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Pharmacokinetic modeling of therapies for systemic lupus erythematosus

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References

  • Pawar RD, Patole PS, Ellwart A, et al. Ligands to nucleic acid-specific toll-like receptors and the onset of lupus nephritis. J Am Soc Nephrol 2006;17(12):3365-73
  • Pascual V, Banchereau J, Palucka AK. The central role of dendritic cells and interferon-alpha in SLE. Curr Opin Rheumatol 2003;15(5):548-56
  • Hochberg MC. Updating the American College of Rheumatology revised criteria for the classification of systemic lupus erythematosus. Arthritis Rheum 1997;40(9):1725
  • van Hasselt JG, Andrew MA, Hebert MF, et al. The status of pharmacometrics in pregnancy: highlights from the 3(rd) American conference on pharmacometrics. Br J Clin Pharmacol 2012;74(6):932-9
  • Gillespie WR. Noncompartmental versus compartmental modelling in clinical pharmacokinetics. Clin Pharmacokinet 1991;20(4):253-62
  • Jang GR, Harris RZ, Lau DT. Pharmacokinetics and its role in small molecule drug discovery research. Med Res Rev 2001;21(5):382-96
  • Sheiner L, Wakefield J. Population modelling in drug development. Stat Methods Med Res 1999;8(3):183-93
  • Neely M, Jelliffe R. Practical, individualized dosing: 21st century therapeutics and the clinical pharmacometrician. J Clin Pharmacol 2010;50(7):842-7
  • Neely M, Jelliffe R. Practical therapeutic drug management in HIV-infected patients: use of population pharmacokinetic models supplemented by individualized Bayesian dose optimization. J Clin Pharmacol 2008;48(9):1081-91
  • Tsamandouras N, Rostami-Hodjegan A, Aarons L. Combining the ’bottom up’ and ’top down’ approaches in pharmacokinetic modelling: fitting PBPK models to observed clinical data. Br J Clin Pharmacol 2015;79(1):48-55
  • Chen P, Vu T, Narayanan A, et al. Pharmacokinetic and pharmacodynamic relationship of AMG 811, an anti-IFN-gamma IgG1 monoclonal antibody, in patients with systemic lupus erythematosus. Pharm Res 2015;32(2):640-53
  • Kremer JM. Toward a better understanding of methotrexate. Arthritis Rheum 2004;50(5):1370-82
  • Wong JM, Esdaile JM. Methotrexate in systemic lupus erythematosus. Lupus 2005;14(2):101-5
  • Sakthiswary R, Suresh E. Methotrexate in systemic lupus erythematosus: a systematic review of its efficacy. Lupus 2014;23(3):225-35
  • Fortin PR, Abrahamowicz M, Ferland D, et al. Steroid-sparing effects of methotrexate in systemic lupus erythematosus: a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2008;59(12):1796-804
  • Sato EI. Methotrexate therapy in systemic lupus erythematosus. Lupus 2001;10(3):162-4
  • Winzer M, Aringer M. Use of methotrexate in patients with systemic lupus erythematosus and primary Sjogren’s syndrome. Clin Exp Rheumatol 2010;28:S156-9
  • Carneiro JR, Sato EI. Double blind, randomized, placebo controlled clinical trial of methotrexate in systemic lupus erythematosus. J Rheumatol 1999;26(6):1275-9
  • Drugs C. Trexall 2000-2015. [cited 6 April 2015] Available from: http://www.drugs.com/pro/trexall.html
  • Dervieux T, Furst D, Lein DO, et al. Polyglutamation of methotrexate with common polymorphisms in reduced folate carrier, aminoimidazole carboxamide ribonucleotide transformylase, and thymidylate synthase are associated with methotrexate effects in rheumatoid arthritis. Arthritis Rheum 2004;50(9):2766-74
  • Dervieux T, Furst D, Lein DO, et al. Pharmacogenetic and metabolite measurements are associated with clinical status in patients with rheumatoid arthritis treated with methotrexate: results of a multicentred cross sectional observational study. Ann Rheum Dis 2005;64(8):1180-5
  • Dervieux T, Greenstein N, Kremer J. Pharmacogenomic and metabolic biomarkers in the folate pathway and their association with methotrexate effects during dosage escalation in rheumatoid arthritis. Arthritis Rheum 2006;54(10):3095-103
  • Poulin P, Chen YH, Ding X, et al. Prediction of drug distribution in subcutaneous xenografts of human tumor cell lines and healthy tissues in mouse: application of the tissue composition-based model to antineoplastic drugs. J Pharm Sci 2015;104(4):1508-21
  • Abu-Shakra M, Shoenfeld Y. Azathioprine therapy for patients with systemic lupus erythematosus. Lupus 2001;10(3):152-3
  • Patel AA, Swerlick RA, McCall CO. Azathioprine in dermatology: the past, the present, and the future. J Am Acad Dermatol 2006;55(3):369-89
  • Van Os EC, Zins BJ, Sandborn WJ, et al. Azathioprine pharmacokinetics after intravenous, oral, delayed release oral and rectal foam administration. Gut 1996;39(1):63-8
  • Food and Drug Administration Center for Drug Evaluation and Research. Summary minutes of the pediatric oncology subcommittee of the oncologic drugs advisory committee. 2003. Available from: http://www.fda.gov/ohrms/dockets/ac/03/minutes/3971M1.pdf [Cited 6 April 2015]
  • ARUP Laboratories. Thiopurine Methyltransferase, RBC. 2015. Available from: http://ltd.aruplab.com/Tests/Pub/0092066 [Cited 4 April 2015]
  • Dubinsky MC, Lamothe S, Yang HY, et al. Pharmacogenomics and metabolite measurement for 6-mercaptopurine therapy in inflammatory bowel disease. Gastroenterology 2000;118(4):705-13
  • ARUP Laboratories. Thiopurine Drug Metabolites. 2015. Available from: http://ltd.aruplab.com/Tests/Pub/2011134 [Cited 4 April 2015]
  • Askanase AD, Wallace DJ, Weisman MH, et al. Use of pharmacogenetics, enzymatic phenotyping, and metabolite monitoring to guide treatment with azathioprine in patients with systemic lupus erythematosus. J Rheumatol 2009;36(1):89-95
  • Kawasaki Y. Mizoribine: a new approach in the treatment of renal disease. Clin Dev Immunol 2009;2009:681482
  • Yokota S. Mizoribine: mode of action and effects in clinical use. Pediatr Int 2002;44(2):196-8
  • Feng X, Gu F, Chen W, et al. Mizoribine versus mycophenolate mofetil or intravenous cyclophosphamide for induction treatment of active lupus nephritis. Chin Med J (Engl) 2014;127(21):3718-23
  • Stypinski D, Obaidi M, Combs M, et al. Safety, tolerability and pharmacokinetics of higher-dose mizoribine in healthy male volunteers. Br J Clin Pharmacol 2007;63(4):459-68
  • Honda M, Itoh H, Suzuki T, et al. Population pharmacokinetics of higher-dose mizoribine in healthy male volunteers. Biol Pharm Bull 2006;29(12):2460-4
  • Yoshidome K, Takei S, Imanaka H, et al. Efficacy of mizoribine in the treatment of systemic lupus erythematosus in children. Pediatr Int 2004;46(4):444-9
  • Nozu K, Iijima K, Kamioka I, et al. High-dose mizoribine treatment for adolescents with systemic lupus erythematosus. Pediatr Int 2006;48(2):152-7
  • Foran JM, Oscier D, Orchard J, et al. Pharmacokinetic study of single doses of oral fludarabine phosphate in patients with “low-grade” non-Hodgkin’s lymphoma and B-cell chronic lymphocytic leukemia. J Clin Oncol 1999;17(5):1574-9
  • Illei GG, Klippel JH. Novel approaches in the treatment of lupus nephritis. Lupus 1998;7(9):644-8
  • Hood MA, Finley RS. Fludarabine: a review. DICP 1991;25(5):518-24
  • Kuo GM, Boumpas DT, Illei GG, et al. Fludarabine pharmacokinetics after subcutaneous and intravenous administration in patients with lupus nephritis. Pharmacotherapy 2001;21(5):528-33
  • Sherwin CM, Fukuda T, Brunner HI, et al. The evolution of population pharmacokinetic models to describe the enterohepatic recycling of mycophenolic acid in solid organ transplantation and autoimmune disease. Clin Pharmacokinet 2011;50(1):1-24
  • Tang Q, Yang Y, Zhao M, et al. Mycophenolic acid upregulates miR-142-3P/5P and miR-146a in lupus CD4+T cells. Lupus 2015
  • Bullingham RE, Nicholls A, Hale M. Pharmacokinetics of mycophenolate mofetil (RS61443): a short review. Transplant Proc 1996;28(2):925-9
  • de Winter BC, Neumann I, van Hest RM, et al. Limited sampling strategies for therapeutic drug monitoring of mycophenolate mofetil therapy in patients with autoimmune disease. Ther Drug Monit 2009;31(3):382-90
  • Jiao Z, Ding JJ, Shen J, et al. Population pharmacokinetic modelling for enterohepatic circulation of mycophenolic acid in healthy Chinese and the influence of polymorphisms in UGT1A9. Br J Clin Pharmacol 2008;65(6):893-907
  • Sherwin CM, Sagcal-Gironella AC, Fukuda T, et al. Development of population PK model with enterohepatic circulation for mycophenolic acid in patients with childhood-onset systemic lupus erythematosus. Br J Clin Pharmacol 2012;73:727-40
  • Zahr N, Amoura Z, Debord J, et al. Pharmacokinetic study of mycophenolate mofetil in patients with systemic lupus erythematosus and design of Bayesian estimator using limited sampling strategies. Clin Pharmacokinet 2008;47(4):277-84
  • Woillard JB, Bader-Meunier B, Salomon R, et al. Pharmacokinetics of mycophenolate mofetil in children with lupus and clinical findings in favour of therapeutic drug monitoring. Br J Clin Pharmacol 2014;78:867-76
  • Filler G, Hansen M, LeBlanc C, et al. Pharmacokinetics of mycophenolate mofetil for autoimmune disease in children. Pediatr Nephrol 2003;18(5):445-9
  • Neumann I, Fuhrmann H, Fang IF, et al. Association between mycophenolic acid 12-h trough levels and clinical endpoints in patients with autoimmune disease on mycophenolate mofetil. Nephrol Dial Transplant 2008;23(11):3514-20
  • Mino Y, Naito T, Matsushita T, et al. Comparison of pharmacokinetics of mycophenolic acid and its glucuronide between patients with lupus nephritis and with kidney transplantation. Ther Drug Monit 2008;30(6):656-61
  • Joy MS, Hilliard T, Hu Y, et al. Pharmacokinetics of mycophenolic acid in patients with lupus nephritis. Pharmacotherapy 2009;29(1):7-16
  • Lertdumrongluk P, Somparn P, Kittanamongkolchai W, et al. Pharmacokinetics of mycophenolic acid in severe lupus nephritis. Kidney Int 2010;78(4):389-95
  • Djabarouti S, Breilh D, Duffau P, et al. Steady-state mycophenolate mofetil pharmacokinetic parameters enable prediction of systemic lupus erythematosus clinical flares: an observational cohort study. Arthritis Res Ther 2010;12(6):R217
  • Joy MS, Boyette T, Hu Y, et al. Effects of uridine diphosphate glucuronosyltransferase 2B7 and 1A7 pharmacogenomics and patient clinical parameters on steady-state mycophenolic acid pharmacokinetics in glomerulonephritis. Eur J Clin Pharmacol 2010;66(11):1119-30
  • Mino Y, Naito T, Shimoyama K, et al. Pharmacokinetic variability of mycophenolic acid and its glucuronide in systemic lupus erythematosus patients in remission maintenance phase. Biol Pharm Bull 2011;34(5):755-9
  • Fukuda T, Brunner HI, Sagcal-Gironella AC, et al. Nonsteroidal anti-inflammatory drugs may reduce enterohepatic recirculation of mycophenolic acid in patients with childhood-onset systemic lupus erythematosus. Ther Drug Monit 2011;33(5):658-62
  • Sagcal-Gironella AC, Fukuda T, Wiers K, et al. Pharmacokinetics and pharmacodynamics of mycophenolic acid and their relation to response to therapy of childhood-onset systemic lupus erythematosus. Semin Arthritis Rheum 2011;40(4):307-13
  • Streicher C, Djabarouti S, Xuereb F, et al. Pre-dose plasma concentration monitoring of mycophenolate mofetil in patients with autoimmune diseases. Br J Clin Pharmacol 2014;78(6):1419-25
  • Kittanamongkolchai W, Rukrung C, Supasiri T, et al. Therapeutic drug monitoring of mycophenolate mofetil for the treatment of severely active lupus nephritis. Lupus 2013;22(7):727-32
  • Zahr N, Arnaud L, Marquet P, et al. Mycophenolic acid area under the curve correlates with disease activity in lupus patients treated with mycophenolate mofetil. Arthritis Rheum 2010;62(7):2047-54
  • Yau WP, Vathsala A, Lou HX, et al. Mechanism-based enterohepatic circulation model of mycophenolic acid and its glucuronide metabolite: assessment of impact of cyclosporine dose in Asian renal transplant patients. J Clin Pharmacol 2009;49(6):684-99
  • Malmborg J, Ploeger BA. Predicting human exposure of active drug after oral prodrug administration, using a joined in vitro/in silico-in vivo extrapolation and physiologically-based pharmacokinetic modeling approach. J Pharmacol Toxicol Methods 2013;67(3):203-13
  • Esdaile JM. How to manage patients with lupus nephritis. Best Pract Res Clin Rheumatol 2002;16(2):195-210
  • Austin HAIII, Klippel JH, Balow JE(et al):Therapy of lupus nephritis. Controlled trial of prednisone and cytotoxic drugs. N Engl J Med 1986;314(10):614-19
  • Jang SY, Dooley MA, Joy MS. Impact of severe hypothyroidism on cyclophosphamide disposition and routes of metabolism and transport in a patient with treatment-resistant lupus nephritis. Ann Pharmacother 2013;47(7-8):e35
  • Robak E, Robak T. Novel and emerging drugs for systemic lupus erythematosus: mechanism of action and therapeutic activity. Curr Med Chem 2012;19(3):438-53
  • De Bruijn EA, Slee PH, Van Oosterom AT, et al. Pharmacokinetics of intravenous and oral cyclophosphamide in the presence of methotrexate and fluorouracil. Pharm Weekbl Sci 1988;10(5):200-6
  • Juma FD, Rogers HJ, Trounce JR. Pharmacokinetics of cyclophosphamide and alkylating activity in man after intravenous and oral administration. Br J Clin Pharmacol 1979;8(3):209-17
  • Busse D, Busch FW, Bohnenstengel F, et al. Dose escalation of cyclophosphamide in patients with breast cancer: consequences for pharmacokinetics and metabolism. J Clin Oncol 1997;15(5):1885-96
  • Drugs.com. Cyclophosphamide 2000-2015. Available from: http://www.drugs.com/ppa/cyclophosphamide.html [Cited 4 April 2015]
  • Food and Drug Administration. Cyclophosphamide for Injection. 2012. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/012141s089lbl.pdf [Cited 5 April 2015]
  • Haubitz M, Bohnenstengel F, Brunkhorst R, et al. Cyclophosphamide pharmacokinetics and dose requirements in patients with renal insufficiency. Kidney Int 2002;61(4):1495-501
  • Juma FD, Rogers HJ, Trounce JR. Effect of renal insufficiency on the pharmacokinetics of cyclophosphamide and some of its metabolites. Eur J Clin Pharmacol 1981;19(6):443-51
  • Tam LS, Li EK, Leung CB, et al. Long-term treatment of lupus nephritis with cyclosporin A. QJM 1998;91(8):573-80
  • Favre H, Miescher PA, Huang YP, et al. Ciclosporin in the treatment of lupus nephritis. Am J Nephrol 1989;9(Suppl 1):57-60
  • Fu LW, Yang LY, Chen WP, et al. Clinical efficacy of cyclosporin a neoral in the treatment of paediatric lupus nephritis with heavy proteinuria. Br J Rheumatol 1998;37(2):217-21
  • Zavada J, Pesickova S, Rysava R, et al. Cyclosporine A or intravenous cyclophosphamide for lupus nephritis: the Cyclofa-Lune study. Lupus 2010;19:1281-9
  • Austin HAIII, Illei GG, Braun MJ(et al):Randomized, controlled trial of prednisone, cyclophosphamide, and cyclosporine in lupus membranous nephropathy. J Am Soc Nephrol 2009;20(4):901-11
  • Hallegua D, Wallace DJ, Metzger AL, et al. Cyclosporine for lupus membranous nephritis: experience with ten patients and review of the literature. Lupus 2000;9(4):241-51
  • Manger K, Kalden JR, Manger B. Cyclosporin A in the treatment of systemic lupus erythematosus: results of an open clinical study. Br J Rheumatol 1996;35(7):669-75
  • Moroni G, Doria A, Ponticelli C. Cyclosporine (CsA) in lupus nephritis: assessing the evidence. Nephrol Dial Transplant 2009;24(1):15-20
  • Cattaneo D, Perico N, Gaspari F, et al. Nephrotoxic aspects of cyclosporine. Transplant Proc 2004;36:234S-9S
  • Awni WM. Pharmacodynamic monitoring of cyclosporin. Clin Pharmacokinet 1992;23(6):428-48
  • Isenberg DA, Snaith ML, Morrow WJ, et al. Cyclosporin A for the treatment of systemic lupus erythematosus. Int J Immunopharmacol 1981;3(2):163-9
  • Tokuda M, Kurata N, Mizoguchi A, et al. Effect of low-dose cyclosporin A on systemic lupus erythematosus disease activity. Arthritis Rheum 1994;37(4):551-8
  • Germano V, Picchianti Diamanti A, Ferlito C, et al. Cyclosporine A in the long-term management of systemic lupus erythematosus. J Biol Regul Homeost Agents 2011;25(3):397-403
  • Caccavo D, Lagana B, Mitterhofer AP, et al. Long-term treatment of systemic lupus erythematosus with cyclosporin A. Arthritis Rheum 1997;40(1):27-35
  • Dammacco F, Della Casa Alberighi O, Ferraccioli G, et al. Cyclosporine-A plus steroids versus steroids alone in the 12-month treatment of systemic lupus erythematosus. Int J Clin Lab Res 2000;30(2):67-73
  • Lindholm A. Factors influencing the pharmacokinetics of cyclosporine in man. Ther Drug Monit 1991;13(6):465-77
  • Fahr A. Cyclosporin clinical pharmacokinetics. Clin Pharmacokinet 1993;24(6):472-95
  • Suchy D, Dostalek M, Perinova I, et al. Single-dose and steady state pharmacokinetics of CSA and two main primary metabolites, AM1 and AM4n in patients with rheumatic/autoimmune diseases. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub 2011;155(3):269-74
  • Vrana A, Andrysek T. The effect of particle size on bioavailability in cyclosporine preparations based on submicron dispersions. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub 2001;145(2):9-15
  • Fu LW, Yang LY, Chen WP, et al. Cyclosporin pharmacokinetics following administration of capsules and Neoral in paediatric patients with lupus nephritis. Br J Clin Pharmacol 1997;44(2):125-7
  • Bayry J, Negi VS, Kaveri SV. Intravenous immunoglobulin therapy in rheumatic diseases. Nat Rev Rheumatol 2011;7(6):349-59
  • Rutter A, Luger TA. High-dose intravenous immunoglobulins: an approach to treat severe immune-mediated and autoimmune diseases of the skin. J Am Acad Dermatol 2001;44(6):1010-24
  • Hundt M, Manger K, Dorner T, et al. Treatment of acute exacerbation of systemic lupus erythematosus with high-dose intravenous immunoglobulin. Rheumatology (Oxford) 2000;39(11):1301-2
  • Winder A, Molad Y, Ostfeld I, et al. Treatment of systemic lupus erythematosus by prolonged administration of high dose intravenous immunoglobulin: report of 2 cases. J Rheumatol 1993;20(3):495-8
  • Corvetta A, Della Bitta R, Gabrielli A, et al. Use of high-dose intravenous immunoglobulin in systemic lupus erythematosus: report of three cases. Clin Exp Rheumatol 1989;7(3):295-9
  • Orbach H, Tishler M, Shoenfeld Y. Intravenous immunoglobulin and the kidney–a two-edged sword. Semin Arthritis Rheum 2004;34(3):593-601
  • Bonilla FA. Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes. Immunol Allergy Clin North Am 2008;28(4):803-19; ix
  • Andresen I, Kovarik JM, Spycher M, et al. Product equivalence study comparing the tolerability, pharmacokinetics, and pharmacodynamics of various human immunoglobulin-G formulations. J Clin Pharmacol 2000;40(7):722-30
  • Ensom MH, Stephenson MD. A two-center study on the pharmacokinetics of intravenous immunoglobulin before and during pregnancy in healthy women with poor obstetrical histories. Hum Reprod 2011;26(9):2283-8
  • Chirico G, Rondini G, Plebani A, et al. Intravenous gammaglobulin therapy for prophylaxis of infection in high-risk neonates. J Pediatr 1987;110(3):437-42
  • Stabile A, Miceli Sopo S, Romanelli V, et al. Intravenous immunoglobulin for prophylaxis of neonatal sepsis in premature infants. Arch Dis Child 1988;63:3.441-3
  • Sidiropoulos D, Boehme U, Von Muralt G, et al. Immunoglobulin supplementation in prevention or treatment of neonatal sepsis. Pediatr Infect Dis 1986;5:S193-4
  • Noya FJ, Rench MA, Garcia-Prats JA, et al. Disposition of an immunoglobulin intravenous preparation in very low birth weight neonates. J Pediatr 1988;112(2):278-83
  • Noya FJ, Rench MA, Courtney JT, et al. Pharmacokinetics of intravenous immunoglobulin in very low birth weight neonates. Pediatr Infect Dis J 1989;8(11):759-63
  • Kinney J, Mundorf L, Gleason C, et al. Efficacy and pharmacokinetics of intravenous immune globulin administration to high-risk neonates. Am J Dis Child 1991;145(11):1233-8
  • Kyllonen KS, Clapp DW, Kliegman RM, et al. Dosage of intravenously administered immune globulin and dosing interval required to maintain target levels of immunoglobulin G in low birth weight infants. J Pediatr 1989;115:1013-16
  • Barrett JS, Mondick JT, Narayan M, et al. Integration of modeling and simulation into hospital-based decision support systems guiding pediatric pharmacotherapy. BMC Med Inform Decis Mak 2008;8:6
  • Mould DR, Dubinsky MC. Dashboard systems: Pharmacokinetic/pharmacodynamic mediated dose optimization for monoclonal antibodies. J Clin Pharmacol 2015;55(Suppl 3):S51-9
  • Mould DR, Upton RN, Wojciechowski J. Dashboard systems: implementing pharmacometrics from bench to bedside. AAPS J 2014;16:925-37

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