Karin Malíčková1, Dana Ďuricová2, Martin Bortlík3, Miroslav Hind'oš4, Naděžda Machková5, Veronika Hrubá5, Martin Lukáš5, Tomáš Zima4, Milan Lukáš6. 1. Institute of Medical Biochemistry and Laboratory Diagnostics, 1st Medical Faculty and General Teaching Hospital, Charles University, Karlovo náměstí 32, 121 11, Prague, Czech Republic. Electronic address: karin.malickova@vfn.cz. 2. IBD Clinical and Research Centre, Iscare a.s., Jankovcova 1569/2c, 170 00 Prague, Czech Republic; Institute of Pharmacology, 1st Medical Faculty, Charles University, Albertov 4, 128 00 Prague, Czech Republic. 3. IBD Clinical and Research Centre, Iscare a.s., Jankovcova 1569/2c, 170 00 Prague, Czech Republic; Department of Internal Medicine, Military Hospital, Charles University, U vojenské nemocnice 1200, 169 02 Prague, Czech Republic. 4. Institute of Medical Biochemistry and Laboratory Diagnostics, 1st Medical Faculty and General Teaching Hospital, Charles University, Karlovo náměstí 32, 121 11, Prague, Czech Republic. 5. IBD Clinical and Research Centre, Iscare a.s., Jankovcova 1569/2c, 170 00 Prague, Czech Republic. 6. Institute of Medical Biochemistry and Laboratory Diagnostics, 1st Medical Faculty and General Teaching Hospital, Charles University, Karlovo náměstí 32, 121 11, Prague, Czech Republic; IBD Clinical and Research Centre, Iscare a.s., Jankovcova 1569/2c, 170 00 Prague, Czech Republic.
Abstract
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.
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 IBDpatients (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.
Authors: Thomas Van Stappen; Lize Bollen; Niels Vande Casteele; Konstantinos Papamichael; Gert Van Assche; Marc Ferrante; Séverine Vermeire; Ann Gils Journal: Clin Transl Gastroenterol Date: 2016-12-08 Impact factor: 4.488