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

详细信息    查看全文

• 作者：Karin Malí ; čková ; ^a ; ^{karin.malickova@vfn.cz" class="auth_mail" title="E-mail the corresponding author} ; Dana Ďuricová ; ^b ; ^c ; Martin Bortlí ; k^b ; ^d ; Miroslav Hind&rsquo ; o&scaron ; ^a ; Naděžda Machková ; ^b ; Veronika Hrubá ; ^b ; Martin Luká ; &scaron ; ^b ; Tomá ; &scaron ; Zima^a ; Milan Luká ; &scaron ; ^a ; ^b
• 关键词：Infliximab ; Biosimilar ; CT-P13 ; Inflammatory bowel disease ; Enzyme-linked immunosorbent assay
• 刊名：Biologicals
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：44
• 期：1
• 页码：33-36
• 全文大小：461 K

文摘

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.