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Ther Drug Monit. 2019 Feb 26. doi: 10.1097/FTD.0000000000000629. [Epub ahead of print]

Comparison of immunoassays for measuring serum levels of golimumab and antibodies against golimumab in ulcerative colitis: a retrospective observational study.

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Laboratoire d'Immunologie et d'Immunomonitoring, CIC Inserm 1408, GIMAP EA3064, CHU Saint-Etienne, France.
Unité de Mathématiques, Université de Lyon, France.
Sanquin Diagnostic Services, Biologics Laboratory, Amsterdam, The Netherlands.
Janssen Research and Development, LLC, Spring House, PA, USA.
MSD France (Merck Sharp & Dohme laboratories).
MSD International, Switzerland.
Department of Gastroenterology, Hospices Civils de Lyon, Lyon-Sud Hospital, Pierre-Benite, France & INSERM U1111, International Center for Research in Infectiology (CIRI), Lyon, France.
Department of Pharmaceutical and Pharmacological Sciences, Laboratory for Therapeutic and Diagnostic Antibodies, KU Leuven, Belgium.
Service de Gastro-Entérologie-Hépatologie, CHU de Saint-Etienne (France).



Golimumab is a monoclonal anti-tumor necrosis factor (TNF) alpha antibody, used in ulcerative colitis (UC) with an exposure-response relationship. The goal of the present study was to compare results obtained with different immunoassays (golimumab and anti-golimumab antibodies trough levels).


The present study was based on samples from 78 UC patients on golimumab treatment. Golimumab was quantified by either an anti-IgG detection antibody (Theradiag) or an antibody directed against golimumab (Sanquin, KU Leuven and Janssen R&D). Bridging drug-sensitive ELISA assays (Theradiag, Janssen R&D, KU Leuven), a bridging drug-tolerant ELISA assay (Janssen R&D), and a radioimmunoassay (Sanquin) were used to quantify Anti-drug Antibody (ADA).


Median serum golimumab levels were 4.5, 3.5, 4.9, and 2.4 µg/mL with Theradiag, Sanquin, KU Leuven and Janssen R&D assay, respectively (p<0.05). Correlation coefficients between assays ranged from 0.9 to 0.97. When using the KU Leuven and Janssen R&D assays, 86% of samples were in the same quartile of distribution of values, and for Sanquin and Janssen R&D assays, this overlap was 80%. The concordance observed for the other pairs was 83% (Sanquin/KU Leuven R&D), 71% (Theradiag/KU Leuven), and 68% (Theradiag/Janssen R&D and Theradiag/Sanquin). The specificity of assays for golimumab was demonstrated. ADAs were detected in 28.2% of the samples with the Janssen R&D drug-tolerant assay and in the same two patients by the three other assays.


Performances of these immunoassays were similar in terms of quality but differences in the quantitative results point to the importance of using the same assay consistently to monitor a patient's treatment.

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