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Clinical Pharmacokinetics
Erschienen in: Clinical Pharmacokinetics 1/2015

01.01.2015 | Review Article

Pharmacokinetics and Pharmacokinetic–Pharmacodynamic Relationships of Monoclonal Antibodies in Children

verfasst von: Helena Edlund, Johanna Melin, Zinnia P. Parra-Guillen, Charlotte Kloft

Erschienen in: Clinical Pharmacokinetics | Ausgabe 1/2015

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Abstract

Monoclonal antibodies (mAbs) constitute a therapeutically and economically important drug class with increasing use in both adult and paediatric patients. The rather complex pharmacokinetic and pharmacodynamic properties of mAbs have been extensively reviewed in adults. In children, however, limited information is currently available. This paper aims to comprehensively review published pharmacokinetic and pharmacokinetic–pharmacodynamic studies of mAbs in children. The current status of mAbs in the USA and in Europe is outlined, including a critical discussion of the dosing strategies of approved mAbs. The pharmacokinetic properties of mAbs in children are exhaustively summarised along with comparisons to reports in adults: for each pharmacokinetic process, we discuss the general principles and mechanisms of the pharmacokinetic/pharmacodynamic characteristics of mAbs, as well as key growth and maturational processes in children that might impact these characteristics. Throughout this review, considerable knowledge gaps are identified, especially regarding children-specific properties that influence pharmacokinetics, pharmacodynamics and immunogenicity. Furthermore, the large heterogeneity in the presentation of pharmacokinetic/pharmacodynamic data limited clinical inferences in many aspects of paediatric mAb therapy. Overall, further studies are needed to fully understand the impact of body size and maturational changes on drug exposure and response. To maximise future knowledge gain, we propose a ‘Guideline for Best Practice’ on how to report pharmacokinetic and pharmacokinetic–pharmacodynamic results from mAb studies in children which also facilitates comparisons. Finally, we advocate the use of more sophisticated modelling strategies (population analysis, physiology-based approaches) to appropriately characterise pharmacokinetic–pharmacodynamic relationships of mAbs and, thus, allow for a more rational use of mAb in the paediatric population.
Fußnoten
1
Many other abbreviations are also used in the literature, e.g. HAMA (human anti-murine antibodies), HACA (human anti-chimeric antibodies), HAHA (human anti-human(ised) antibodies); for some mAbs, specific abbreviations have been introduced, e.g. ATI (antibodies towards infliximab).
 
Literatur
1.
2.
Belot A, Cochat P. Les biothérapies en pédiatrie [Biological therapy in pediatrics] [in French]. Arch Pediatr. 2010;17:1573–82.PubMed
3.
Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:633–59.PubMed
4.
Keizer RJ, Huitema ADR, Schellens JHM, Beijen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:493–507.PubMed
5.
Levy G. Pharmacologic target-mediated drug disposition. Clin. Pharmacol Ther. 1994;56:248–52.PubMed
6.
Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008;84:548–58.PubMed
7.
Mould DR, Green B. Pharmacokinetics and pharmacodynamics of monoclonal antibodies: concepts and lessons for drug development. BioDrugs. 2010;24:23–39.PubMed
8.
Tabrizi M, Tseng C, Roskos L. Elimination mechanisms of therapeutic monoclonal antibodies. Drug Discov Today. 2006;11:81–8.PubMed
9.
Lobo ED, Hansen RJ, Balthasar JP. Antibody pharmacokinetics and pharmacodynamics. J Pharm Sci. 2004;93:2645–68.PubMed
10.
Strolin Benedetti M, Whomsley R, Baltes EL. Differences in absorption, distribution, metabolism and excretion of xenobiotics between the paediatric and adult populations. Expert Opin Drug Metab Toxicol. 2005;1:447–71.PubMed
11.
Alcorn J, McNamara PJ. Pharmacokinetics in the newborn. Adv Drug Deliv Rev. 2003;55:667–86.PubMed
12.
13.
14.
15.
Cuzzolin L, Zaccaron A, Fanos V. Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundam Clin Pharmacol. 2003;17:125–31.PubMed
16.
Gillick MR. Controlling off-label medication use. Ann Intern Med. 2009;150:344–7.PubMed
17.
Prytuła A, Iijima K, Kamei K, Geary D, Gottlich E, Majeed A, et al. Rituximab in refractory nephrotic syndrome. Pediatr Nephrol. 2010;25:461–8.PubMed
18.
O’Connor K, Liddle C. Prospective data collection of off-label use of rituximab in Australian public hospitals. Intern Med J. 2013;43:863–70.PubMed
19.
Liang Y, Zhang L, Gao J, Hu D, Ai Y. Rituximab for children with immune thrombocytopenia: a systematic review. PLoS One. 2012;7:e36698.PubMedCentralPubMed
20.
Anink J, Otten MH, Prince FHM, Hoppenreijs EPAH, Wulffraat NM, Swart JF, et al. Tumour necrosis factor-blocking agents in persistent oligoarticular juvenile idiopathic arthritis: results from the Dutch arthritis and biologicals in children register. Rheumatology. 2013;52:712–7.PubMed
21.
Otten MH, Prince FHM, ten Cate R, van Rossum MAJ, Twilt M, Hoppenreijs EPAH, et al. Tumour necrosis factor (TNF)-blocking agents in juvenile psoriatic arthritis: are they effective? Ann Rheum Dis. 2011;70:337–40.PubMed
22.
Speer ME, Fernandes CJ, Boron M, Groothuis JR. Use of palivizumab for prevention of hospitalization as a result of respiratory syncytial virus in infants with cystic fibrosis. Pediatr Infect Dis J. 2008;27:559–61.PubMed
23.
Burns JC, Best BM, Mejias A, Mahony L, Fixler DE, Jafri HS, et al. Infliximab treatment of intravenous immunoglobulin-resistant Kawasaki disease. J Pediatr. 2008;153:833–8.PubMedCentralPubMed
24.
Basu B. Ofatumumab for rituximab-resistant nephrotic syndrome. N Engl J Med. 2014;370:1268–70.PubMed
25.
Steinbrook R. Testing medications in children. N Engl J Med. 2002;347:1462–70.PubMed
26.
27.
28.
Zhang X, Hsu J, Brunner H, De Benedetti F, Le Gallo C, Zuber Z, et al. Pharmacokinetics (PK) and pharmacodynamics (PD) of tocilizumab (TCZ) in polyarticular-course juvenile idiopathic arthritis (pcJIA). Clin Pharmacol Ther. 2013;93(Suppl 1):S88–9.
29.
Johnson TN. The problems in scaling adult drug doses to children. Arch Dis Child. 2008;93:207–11.PubMed
30.
Shi R, Derendorf H. Pediatric dosing and body size in biotherapeutics. Pharmaceutics. 2010;2:389–418.PubMedCentral
31.
Anderson BJ, Holford NHG. Mechanism-based concepts of size and maturity in pharmacokinetics. Annu Rev Pharmacol Toxicol. 2008;48:303–32.PubMed
32.
Anderson BJ, Holford NHG. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab Pharmacokinet. 2009;24:25–36.PubMed
33.
Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987;317:1098.PubMed
34.
Haycock GB, Schwartz GJ, Wisotsky DH. Geometric method for measuring body surface area: a height-weight formula validated in infants, children, and adults. J Pediatr. 1978;93:62–6.PubMed
35.
Du Bois D, Du Bois EF. A formula to estimate the approximate surface area if height and weight be known. Arch Intern Med. 1916;17:863–71.
36.
Dostalek M, Gardner I, Gurbaxani BM, Rose RH, Chetty M. Pharmacokinetics, pharmacodynamics and physiologically-based pharmacokinetic modelling of monoclonal antibodies. Clin Pharmacokinet. 2013;52:83–124.PubMed
37.
Xu Z, Davis HM, Zhou H. Rational development and utilization of antibody-based therapeutic proteins in pediatrics. Pharmacol Ther. 2013;137:225–47.PubMed
38.
Richter WF, Bhansali SG, Morris ME. Mechanistic determinants of biotherapeutics absorption following SC administration. AAPS J. 2012;14:559–70.PubMedCentralPubMed
39.
Kagan L, Mager DE. Mechanisms of subcutaneous absorption of rituximab in rats. Drug Metab Dispos. 2013;41:248–55.PubMed
40.
Kuester K, Kloft C. Pharmacokinetics of monoclonal antibodies (part I and II). In: Meibohm B, editor. Pharmacokinetics and pharmacodynamics of biotech drugs: principles and case studies in drug development. Weinheim: Wiley-VCH Verlag GmbH & Co. KGaA; 2006. p. 45–91.
41.
Lowe PJ, Renard D. Omalizumab decreases IgE production in patients with allergic (IgE-mediated) asthma; PKPD analysis of a biomarker, total IgE. Br J Clin Pharmacol. 2011;72:306–20.PubMedCentralPubMed
42.
Robbie GJ, Zhao L, Mondick J, Losonsky G, Roskos LK. Population pharmacokinetics of palivizumab, a humanized anti-respiratory syncytial virus monoclonal antibody, in adults and children. Antimicrob Agents Chemother. 2012;56:4927–36.PubMedCentralPubMed
43.
Krippendorff B-F, Kuester K, Kloft C, Huisinga W. Nonlinear pharmacokinetics of therapeutic proteins resulting from receptor mediated endocytosis. J Pharmacokinet Pharmacodyn. 2009;36:239–60.PubMedCentralPubMed
44.
Zhang Y, Pardridge WM. Mediated efflux of IgG molecules from brain to blood across the blood-brain barrier. J Neuroimmunol. 2001;114:168–72.PubMed
45.
Butte NF, Hopkinson JM, Wong WW, O’Brian Smith E, Ellis KJ. Body composition during the first 2 years of life: an updated reference. Pediatr Res. 2000;47:578–85.PubMed
46.
Ternant D, Mulleman D, Degenne D, Willot S, Guillaumin J-M, Watier H, et al. An enzyme-linked immunosorbent assay for therapeutic drug monitoring of infliximab. Ther Drug Monit. 2006;28:169–74.PubMed
47.
Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol. 2007;7:715–25.PubMed
48.
Bai S, Jorga K, Xin Y, Jin D, Zheng Y, Damico-Beyer LA, et al. A guide to rational dosing of monoclonal antibodies. Clin Pharmacokinet. 2012;51:119–35.PubMed
49.
Fasanmade A, Adedokun O, Olson A, Strauss R, Davis H. Serum albumin concentration: a predictive factor of infliximab pharmacokinetics and clinical response in patients with ulcerative colitis. Int J Clin Pharmacol. Ther. 2010;48:297–308.PubMed
50.
Fasanmade AA, Adedokun OJ, Blank M, Zhou H, Davis HM. Pharmacokinetic properties of infliximab in children and adults with crohn’s disease: a retrospective analysis of data from 2 phase III clinical trials. Clin Ther. 2011;33:946–64.PubMed
51.
Kapel N, Meillet D, Favennec L, Magne D, Raichvarg D, Gobert JG. Evaluation of intestinal clearance and faecal excretion of alpha 1-antiproteinase and immunoglobulins during Crohn’s disease and ulcerative colitis. Eur J Clin Chem Clin Biochem. 1992;30:197–202.PubMed
52.
Brandse JF, Wildenberg ME, de Bruyn JR, Wolbink G, Lowenberg M, Ponsioen CY, et al. P500 Fecal loss of infliximab as a cause of lack of response in severe inflammatory bowel disease [abstract]. J Crohns Colitis. 2013;7:S210.
53.
Struemper H, Cai W. Population pharmacokinetics of belimumab in systemic lupus erythematosus: insights for monoclonal antibody covariate modeling from a large data set [abstract no. 2792]. PAGE 22; 11–14 Jun 2013; Glasgow. http://​www.​page-meeting.​org/​?​abstract=​2792. Accessed 22 Oct 2014.
54.
Rhodin MM, Anderson BJ, Peters AM, Coulthard MG, Wilkins B, Cole M, et al. Human renal function maturation: a quantitative description using weight and postmenstrual age. Pediatr Nephrol. 2009;24:67–76.PubMed
55.
Holt PG, Jones CA. The development of the immune system during pregnancy and early life. Allergy. 2000;55:688–97.PubMed
56.
Agarwal S, Cunningham-Rundles C. Assessment and clinical interpretation of reduced IgG values. Ann Allergy Asthma Immunol. 2007;99:281–3.PubMedCentralPubMed
57.
Garcia-Lloret M, McGhee S, Chatila T. Immunoglobulin replacement therapy in children. Immunol Allergy Clin N Am. 2008;28:833–49.
58.
Lowe PJ, Tannenbaum S, Gautier A, Jimenez P. Relationship between omalizumab pharmacokinetics, IgE pharmacodynamics and symptoms in patients with severe persistent allergic (IgE-mediated) asthma. Br J Clin Pharmacol. 2009;68:61–76.PubMedCentralPubMed
59.
Goldman J, Davis H, Zhou H, Kearns G. Infliximab clearance in children: potential association with resting energy expenditure. Ann Paediatr Rheum. 2012;1:120–5.
60.
Kovarik JM, Offner G, Broyer M, Niaudet P, Loirat C, Mentser M, et al. A rational dosing algorithm for basiliximab (Simulect) in pediatric renal transplantation based on pharmacokinetic-dynamic evaluations. Transplantation. 2002;74:966–71.PubMed
61.
62.
Mager DE, Jusko WJ. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn. 2001;28:507–32.PubMed
63.
Weisman LE, Thackray HM, Garcia-Prats JA, Nesin M, Schneider JH, Fretz J, et al. Phase 1/2 double-blind, placebo-controlled, dose escalation, safety, and pharmacokinetic study of pagibaximab (BSYX-A110), an antistaphylococcal monoclonal antibody for the prevention of staphylococcal bloodstream infections, in very-low-birth-weight neonates. Antimicrob Agents Chemother. 2009;53:2879–86.PubMedCentralPubMed
64.
Kokai-Kun JF, Mould D, Weisman L, Bloom B, Eyal F, Polack M, et al. Predicted and measured pagibaximab serum levels in high-risk neonates [poster no. 1380]. Pediatr Res. 2010;68:683.
65.
Höcker B, Kovarik JM, Daniel V, Opelz G, Fehrenbach H, Holder M, et al. Pharmacokinetics and immunodynamics of basiliximab in pediatric renal transplant recipients on mycophenolate mofetil comedication. Transplantation. 2008;86:1234–40.PubMed
66.
Nagai T, Gotoh Y, Watarai Y, Tajima T, Arai K, Uchida K. Pharmacokinetics and pharmacodynamics of basiliximab in Japanese pediatric renal transplant patients. Int J Clin Pharmacol Ther. 2010;48:214–23.PubMed
67.
De Groot AS, Scott DW. Immunogenicity of protein therapeutics. Trends Immunol. 2007;28:482–90.PubMed
68.
Schellekens H. Factors influencing the immunogenicity of therapeutic proteins. Nephrol Dial Transplant. 2005;20:vi3–9.PubMed
69.
Niebecker R, Kloft C. Safety of therapeutic monoclonal antibodies. Curr Drug Saf. 2010;5:275–86.PubMed
70.
Chirmule N, Jawa V, Meibohm B. Immunogenicity to therapeutic proteins: impact on PK/PD and efficacy. AAPS J. 2012;14:296–302.PubMedCentralPubMed
71.
72.
Hanauer SB, Wagner CL, Bala M, Mayer L, Travers S, Diamond R, et al. Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn’s disease. Clin Gastroenterol Hepatol. 2004;2:542–53.PubMed
73.
Vincent FB, Morand EF, Murphy K, Mackay F, Mariette X, Marcelli C. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases. Ann Rheum Dis. 2013;72:165–78.PubMed
74.
Wang S-L, Ohrmund L, Hauenstein S, Salbato J, Reddy R, Monk P, et al. Development and validation of a homogeneous mobility shift assay for the measurement of infliximab and antibodies-to-infliximab levels in patient serum. J Immunol Methods. 2012;382:177–88.PubMed
75.
Gómez-Mantilla JD, Trocóniz IF, Parra-Guillén Z, Garrido MJ. Review on modeling anti-antibody responses to monoclonal antibodies. J Pharmacokinet Pharmacodyn. Epub 2014 Jul 16.
76.
Siegrist C-A, Aspinall R. B-cell responses to vaccination at the extremes of age. Nat Rev Immunol. 2009;9:185–94.PubMed
77.
Angiolillo AL, Yu AL, Reaman G, Ingle AM, Secola R, Adamson PC, et al. A phase II study of Campath-1H in children with relapsed or refractory acute lymphoblastic leukemia: a children’s oncology group report. Pediatr Blood Cancer. 2009;53:978–83.PubMedCentralPubMed
78.
Kuemmerle-Deschner JB, Hachulla E, Cartwright R, Haweekins PN, Tran TA, Bader-Meunier B, et al. Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes. Ann Rheum Dis. 2011;70:2095–102.PubMed
79.
Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, Leslie KS, Hachulla E, Quartier P, et al. Use of canakinumab in the cryopyrin-associated periodic syndrome. N Engl J Med. 2009;360:2416–25.PubMed
80.
Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat N, Horneff G, et al. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012;367:2396–406.PubMed
81.
Ruperto N, Quartier P, Wulffraat N, Woo P, Ravelli A, Mouy R, et al. A phase II, multicenter, open-label study evaluating dosing and preliminary safety and efficacy of canakinumab in systemic juvenile idiopathic arthritis with active systemic features. Arthritis Rheum. 2012;64:557–67.PubMed
82.
Baldassano R, Braegger CP, Escher JC, DeWoody K, Hendricks DF, Keenan GF, et al. Infliximab (Remicade) therapy in the treatment of pediatric Crohn’s disease. Am J Gastroenterol. 2003;98:833–8.PubMed
83.
Hadigan C, Baldassano R, Braegger CP, Vasiliauskis E, Escher JC, Sinaasappel M, et al. Pharmacokinetics of infliximab (Anti-TNF) in children with Crohn’s disease: a multicenter trial [abstract]. J Pediatr Gastroenterol Nutr. 1999;29:525.
84.
Abarca K, Jung E, Fernández P, Zhao L, Harris B, Connor EM, et al. Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children. Pediatr Infect Dis J. 2009;28:267–72.PubMed
85.
Weisman LE, Thackray HM, Steinhorn RH, Walsh WF, Lassiter HA, Dhanireddy R, et al. A randomized study of a monoclonal antibody (pagibaximab) to prevent staphylococcal sepsis. Pediatrics. 2011;128:271–9.PubMed
86.
Boeckh M, Berrey MM, Bowden RA, Crawford SW, Balsley J, Corey L. Phase 1 evaluation of the respiratory syncytial virus-specific monoclonal antibody palivizumab in recipients of hematopoietic stem cell transplants. J Infect Dis. 2001;184:350–4.PubMed
87.
Lovell DJ, Ruperto N, Goodman S, Reiff A, Jung L, Jarosova K, et al. Adalimumab with or without methotrexate in juvenile rheumatoid arthritis. N Engl J Med. 2008;359:810–20.PubMed
88.
Imagawa T, Takei S, Umebayashi H, Yamaguchi K, Itoh Y, Kawai T, et al. Efficacy, pharmacokinetics, and safety of adalimumab in pediatric patients with juvenile idiopathic arthritis in Japan. Clin Rheumatol. 2012;31:1713–21.PubMedCentralPubMed
89.
Hyams JS, Griffiths A, Markowitz J, Baldassano RN, Faubion WA, Colletti RB, et al. Safety and efficacy of adalimumab for moderate to severe Crohn’s disease in children. Gastroenterology. 2012;143:365–74.PubMed
90.
Joy MS, Gipson DS, Powell L, MacHardy J, Jennette JC, Vento S, et al. Phase 1 trial of adalimumab in focal segmental glomerulosclerosis (FSGS): II. Report of the FONT (Novel Therapies for Resistant FSGS) study group. Am J Kidney Dis. 2010;55:50–60.PubMedCentralPubMed
91.
Kingsbury DJ, Bader-Meunier B, Patel G, Arora V, Kalabic J, Kupper H. Safety, effectiveness, and pharmacokinetics of adalimumab in children with polyarticular juvenile idiopathic arthritis aged 2–4 years. Clin. Rheumatol. 2014;33:4133–41.
92.
Glade Bender JL, Adamson PC, Reid JM, Xu L, Baruchel S, Shaked Y, et al. Phase I trial and pharmacokinetic study of bevacizumab in pediatric patients with refractory solid tumors: a children’s oncology group study. J Clin Oncol. 2008;26:399–405.PubMed
93.
Trippett TM, Herzog C, Whitlock JA, Wolff J, Kuttesch J, Bagatell R, et al. Phase I and pharmacokinetic study of cetuximab and irinotecan in children with refractory solid tumors: a study of the pediatric oncology experimental therapeutic investigators’ consortium. J Clin Oncol. 2009;27:5102–8.PubMed
94.
Malempati S, Weigel B, Ingle AM, Ahern CH, Carroll JM, Roberts CT, et al. Phase I/II trial and pharmacokinetic study of cixutumumab in pediatric patients with refractory solid tumors and Ewing sarcoma: a report from the Children’s Oncology Group. J Clin Oncol. 2012;30:256–62.PubMedCentralPubMed
95.
Legendre CM, Licht C, Muus P, Greenbaum LA, Babu S, Bedrosian C, et al. Terminal complement inhibitor eculizumab in atypical hemolytic-uremic syndrome. N Engl J Med. 2013;368:2169–81.PubMed
96.
Buckwalter M, Dowell JA, Korth-Bradley J, Gorovits B, Mayer PR. Pharmacokinetics of gemtuzumab ozogamicin as a single-agent treatment of pediatric patients with refractory or relapsed acute myeloid leukemia. J Clin Pharmacol. 2004;44:873–80.PubMed
97.
Candon S, Mosca A, Ruemmele F, Goulet O, Chatenoud L, Cézard J-P. Clinical and biological consequences of immunization to infliximab in pediatric Crohn’s disease. Clin Immunol. 2006;118:11–9.PubMed
98.
Adedokun OJ, Xu Z, Padgett L, Blank M, Johanns J, Griffiths A, et al. Pharmacokinetics of infliximab in children with moderate-to-severe ulcerative colitis: results from a randomized, multicenter, open-label, phase 3 study. Inflamm Bowel Dis. 2013;19:2753–62.PubMed
99.
Hyams J, Crandall W, Kugathasan S, Griffiths A, Olson A, Johanns J, et al. Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn’s disease in children. Gastroenterology. 2007;132:863–73 (quiz 1165–6).PubMed
100.
Hyams J, Walters TD, Crandall W, Kugathasan S, Griffiths A, Blank M, et al. Safety and efficacy of maintenance infliximab therapy for moderate-to-severe Crohn’s disease in children: REACH open-label extension. Curr Med Res Opin. 2011;27:651–62.PubMed
101.
Ruperto N, Lovell DJ, Cuttica R, Wilkinson N, Woo P, Espada G, et al. A randomized, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis. Arthritis Rheum. 2007;56:3096–106.PubMed
102.
Fernández P, Trenholme A, Abarca K, Griffin MP, Hultquist M, Harris B, et al. A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season. BMC Pediatr. 2010;10:38.PubMedCentralPubMed
103.
Grundy J, Pan W, Kugathasan S, Nagpala F, Hilton D, Taylor J, et al. Pharmacokinetics and pharmacodynamics of natalizumab in a phase 2 study of adolescent patients with Crohn’s disease. J Pediatr Gastroenterol Nutr. 2005;41:493–563.
104.
Hyams JS, Wilson DC, Thomas A, Heuschkel R, Mitton S, Mitchell B, et al. Natalizumab therapy for moderate to severe Crohn disease in adolescents. J Pediatr Gastroenterol Nutr. 2007;44:185–91.PubMed
105.
Sáez-Llorens X, Moreno MT, Ramilo O, Sánchez PJ, Top FH, Connor EM. Safety and pharmacokinetics of palivizumab therapy in children hospitalized with respiratory syncytial virus infection. Pediatr Infect Dis J. 2004;23:707–12.PubMed
106.
Sáez-Llorens X, Castaño E, Null D, Steichen J, Sánchez PJ, Ramilo O, et al. Safety and pharmacokinetics of an intramuscular humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. The MEDI-493 Study Group. Pediatr Infect Dis J. 1998;17:787–91.PubMed
107.
Subramanian KN, Weisman LE, Rhodes T, Ariagno R, Sánchez PJ, Steichen J, et al. Safety, tolerance and pharmacokinetics of a humanized monoclonal antibody to respiratory syncytial virus in premature infants and infants with bronchopulmonary dysplasia. MEDI-493 Study Group. Pediatr Infect Dis J. 1998;17:110–5.PubMed
108.
Barth MJ, Goldman S, Smith L, Perkins S, Shiramizu B, Gross TG, et al. Rituximab pharmacokinetics in children and adolescents with de novo intermediate and advanced mature B-cell lymphoma/leukaemia: a children’s oncology group report. Br J Haematol. 2013;162:678–83.PubMedCentralPubMed
109.
Pranzatelli MR, Tate ED, Verhulst SJ, Bertolone SJ, Bhatla D, Granger M, et al. Pediatric dosing of rituximab revisited: serum concentrations in opsoclonus-myoclonus syndrome. J Pediatr Hematol Oncol. 2010;32:e167–72.PubMed
110.
Kamei K, Ito S, Nozu K, Fujinaga S, Nakayama M, Sako M, et al. Single dose of rituximab for refractory steroid-dependent nephrotic syndrome in children. Pediatr Nephrol. 2009;24:1321–8.PubMed
111.
Brunner H, Ruperto N, Zuber Z, Keane C, Harari O, Kenwright A, et al. Efficacy and safety of tocilizumab in patients with polyarticular juvenile idiopathic arthritis: data from a phase 3 trial [abstract no. 1597]. Arthritis Rheum. 2012;64:s682.
112.
Woo P, Wilkinson N, Prieur A-M, Southwood T, Leone V, Livermore P, et al. Open label phase II trial of single, ascending doses of MRA in Caucasian children with severe systemic juvenile idiopathic arthritis: proof of principle of the efficacy of IL-6 receptor blockade in this type of arthritis and demonstration of prolonged clinical improvement. Arthritis Res Ther. 2005;7:R1281–8.PubMedCentralPubMed
113.
Zhang X, Morcos PN, Saito T, Terao K. Clinical pharmacology of tocilizumab for the treatment of systemic juvenile idiopathic arthritis. Expert Rev Clin Pharmacol. 2013;6(2):123–37.PubMed
114.
Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, et al. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008;371:998–1006.PubMed
115.
Zhang X, Morcos PN, De Benedetti F, Brunner H, Ruperto N, Schaefer F, et al. Pharmacokinetics and pharmacodynamics of tocilizumab in systemic juvenile idiopathic arthritis [abstract]. Pharmacotherapy. 2011;31(10):381e.
116.
Kakkar T, Sung C, Gibiansky L, Vu T, Narayanan A, Lin S-L, et al. Population PK and IgE pharmacodynamic analysis of a fully human monoclonal antibody against IL4 receptor. Pharm Res. 2011;28:2530–42.PubMed
117.
Turner DC, Navid F, Daw NC, Mao S, Wu J, Santana VM, et al. Population pharmacokinetics of bevacizumab in children with osteosarcoma: implications for dosing. Clin Cancer Res. 2014;20:2783–92.PubMed
118.
Pescovitz MD, Knechtle S, Alexander SR, Colombani P, Nevins T, Nieforth K, et al. Safety and pharmacokinetics of daclizumab in pediatric renal transplant recipients. Pediatr Transplant. 2008;12:447–55.PubMed
119.
Xu Z, Mould D, Hu C, Ford J, Keen M, Davis HM, et al. Population pharmacokinetic analysis of infliximab in pediatrics using integrated data from six clinical trials. Clin Pharmacol Drug Dev. 2012;4:203.
120.
Zhao L, Roskos L, Griffin P, Losonsky G, Jallal GB, Robbie G. 891 Population pharmacokinetics analysis of motavizumab in children at risk for respiratory syncytial virus infection. Pediatr. Res. 2010;68:447.
121.
Marian M, Sun Y-N, Sinclair D, Kenkare S, Sallas W, Mortensen D, et al. PI-23 Clincal pharmacokinetics (PK) and IgE pharmacodynamics (PD) of omalizumab, a recombinant humanized monoclonal antibody to IgE. Clin Pharmacol Ther. 2001;69:P7.
122.
Bennett CM, Rogers ZR, Kinnamon DD, Bussel JB, Mahoney DH, Abshire TC, et al. Prospective phase 1/2 study of rituximab in childhood and adolescent chronic immune thrombocytopenic purpura. Blood. 2006;107:2639–42.PubMedCentralPubMed
123.
Hagopian W, Ferry RJ, Sherry N, Carlin D, Bonvini E, Johnson S, et al. Teplizumab preserves C-Peptide in recent-onset type 1 diabetes. Two-year results from the randomized, placebo-controlled Protégé trial. Diabetes. 2013;62:3901–8.PubMedCentralPubMed
124.
Sherry N, Hagopian W, Ludvigsson J, Jain SM, Wahlen J, Ferry RJ, et al. Teplizumab for treatment of type 1 diabetes (Protégé study): 1-year results from a randomised, placebo-controlled trial. Lancet. 2011;378:487–97.PubMedCentralPubMed
Metadaten
Titel
Pharmacokinetics and Pharmacokinetic–Pharmacodynamic Relationships of Monoclonal Antibodies in Children
verfasst von
Helena Edlund
Johanna Melin
Zinnia P. Parra-Guillen
Charlotte Kloft
Publikationsdatum
01.01.2015
Verlag
Springer International Publishing
Erschienen in
Clinical Pharmacokinetics / Ausgabe 1/2015
Print ISSN: 0312-5963
Elektronische ISSN: 1179-1926
DOI
https://doi.org/10.1007/s40262-014-0208-4

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