Ustekinumab pharmacokinetics after subcutaneous administration in swine model |
Grabowski, Tomasz
(Polpharma Biologics SA)
Burmanczuk, Artur (Sub-Department of Pharmacology, Toxicology and Environmental Protection, Faculty of Veterinary Medicine, University of Life Sciences) Derlacz, Rafal (Polpharma Biologics SA) Stefaniak, Tadeusz (Department of Immunology, Pathophysiology and Veterinary Preventive Medicine, Wroclaw University of Environmental and Life Sciences) Rzasa, Anna (Department of Immunology, Pathophysiology and Veterinary Preventive Medicine, Wroclaw University of Environmental and Life Sciences) Borkowski, Jacek (Department of Physiology and Biochemistry, University School of Physical Education in Wroclaw) |
1 | Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J. 2014;16(4):658-673. DOI |
2 | Nimmannitya K, Tateishi C, Mizukami Y, Hamamoto K, Yamada S, Goto H, et al. Successful treatment with ustekinumab of psoriasis vulgaris in a patient undergoing hemodialysis. J Dermatol. 2016;43(1):92-94. DOI |
3 | Al Taii H, Yaqoob Z, Al-Kindi SG. Red cell distribution width (RDW) is associated with cardiovascular disease risk in Crohn's disease. Clin Res Hepatol Gastroenterol. 2017;41(4):490-492. DOI |
4 | Tijssen P, Kurstak E. Highly efficient and simple methods for the preparation of peroxidase and active peroxidase-antibody conjugates for enzyme immunoassays. Anal Biochem. 1984;136(2):451-457. DOI |
5 | Gauthier BE, Penard L, Bordier NF, Briffaux JJ, Ruty BM. Specificities of the skin morphology in juvenile minipigs. Toxicol Pathol. 2018;46(7):821-834. DOI |
6 | Ganderup NC, Harvey W, Mortensen JT, Harrouk W. The minipig as nonrodent species in toxicology--where are we now? Int J Toxicol. 2012;31(6):507-528. DOI |
7 | Bittner B, Richter WF, Hourcade-Potelleret F, McIntyre C, Herting F, Zepeda ML, et al. Development of a subcutaneous formulation for trastuzumab - nonclinical and clinical bridging approach to the approved intravenous dosing regimen. Arzneimittelforschung. 2012;62(9):401-409. DOI |
8 | Harvey AJ, Kaestner SA, Sutter DE, Harvey NG, Mikszta JA, Pettis RJ. Microneedle-based intradermal delivery enables rapid lymphatic uptake and distribution of protein drugs. Pharm Res. 2011;28(1):107-116. DOI |
9 | Dalgaard L. Comparison of minipig, dog, monkey and human drug metabolism and disposition. J Pharmacol Toxicol Methods. 2015;74:80-92. DOI |
10 | Ganderup NC. Chapter 3. Minipig models for toxicity testing and biomarkers. In: Gupta RC, editor. Biomarkers in Toxicology. 1st ed. Boston: Academic Press; 2014, 71-91. |
11 | McDonald TA, Zepeda ML, Tomlinson MJ, Bee WH, Ivens IA. Subcutaneous administration of biotherapeutics: current experience in animal models. Curr Opin Mol Ther. 2010;12(4):461-470. |
12 | Burmanczuk A, Milczak A, Grabowski T, Osypiuk M, Kowalski C. The using of a piglets as a model for evaluating the dipyrone hematological effects. BMC Vet Res. 2016;12(1):263. DOI |
13 | Helke KL, Nelson KN, Sargeant AM, Jacob B, McKeag S, Haruna J, et al. Pigs in toxicology: breed differences in metabolism and background findings. Toxicol Pathol. 2016;44(4):575-590. DOI |
14 | Zheng Y, Tesar DB, Benincosa L, Birnbock H, Boswell CA, Bumbaca D, et al. Minipig as a potential translatable model for monoclonal antibody pharmacokinetics after intravenous and subcutaneous administration. MAbs. 2012;4(2):243-255. DOI |
15 | Ryman JT, Meibohm B. Pharmacokinetics of monoclonal antibodies. CPT Pharmacometrics Syst Pharmacol. 2017;6(9):576-588. DOI |
16 | European Medicines Agency (EMA). Annex I. Summary of Product Characteristics. London: European Medicines Agency (EMA); 2018, 1-110. |
17 | U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER). Guidance for Industry: Nonclinical Safety Evaluation of Drug or Biologic Combinations. Rockville: Food and Drug Administration; 2006, 1-16. |
18 | Stec J, Bicka L, Kuzmak J. Isolation and purification of polyclonal IgG antibodies from bovine serum by high performance liquid chromatography. Bull Vet Inst Pulawy. 2004;48(3):321-327. |
19 | Gasowska A, Stefaniak T. Ocena efektow doustnego podania immunoglobuliny zoltka jaja (IgY) cieletom w okresie wchlaniania makromolekul z jelita. Folia Univ Agric Stetin. 2003;233(45):87-92. |
20 | Stirling CM, Charleston B, Takamatsu H, Claypool S, Lencer W, Blumberg RS, et al. Characterization of the porcine neonatal Fc receptor--potential use for trans-epithelial protein delivery. Immunology. 2005;114(4):542-553. DOI |
21 | Gradel AK, Porsgaard T, Lykkesfeldt J, Seested T, Gram-Nielsen S, Kristensen NR, et al. Factors affecting the absorption of subcutaneously administered insulin: effect on variability. J Diabetes Res. 2018;2018:1205121. DOI |
22 | U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER). Guidance for Industry: S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals. Geneva: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH); 2011, 1-23. |
23 | Kagan L, Turner MR, Balu-Iyer SV, Mager DE. Subcutaneous absorption of monoclonal antibodies: role of dose, site of injection, and injection volume on rituximab pharmacokinetics in rats. Pharm Res. 2012;29(2):490-499. DOI |
24 | ter Braak EW, Woodworth JR, Bianchi R, Cerimele B, Erkelens DW, Thijssen JH, et al. Injection site effects on the pharmacokinetics and glucodynamics of insulin lispro and regular insulin. Diabetes Care. 1996;19(12):1437-1440. DOI |
25 | European Medicines Agency (EMA). Assessment Report for STELARA. London: European Medicines Agency (EMA); 2009, 1-58. |
26 | Varkhede N, Forrest ML. Understanding the Monoclonal Antibody Disposition after Subcutaneous Administration using a Minimal Physiologically based Pharmacokinetic Model. J Pharm Pharm Sci. 2018;21(1s):130s-148s. DOI |
27 | Ito R, Suami H. Lymphatic territories (lymphosomes) in swine: an animal model for future lymphatic research. Plast Reconstr Surg. 2015;136(2):297-304. DOI |
28 | Food and Drug Administration. Ustekinumab Label. Rockville: Food and Drug Administration; 2014, 1-25. |
29 | Kota J, Machavaram KK, McLennan DN, Edwards GA, Porter CJ, Charman SA. Lymphatic absorption of subcutaneously administered proteins: influence of different injection sites on the absorption of darbepoetin alfa using a sheep model. Drug Metab Dispos. 2007;35(12):2211-2217. DOI |
30 | Dogan S, Atakan N. Red blood cell distribution width is a reliable marker of inflammation in plaque psoriasis. Acta Dermatovenerol Croat. 2017;25(1):26-31. |
31 | van Mierlo GJ, Cnubben NH, Kuper CF, Wolthoorn J, van Meeteren-Kreikamp AP, Nagtegaal MM, et al. The Gottingen minipig® as an alternative non-rodent species for immunogenicity testing: a demonstrator study using the IL-1 receptor antagonist anakinra. J Immunotoxicol. 2013;10(1):96-105. DOI |
![]() |