Peginesatide for the treatment of renal disease-induced anemia

Bibliography

• Coresh J, Selvin E, Stevens LA, Prevalence of chronic kidney disease in the United States. JAMA 2007;298(17):2038-47
   PubMed Web of Science ®Google Scholar
• Eaves AC, Eaves CY. Erythropoiesis in culture. Clin Haematol 1984;13:371
   PubMedGoogle Scholar
• Wickrema A, Bondurant MC, Krantz SB. Abundance and stability of erythropoietin receptor mRNA in mouse erythroid progenitor cells. Blood 1991;78(9):2269-75
   PubMed Web of Science ®Google Scholar
• Goldsmith D. 2009: a requiem for rHuEPOs–but should we nail down the coffin in 2010? Clin J Am Soc Nephrol 2010;5(5):929-35
   PubMed Web of Science ®Google Scholar
• Besarab A, Bolton WK, Browne JK, The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin. N Engl J Med 1998;339(9):584-90
   PubMed Web of Science ®Google Scholar
• Singh AK, Szczech L, Tang KL, Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006;355(20):2085-98
   PubMed Web of Science ®Google Scholar
• Drueke TB, Locatelli F, Clyne N, Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006;355(20):2071-84
   PubMed Web of Science ®Google Scholar
• Pfeffer MA, Burdmann EA, Chen CY, A trial of darbepoetin alfa in Type 2 diabetes and chronic kidney disease. N Engl J Med 2009;361(21):2019-32
   PubMed Web of Science ®Google Scholar
• Locatelli F, Del Vecchio L. An expert opinion on the current treatment of anemia in patients with kidney disease. Expert Opin Pharmacother 2012;13(4):495-503
   PubMed Web of Science ®Google Scholar
• Kidney Disease: improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Inter Suppl 2012;2:279-335
   Web of Science ®Google Scholar
• Fishbane S, Jhaveri KD. The new label for erythropoiesis stimulating agents: the FDA'S sentence. Semin Dial 2012;25(3):263-6
   PubMed Web of Science ®Google Scholar
• Jelkmann W. Biosimilar epoetins and other "follow-on" biologics: update on the European experiences. Am J Hematol 2010;85(10):771-80
   PubMed Web of Science ®Google Scholar
• Fisch P, Handgretinger R, Schaefer HE. Pure red cell aplasia. Br J Haematol 2000;111(4):1010-22
   PubMed Web of Science ®Google Scholar
• Gross AW, Lodish HF. Cellular trafficking and degradation of erythropoietin and novel erythropoiesis stimulating protein (NESP). J Biol Chem 2006;281(4):2024-32
   PubMed Web of Science ®Google Scholar
• Brunkhorst R, Bommer J, Braun J, Darbepoetin alfa effectively maintains haemoglobin concentrations at extended dose intervals relative to intravenous or subcutaneous recombinant human erythropoietin in dialysis patients. Nephrol Dial Transplant 2004;19(5):1224-30
   PubMed Web of Science ®Google Scholar
• Suranyi MG, Lindberg JS, Navarro J, Treatment of anemia with darbepoetin alfa administered de novo once every other week in chronic kidney disease. Am J Nephrol 2003;23(2):106-11
   PubMed Web of Science ®Google Scholar
• Schmidt RJ. Methoxy polyethylene glycol-epoetin beta: worth waiting for or a novelty worn off? Expert Opin Pharmacother 2009;10(9):1509-14
   PubMed Web of Science ®Google Scholar
• Levin NW, Fishbane S, Canedo FV, Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet 2007;370(9596):1415-21
   PubMed Web of Science ®Google Scholar
• Macdougall IC, Walker R, Provenzano R, C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial. Clin J Am Soc Nephrol 2008;3(2):337-47
   PubMed Web of Science ®Google Scholar
• Wrighton NC, Farrell FX, Chang R, Small peptides as potent mimetics of the protein hormone erythropoietin. Science 1996;273(5274):458-64
   PubMed Web of Science ®Google Scholar
• Johnson DL, Jolliffe LK. Erythropoietin mimetic peptides and the future. Nephrol Dial Transplant 2000;15:1274
   PubMed Web of Science ®Google Scholar
• Bouman-Thio E, Franson K, Miller B, A Phase I, single and fractionated, ascending-dose study evaluating the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of an erythropoietin mimetic antibody fusion protein (CNTO 528) in healthy male subjects. J Clin Pharmacol 2008;48(10):1197-207
   PubMed Web of Science ®Google Scholar
• Sathyanarayana P, Houde E, Marshall D, CNTO 530 functions as a potent EPO mimetic via unique sustained effects on bone marrow proerythroblast pools. Blood 2009;113(20):4955-62
   PubMed Web of Science ®Google Scholar
• Fan Q, Leuther KK, Holmes CP, Preclinical evaluation of Hematide, a novel erythropoiesis stimulating agent, for the treatment of anemia. Exp Hematol 2006;34(10):1303-11
   PubMed Web of Science ®Google Scholar
• Green JM, Leu K, Schatz PJ, Wojchowski D. Peginesatide stimulation allows for a longer lifespan of the activated erythropoietin receptor [abstract]. J Am Soc Nephrol 2011;22:674A
   Google Scholar
• Verma R, Green JM, Leu K. Candidate action mechanisms of peginesatide-induced erythropoiesis [abstract]. J Am Soc Nephrol 2012;23:135A
   Google Scholar
• Woodburn KW, Schatz PJ, Fong KL, Preclinical safety and pharmacology of Hematide, a peptidic erythropoiesis stimulating agent (ESA), in rats and monkeys. Drug Chem Toxicol 2008;31(2):229-44
   PubMed Web of Science ®Google Scholar
• Woodburn KW, Schatz PJ, Fong KL, Beaumier P. Erythropoiesis equivalence, pharmacokinetics and immune response following repeat hematide administration in cynomolgus monkeys. Int J Immunopathol Pharmacol 2010;23(1):121-9
   PubMed Web of Science ®Google Scholar
• Stead RB, Lambert J, Wessels D, Evaluation of the safety and pharmacodynamics of Hematide, a novel erythropoietic agent, in a Phase 1, double-blind, placebo-controlled, dose-escalation study in healthy volunteers. Blood 2006;108(6):1830-4
   PubMed Web of Science ®Google Scholar
• Green JM, Leu K, Worth A, Peginesatide and erythropoietin stimulate similar erythropoietin receptor-mediated signal transduction and gene induction events. Exp Hematol 2012;40(7):575-87
   PubMed Web of Science ®Google Scholar
• Im S, Fong KL, Nishihara M, Hematide™/Peginesatide is metabolically stable and does not induce or inhibit human cytochrome P450 [abstract]. J Am Soc Nephrol 2010;21:704A
   Google Scholar
• Woodburn KW, Holmes CP, Wilson SD, Absorption, distribution, metabolism and excretion of peginesatide, a novel erythropoiesis-stimulating agent, in rats. Xenobiotica 2012;42(7):660-70
   PubMed Web of Science ®Google Scholar
• Czerniak R, Kukulka MJ, Naik H, Pharmacokinetics (PK): pharmacodynamics (PD) of peginesatide in patients with chronic kidney disease on dialysis [abstract]. J Am Soc Nephrol 2012;23:560A
   Google Scholar
• Macdougall IC, Rossert J, Casadevall N, A peptide-based erythropoietin-receptor agonist for pure red-cell aplasia. N Engl J Med 2009;361(19):1848-55
   PubMed Web of Science ®Google Scholar
• Macdougall IC, Wiecek A, Tucker B, Dose-finding study of peginesatide for anemia correction in chronic kidney disease patients. Clin J Am Soc Nephrol 2011;6(11):2579-86
   PubMed Web of Science ®Google Scholar
• Besarab A, Zeig SN, Martin ER, An open-label, sequential, dose-finding study of peginesatide for the maintenance treatment of anemia in chronic hemodialysis patients. BMC Nephrol 2012;13:95
   PubMed Web of Science ®Google Scholar
• Fishbane S, Roger SD, Martin E, Peginesatide for maintenance treatment of anemia in hemodialysis and nondialysis patients previously treated with darbepoetin alfa. Clin J Am Soc Nephrol 2012; Epub ahead of print
   Web of Science ®Google Scholar
• Fishbane S, Schiller B, Locatelli F, Peginesatide in patients with anemia undergoing hemodialysis. N Engl J Med 2013;368(4):307-19
   PubMed Web of Science ®Google Scholar
• Macdougall IC, Provenzano R, Sharma A, Peginesatide for anemia in patients with chronic kidney disease not receiving dialysis. N Engl J Med 2013;368(4):320-32
   PubMed Web of Science ®Google Scholar
• Woodburn KW, Fan Q, Winslow S, Hematide is immunologically distinct from erythropoietin and corrects anemia induced by antierythropoietin antibodies in a rat pure red cell aplasia model. Exp Hematol 2007;35(8):1201-8
   PubMed Web of Science ®Google Scholar
• Schiller B, Schmidt RJ, Rastogi A, Initial dose stability after conversion to peginesatide in HD patients [abstract]. J Am Soc Nephrol 2012;22:429A
   Google Scholar
• Provenzano R, Schiller B, Kaplan M, Hemoglobin (Hb) stability during peginesatide versus Epoetin treatment in Hemodialysis (HD) patients [abstract]. J Am Soc Nephrol 2011;22:486A
   Google Scholar
• Besarab A, Locatelli F, Fishbane S, Rate of Hemoglobin (Hb) decline following peginesatide dose interruption [abstract]. J Am Soc Nephrol 2011;22:477A
   Google Scholar
• Spinowitz BS, Zeig S, Tang H, Hemoglobin control and dose alterations with peginesatide versus epoetin for hemodialysis patients [abstract]. J Am Soc Nephrol 2012;23:429A
   PubMedGoogle Scholar
• Schiller B, MacDougall IC, Locatelli F, IV versus SC ESA dosing requirements in US and Non-US Hemodialysis (HD) patients [abstract]. J Am Soc Nephrol 2011;22:485A
   Web of Science ®Google Scholar
• Locatelli F, Besarab A, Sharma A, Relationship between Baseline Inflammatory Status and Cardiovascular (CV) Events in Hemodialysis (HD) Patients (Pts) on Peginesatide or Epoetin [Abstract]. J Am Soc Nephrol 2012;23:784A
   Google Scholar
• Drueke TB. Anemia treatment in patients with chronic kidney disease. N Engl J Med 2013;368(4):387-9
   PubMed Web of Science ®Google Scholar
• Schatz PJ, Fan Q, Chen MJ, Hematide™ is minimally immunogenic in nonclinical studies [abstract]. J Am Soc Nephrol 2009;20:668A
   Google Scholar
• Woodburn KW, Schatz PJ, Wilson S, Genotoxic assessment and toxicity evaluation of peginesatide in CByB6F1 hybrid mice. Drug Chem Toxicol 2011;34(3):240-9
   PubMed Web of Science ®Google Scholar
• Woodburn KW, Wilson SD, Fong KL, Chronic preclinical safety evaluation of Hematide, a pegylated peptidic erythropoiesis stimulating agent in monkeys. Haematologica 2008;93(9):1376-9
   PubMed Web of Science ®Google Scholar
• Schatz PJ, Tong S, Mathur VS, Peginesatide immunogenicity in clinical studies of CKD patients [abstract]. J Am Soc Nephrol 2012;23:429A
   PubMedGoogle Scholar
• Woodburn KW, Wilson SD, Fong KL, Chronic pharmacological and safety evaluation of Hematide, a PEGylated peptidic erythropoiesis-stimulating agent, in rodents. Basic Clin Pharmacol Toxicol 2009;104(2):155-63
   PubMed Web of Science ®Google Scholar
• Lewis EM, Hoberman AM, Fong KL, Peri- and postnatal rodent development of Hematide, an erythropoiesis-stimulating agent. Birth Defects Res B Dev Reprod Toxicol 2010;89(2):155-63
   PubMedGoogle Scholar
• Affymax and Takeda Announce Permanent J-Code for OMONTYS® (peginesatide). Available from: http://www.investors.affymax.com/releasedetail.cfm?ReleaseID=731272 [Last accessed 9 January 2013]
   Google Scholar
• Freburger JK, Ng LJ, Bradbury BD, Changing patterns of anemia management in US hemodialysis patients. Am J Med 2012;125(9):906-14
   PubMed Web of Science ®Google Scholar
• Macdougall IC. New anemia therapies: translating novel strategies from bench to bedside. Am J Kidney Dis 2012;59:444
   PubMed Web of Science ®Google Scholar
• Del Vecchio L, Cavalli A, Tucci B, Locatelli F. Chronic kidney disease-associated anemia: new remedies. Curr Opin Investig Drugs 2010;11(9):1030-8
   PubMedGoogle Scholar
• Schiller B, Doss S, DE Cock E, Costs of managing anemia with erythropoiesis-stimulating agents during hemodialysis: a time and motion study. Hemodial Int 2008;12(4):441-9
   PubMed Web of Science ®Google Scholar
• Mikhail A. Profile of peginesatide and its potential for the treatment of anemia in adults with chronic kidney disease who are on dialysis. J Blood Med 2012;3:25-31
   PubMedGoogle Scholar
• Doss S, Schiller B. Peginesatide: a potential erythropoiesis stimulating agent for the treatment of anemia of chronic renal failure. Nephrol Nurs J 2010;37(6):617-26
   PubMed Web of Science ®Google Scholar
• Macdougall IC, Roger SD, de Francisco A, Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights. Kidney Int 2012;81(8):727-32
   PubMed Web of Science ®Google Scholar
• Provenzano R, Spinowitz BS, Besarab A, Intravenous (IV) IRON USE in US Hemodialysis (HD) Patients (Pts) Receiving Peginesatide for Anemia due to Chronic Kidney Disease [Abstract]. J Am Soc Nephrol 2012;23:22A
   PubMedGoogle Scholar
• Why did shares of Affymax jump today? By Max Macaluso. Available from: www.dailyfinance.com/2012/10/09/-3/ [Last accessed 3 January 2013]
   Google Scholar
• Canaud B, Mingardi G, Braun J, Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized Phase III study. Nephrol Dial Transplant 2008;23(11):3654-61
   PubMed Web of Science ®Google Scholar
• Macdougall IC, Walker R, Provenzano R, C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial. Clin J Am Soc Nephrol 2008;3(2):337-47
   PubMed Web of Science ®Google Scholar