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

Result code in 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>

Alternative codes found

RIV/00216208:11110/16:10322645

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

CE - Biochemistry

OECD FORD branch

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Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2016

Confidentiality

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

Name of the periodical

Biologicals

ISSN

1045-1056

e-ISSN

—

Volume of the periodical

44

Issue of the periodical within the volume

1

Country of publishing house

GB - UNITED KINGDOM

Number of pages

4

Pages from-to

33-36

UT code for WoS article

000369464100005

EID of the result in the Scopus database

2-s2.0-84952639364