Serum trough infliximab levels: A comparison of three different immunoassays for the monitoring of CT-P13 (infliximab) treatment in patients with inflammatory bowel disease
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, srovnávací studie, časopisecké články, práce podpořená grantem
PubMed
26603635
DOI
10.1016/j.biologicals.2015.09.005
PII: S1045-1056(15)00110-4
Knihovny.cz E-zdroje
- Klíčová slova
- Biosimilar, CT-P13, Enzyme-linked immunosorbent assay, Inflammatory bowel disease, Infliximab,
- MeSH
- idiopatické střevní záněty krev farmakoterapie MeSH
- imunoanalýza metody MeSH
- infliximab aplikace a dávkování farmakokinetika MeSH
- lidé MeSH
- monitorování léčiv metody MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky MeSH
- práce podpořená grantem MeSH
- srovnávací studie MeSH
- Názvy látek
- infliximab MeSH
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™ (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.
Citace poskytuje Crossref.org
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