conclusion: There is a good correlation of CT-P13 serum level detection between these assays.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

CE - Biochemie

OECD FORD obor

—

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2016

Kód důvěrnosti údajů

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

Název periodika

Biologicals

ISSN

1045-1056

e-ISSN

—

Svazek periodika

44

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

4

Strana od-do

33-36

Kód UT WoS článku

000369464100005

EID výsledku v databázi Scopus

2-s2.0-84952639364