Subcutaneous Absorption Contributes to Observed Interindividual Variability in Adalimumab Serum Concentrations in Crohn's Disease: A Prospective Multicentre Study

Journal of Crohn's & Colitis
Niels Vande CasteeleAnn Gils

Abstract

Therapeutic drug monitoring is used to optimise adalimumab therapy in patients with Crohn's disease [CD]. However, the interindividual variability in drug absorption and the quantitative effect on drug clearance of anti-adalimumab antibodies [AAA], measured with a drug-resistant assay, are unclear. We aimed to characterise adalimumab population pharmacokinetics [PopPK] and identify determinants of interindividual variability in patients with CD. In a prospective multicentre open-label cohort study in 28 patients with CD starting adalimumab therapy peak, intermediate, and trough serum samples were analysed for adalimumab and AAA concentrations using a drug resistant assay. Adalimumab concentration-time data were analysed by non-linear mixed effects modelling and were adequately described by a PopPK model with first-order absorption and one-compartment disposition with linear elimination. Clinical remission at Week 12 [W12] was defined as a Harvey-Bradshaw index ≤4. The absorption rate, volume of distribution, and clearance estimates of a typical patient were respectively 0.343 /day, 7.8 L, and 0.330 L/day. A 4-fold difference in the range of adalimumab concentrations was observed 7 days after the first dose and found to be inver...Continue Reading

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Citations

Jun 11, 2019·Expert Opinion on Drug Metabolism & Toxicology·Raffaella FrancaGabriele Stocco
Jul 16, 2019·Expert Review of Clinical Pharmacology·Anne S StrikMark Löwenberg
Sep 25, 2019·Journal of Crohn's & Colitis·Miles P SparrowXavier Roblin
Aug 20, 2019·Clinical Pharmacology and Therapeutics·Nathalie Van den BergheDebby Thomas
Apr 30, 2020·Alimentary Pharmacology & Therapeutics·Aysha H Al-AniBritt Christensen
Jul 14, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Pavine L C LefevreNiels Vande Casteele
Jun 11, 2019·Expert Review of Clinical Immunology·Konstantinos PapamichaelAdam S Cheifetz
Mar 31, 2021·Inflammatory Bowel Diseases·Claire LiefferinckxDenis Franchimont
Aug 14, 2021·The American Journal of Gastroenterology·Adam S CheifetzKonstantinos Papamichael
Sep 25, 2021·Alimentary Pharmacology & Therapeutics·Jurij HanzelRon A A Mathôt

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