Format

Send to

Choose Destination
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.

Author information

1
Laboratoire d'Immunologie et d'Immunomonitoring, CIC Inserm 1408, GIMAP EA3064, CHU Saint-Etienne, France.
2
Unité de Mathématiques, Université de Lyon, France.
3
Sanquin Diagnostic Services, Biologics Laboratory, Amsterdam, The Netherlands.
4
Janssen Research and Development, LLC, Spring House, PA, USA.
5
MSD France (Merck Sharp & Dohme laboratories).
6
MSD International, Switzerland.
7
Department of Gastroenterology, Hospices Civils de Lyon, Lyon-Sud Hospital, Pierre-Benite, France & INSERM U1111, International Center for Research in Infectiology (CIRI), Lyon, France.
8
Department of Pharmaceutical and Pharmacological Sciences, Laboratory for Therapeutic and Diagnostic Antibodies, KU Leuven, Belgium.
9
Service de Gastro-Entérologie-Hépatologie, CHU de Saint-Etienne (France).

Abstract

BACKGROUND:

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).

METHODS:

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).

RESULTS:

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.

CONCLUSION:

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.

Supplemental Content

Full text links

Icon for Wolters Kluwer
Loading ...
Support Center