Dried blood samples can support monitoring of infliximab concentrations in patients with inflammatory bowel disease: A clinical validation

被引：32

作者：

Berends, Sophie E. ^{[1
,2
]}

D'Haens, Geert R. A. M. ^{[2
]}

Schaap, Tiny ^{[3
]}

de Vries, Annick ^{[3
]}

Rispens, Theo ^{[4
]}

Bloem, Karien ^{[3
]}

Mathot, Ron A. A. ^{[1
]}

机构：

[1] Amsterdam Univ Med Ctr, Dept Hosp Pharm, Amsterdam, Netherlands

[2] Amsterdam Univ Med Ctr, Dept Gastroenterol & Hepatol, Amsterdam, Netherlands

[3] Sanquin Diagnost Serv, Biol Lab, Bioanal, Amsterdam, Netherlands

[4] Sanquin Res & Landsteiner Lab, Dept Immunopathol, Amsterdam, Netherlands

来源：

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY | 2019年 / 85卷 / 07期

关键词：

biologicals; clinical pharmacology; gastroenterology; immunology; therapeutic drug monitoring; MONOCLONAL-ANTIBODIES; SPOTS; OUTCOMES;

D O I：

10.1111/bcp.13939

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Aims Therapeutic drug monitoring (TDM) can optimize the efficacy of infliximab (IFX) in patients with inflammatory bowel disease (IBD). Because of the delay between blood samples taken at trough and availability of results, dose adjustments can only be carried out at the next infusion, typically 8 weeks later. Dried blood samples (DBS) performed at home to measure IFX concentrations can reduce the time to adapt dose/dosing interval. Here, we aimed to validate the clinical application of DBS for IFX in IBD patients and to evaluate the feasibility of home sampling. Methods DBS results from 40 IBD patients on IFX treatment were compared to serum sample results at trough, peak, and 3-5 weeks after IFX infusion. Subsequently, patients performed DBS home sampling one week before the next IFX infusion. These were compared to serum concentrations as predicted by Bayesian analysis. Results IFX concentrations from finger prick and venous puncture correlate well. DBS IFX concentrations showed high correlation with serum IFX concentrations (Spearman correlation: >= 0.965), without bias. Passing-Bablok regression for IFX concentrations in DBS from home sampling also showed no bias (intercept: 1.02 mg L-1 (95% CI -1.77-2.04 mg L-1), slope: 0.82 (95% CI 0.63-1.40)), with reasonable correlation (Spearman correlation: 0.671). Conclusions Timely adjustment of IFX dose/dosing interval can be facilitated by IFX concentration measurement in home-sampled DBS. DBS is a reliable method to measure IFX and can be used to predict IFX trough concentrations.

引用

页码：1544 / 1551

页数：8

共 27 条

[1] THE CONCISE GUIDE TO PHARMACOLOGY 2017/18: Catalytic receptors [J].

Alexander, Stephen P. H. ;

Fabbro, Doriano ;

Kelly, Eamonn ;

Marrion, Neil V. ;

Peters, John A. ;

Faccenda, Elena ;

Harding, Simon D. ;

Pawson, Adam J. ;

Sharman, Joanna L. ;

Southan, Christopher ;

Davies, Jamie A. .

BRITISH JOURNAL OF PHARMACOLOGY, 2017, 174 :S225-S271

[2] Is There a Role for Therapeutic Drug Monitoring of Anti-TNF Monoclonal Antibodies in Inflammatory Bowel Disease [J].

Baert, Filip .

DIGESTIVE DISEASES, 2015, 33 :70-77

[3] Prediction-Corrected Visual Predictive Checks for Diagnosing Nonlinear Mixed-Effects Models [J].

Bergstrand, Martin ;

Hooker, Andrew C. ;

Wallin, Johan E. ;

Karlsson, Mats O. .

AAPS JOURNAL, 2011, 13 (02) :143-151

[4]

Bilic-Zulle L, 2011, BIOCHEM MEDICA, V21, P49

[5] Capillary blood microsampling to determine serum biopharmaceutical concentration: Mitra® microsampler vs dried blood spot [J].

Bloem, Karien ;

Schaap, Tiny ;

Boshuizen, Ronald ;

Kneepkens, Eva L. ;

Wolbink, Gerrit J. ;

de Vries, Annick ;

Rispens, Theo .

BIOANALYSIS, 2018, 10 (11) :815-823

[6] Detection of infliximab levels and anti-infliximab antibodies: a comparison of three different assays [J].

Casteele, N. Vande ;

Buurman, D. J. ;

Sturkenboom, M. G. G. ;

Kleibeuker, J. H. ;

Vermeire, S. ;

Rispens, T. ;

van der Kleij, D. ;

Gils, A. ;

Dijkstra, G. .

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2012, 36 (08) :765-771

[7] Increasing Infliximab Dose Based on Symptoms, Biomarkers, and Serum Drug Concentrations Does Not Increase Clinical, Endoscopic, and Corticosteroid-Free Remission in Patients With Active Luminal Crohn's Disease [J].

D'Haens, Geert ;

Vermeire, Severine ;

Lambrecht, Guy ;

Baert, Filip ;

Bossuyt, Peter ;

Pariente, Benjamin ;

Buisson, Anthony ;

Bouhnik, Yoram ;

Filippi, Jerome ;

Vander Woude, Janneke ;

Van Hootegem, Philippe ;

Moreau, Jacques ;

Louis, Edouard ;

Franchimont, Denis ;

De Vos, Martine ;

Mana, Fazia ;

Peyrin-Biroulet, Laurent ;

Brixi, Hedia ;

Allez, Matthieu ;

Caenepeel, Philip ;

Aubourg, Alexandre ;

Oldenburg, Bas ;

Pierik, Marieke ;

Gils, Ann ;

Chevret, Sylvie ;

Laharie, David .

GASTROENTEROLOGY, 2018, 154 (05) :1343-+

[8] Volumetric Absorptive Microsampling: A Dried Sample Collection Technique for Quantitative Bioanalysis [J].

Denniff, Philip ;

Spooner, Neil .

ANALYTICAL CHEMISTRY, 2014, 86 (16) :8489-8495

[9] Dried Blood Spot Methods in Therapeutic Drug Monitoring: Methods, Assays, and Pitfalls [J].

Edelbroek, Peter M. ;

van der Heijden, Jacques ;

Stolk, Leo M. L. .

THERAPEUTIC DRUG MONITORING, 2009, 31 (03) :327-336

[10] Pharmacokinetic Properties of Infliximab in Children and Adults with Crohn's Disease: A Retrospective Analysis of Data from 2 Phase III Clinical Trials [J].

Fasanmade, Adedigbo A. ;

Adedokun, Omoniyi J. ;

Blank, Marion ;

Zhou, Honghui ;

Davis, Hugh M. .

CLINICAL THERAPEUTICS, 2011, 33 (07) :946-964

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