Céline Desvignes1,2, Soujanya R Edupuganti1, François Darrouzain1,2, Anne-Claire Duveau1,2, Amy Loercher3, Gilles Paintaud1,2, Denis Mulleman1,4. 1. 1Université François Rabelais de Tours, CNRS UMR 7292, Tours, France. 2. 2CHRU de Tours, Laboratory of Pharmacology-Toxicology, Tours, France. 3. 4Clinical Immunology, GlaxoSmithKline, Upper Merion, 709 Swedeland Road, Kings of Prussia, PA 19406, USA. 4. 3CHRU de Tours, Department of Rheumatology, Tours, France.
Abstract
BACKGROUND: Adalimumab is a therapeutic antibody used for treating inflammatory diseases. To understand interindividual PK variability, there is a need to develop and validate an assay to measure serum adalimumab concentrations. METHODS: An ELISA was developed on microtiter plates coated with TNF-α. Seven nonzero adalimumab standards ranging from 0.05 to 50 mg/l and three quality controls (0.2, 2.5 and 7 mg/l) were tested for their intra and interday precision on six occasions. RESULTS: The LOD, LLOQ and ULOQ of the assay were 0.022, 0.073 and 9 mg/l, respectively. CONCLUSION: This method is accurate, reproducible and may be useful for PK studies and for therapeutic drug monitoring of adalimumab.
BACKGROUND:Adalimumab is a therapeutic antibody used for treating inflammatory diseases. To understand interindividual PK variability, there is a need to develop and validate an assay to measure serum adalimumab concentrations. METHODS: An ELISA was developed on microtiter plates coated with TNF-α. Seven nonzero adalimumab standards ranging from 0.05 to 50 mg/l and three quality controls (0.2, 2.5 and 7 mg/l) were tested for their intra and interday precision on six occasions. RESULTS: The LOD, LLOQ and ULOQ of the assay were 0.022, 0.073 and 9 mg/l, respectively. CONCLUSION: This method is accurate, reproducible and may be useful for PK studies and for therapeutic drug monitoring of adalimumab.
Authors: Emilie Ducourau; Theo Rispens; Marine Samain; Emmanuelle Dernis; Fabienne Le Guilchard; Lucia Andras; Aleth Perdriger; Eric Lespessailles; Antoine Martin; Grégoire Cormier; Thomas Armingeat; Valérie Devauchelle-Pensec; Elisabeth Gervais; Benoit Le Goff; Annick de Vries; Eric Piver; Gilles Paintaud; Céline Desvignes; David Ternant; Hervé Watier; Philippe Goupille; Denis Mulleman Journal: RMD Open Date: 2020-01-09