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The handle http://hdl.handle.net/1887/61042 holds various files of this Leiden University dissertation.
Author: Reijers, J.A.A.
Title: Sticky & Dirty Proteins – or on the poorly characterised, peculiar, pharmacokinetic and immunostimulatory aspects of biopharmaceuticals
Issue Date: 2018-03-14
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a ppen di x
J
oannes a.a. reijers was born in the eldest city of the county of Holland (Dor- drecht) ad 1985, and studied medicine at the eldest university of the Northern Nether- lands (Leiden University). Both the doctoral and the medical exams were passed with honours, in respec- tively 2008 and 2010.Thereafter, he remained associated with the aca- demic hospital, the Leiden University Medical Center, in the function of resident at the department of inter- nal medicine.
From 2011 through 2016, Mr. Reijers worked at the Centre for Human Drug Research in Leiden, where all research was conducted, which culminated in this thesis. During this period, he became a registered clinical pharmacologist and member at the Dutch Society of Clinical Pharmacology and Biopharmacy.
Mr. Reijers returned to clinical practice and to the alma mater in 2016, starting the training for rheuma- tologist. As part of this specialisation, he is currently following a 3-year course in internal medicine at the regional hospital in the historical city of Gouda.
curriculum vitæ
1 Wisman LAB, De Cock EPM, Reijers JAA, et al. A phase i dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers. Clin Drug Investig 2014;
34: 887–94.
2 Reijers JAA, Burggraaf J. Trastuzumab induces an immediate, transient volume increase in humans:
a randomised placebo-controlled trial. EBioMedicine 2015; 2: 953–9.
3 Kallend DG, Reijers JAA, Bellibas SE, et al. A single infusion of mdco-216 (ApoA-1 Milano/popc) increases abca1- mediated cholesterol efflux and pre-beta 1 hdl in healthy volunteers and patients with stable coronary artery disease.
Eur Hear journal Cardiovasc Pharmacother 2016; 2: 23–9.
4 Reijers JAA, van Donge T, Schepers FML, Burggraaf J, Stevens J. Use of population approach non-linear mixed effects models in the evaluation of biosimilarity of monoclonal antibodies. Eur J Clin Pharmacol 2016; 72:
1343–52 (chapter 1).
5 Dillingh MR, Reijers JAA, Malone KE, et al. Clinical evalua- tion of Humira® biosimilar ons-3010 in healthy volunteers:
focus on pharmacokinetics and pharmacodynamics. Front Immunol 2016; 7: 508.
6 Monnet E, Lapeyre G, Poelgeest E van, Jacqmin P, Graaf K, Reijers J, et al. Evidence of ni-0101 pharmacological activity,
an anti-tlr4 antibody, in a randomized phase i dose escalation study in healthy volunteers receiving lps.
Clin Pharmacol Ther 2017; 101: 200–8.
7 Reijers JA, Dane M, Malone K, Burggraaf J, Moerland M.
Characterisation of immunostimulation by trastuzumab in responders and non-responders. J Pharmacol Clin Toxicol 2017; 5: 1075 (chapter 4).
8 Reijers JAA, Kallend DG, Malone KE, et al. mdco-216 does not induce adverse immunostimulation, in contrast to its prede- cessor etc-216. Cardiovasc drugs Ther 2017; 31: 381–9 (chapter 5).
9 Reijers JAA, Dane MJC, van Zonneveld AJ, Burggraaf J, Moerland M. Potential influence of endothelial adsorption on the delayed time to maximum concentration of biopharmaceuticals. Eur J Drug Metab Pharmacokinet 2018;
43: 103–13 (chapter 2).
10 Reijers JAA, Moerland M, Burggraaf J. Remarkable pharma- cokinetics of monoclonal antibodies: a quest for an explana- tion. Clin Pharmacokinet 2017; 56: 1081–9 (chapter 3).
11 Ducore J, Lawrence JB, Simpson M, Boggio L, Bellon A, Burggraaf J, Stevens J, Moerland M, Frieling J, Reijers J, Wang M. Safety and dose-dependency of eptacog beta (activated) in a dose escalation study of non-bleeding congenital haemophilia a or b patients, with or without inhibitors. Haemophilia 2017; 23: 844–51.
bibliography
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pecial thanks are extended to the operational crew of chdr, without whose tireless efforts the clinical trials – of which the data were used in chapters 1, 4, and 5 – would not have been possible. Particularly, Mr. Gerrit A. van der Luijt is acknowledged for his assistance in managing the conduct of these trials and for his overall moral as well as friendly support. Ms. Tess D. Woutman and Ms. Monique van der Linden are recognised for their roles in replicating the intravenous administration procedures described in chapter 2.Furthermore, expressions of gratitude are offered to the scientifical staff of chdr, especially, the pro- motores & copromotor, Ms. Annelieke C. Kruithof, Dr. Marlous R. Dillingh, Mr. Willem A.J. Birkhoff, Dr. Jan Freijer. Together with M(r)s. Helma F.M.
Nederend, Mlle. Baukje du Bois, and M(r)s. Sabine G.J. Deferme, they have helped shape hypotheses and opinions – many of which formed the basis of the work presented here – during countless dis- cussions, in-depth conversations, and memorable soirées.
Centre for Human Drug Research, Leiden, The Netherlands
• J. Burggraaf
• A.F. Cohen
• T. van Donge
• M. Moerland
• J.A.A. Reijers
• F.M.L. Schepers
• J. Stevens
Department of Internal Medicine (Nephrology) and the Eindhoven Laboratory of Experimental Vascular Medicine, Leiden University Medical Center, Leiden, The Netherlands
• M.J.C. Dane
• A.J. van Zonneveld
acknowledgements
affiliations
Janssen Prevention Center, Janssen Vaccines and Prevention b.v., Leiden, The Netherlands
• K.E. Malone
Leiden University Medical Center, Leiden, The Netherlands
• J.W. Jukema(Department of Cardiology)
• R. Verbeek (Department of Clinical Pharmacy and Toxicology)
The Medicines Company
• D.G. Kallend (Zürich, Switzerland)
• P.L.J. Wijngaard (Parsippany, New Jersey, usa)
Alternatives Unit, Biomedical Primate Research Centre, Rijswijk, The Netherlands
• J.J. Bajramovic
