109
Views
4
CrossRef citations to date
0
Altmetric
Review

Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility

, , , &
Pages 155-167 | Published online: 16 Apr 2014

References

  • KDOQI Clinical Practice Guidelines: KDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease [webpage on the Internet]New YorkNational Kidney Foundation2006 Available from: http://www.kidney.org/professionals/kdoqi/guidelines_anemia/cpr12.htmAccessed September 09, 2013
  • KDOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification, and StratificationNew YorkNational Kidney Foundation2002 Available from: http://www.kidney.org/professionals/kdoqi/guidelines_ckd/bibliography.htm#267Accessed September 09, 2013
  • Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work GroupKDIGO Clinical Practice Guideline for Anemia in Chronic Kidney DiseaseKidney Int20122279335
  • CoreshJSelvinEStevensLAPrevalence of chronic kidney disease in the United StatesJAMA2007298172038204717986697
  • El NahasAMBelloAKChronic kidney disease: the global challengeLancet2005365945633134015664230
  • US GovernmentRenal Data System, USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of HealthNational Institute of Diabetes and Digestive and Kidney DiseasesBethesda, MD2013
  • RoderickPRothMMindellJPrevalence of chronic kidney disease in England: findings from the 2009 health survey for EnglandJ Epidemiol Community Health201165Suppl IA12
  • ZoccaliCKramerAJagerKChronic kidney disease and end-stage renal disease a review produced to contribute to the report ‘status of health in the European union: towards a healthier Europe’NDT Plus201033213224
  • MurrayCJVosTLozanoRDisability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990–2010; a systematic analysis for the Global Burden of Disease Study 2010Lancet201238098592197222323245608
  • LevinAIdentification of patients and risk factors in chronic kidney disease: evaluating risk factors and therapeutic strategiesNephrol Dial Transplant200116Suppl 7576011590259
  • ChadbanSHowellMTwiggSCARIThe CARI guidelines. Cost-effectiveness and socioeconomic implications of prevention and management of chronic kidney disease in type 2 diabetesNephrology (Carlton)201015Suppl 1S19520320591031
  • GoASChertowGMFanDMcCullochCEHsuCYChronic kidney disease and the risks of death, cardiovascular events, and hospitalizationsN Engl J Med2004351131296130515385656
  • WeinerDETighiouartHAminMGChronic kidney disease as a risk factor for cardiovascular disease and all-cause mortality: A pooled analysis of community-based studiesJ Am Soc Nephrol20041551307131515100371
  • RoncoCHaapioMHouseAAAnavekarNBellomoRCardiorenal syndromeJ Am Coll Cardol2008521915271539
  • AstorBCMuntnerPLevinAEustaceJACoreshJAssociation of kidney function with aneamia; The Third national Health and Nutrition Examination Survey (1988–1994)Arch Intern Med2002162121401140812076240
  • McClellanWAronoffSLBoltonWKThe prevalence of anemia in patients with chronic kidney diseaseCurr Med Res Opin20042091501151015383200
  • PainterPMooreGCarlsonLEffects of exercise training plus normalization of hematocrit on exercise capacity and health-related quality of lifeAm J Kidney Dis200239225726511840365
  • PerlmanRLFinkelsteinFOLiuLQuality of life in chronic kidney disease (CKD); a cross-sectional analysis in the Renal Research Institute-CKD studyAm J Kidney Dis200545465866615806468
  • BaigentCBurburyKWheelerDPremature cardiovascular disease in chronic renal failureLancet2000356922414715210963260
  • PortolésJGorrizJLRubioEfor NADIR-3 Study GroupThe development of anemia is associated to poor prognosis in NKF/KDOQI stage 3 chronic kidney diseaseBMC Nephrol201314223295149
  • ThorpMLJohnsonESYangXPetrikAFPlattRSmithDHEffect of anaemia on mortality, cardiovascular hospitalization and end-stage renal disease among patients with chronic kidney diseaseNephrology (Carlton)200914224024619207866
  • LocatelliFAndrulliSMemoliBNutritional-inflammation status and resistance to erythropoietin therapy in haemodialysis patientsNephrol Dial Transplant200621499199816384825
  • VaziriNDAnemia and anemia correction: surrogate markers or causes of morbidity in chronic kidney disease?Nat Clin Pract Nephrol20084843644518542121
  • WizemannVRutkowskiBBaldamusCScigallaPKoytchevREpoetin Zeta Study GroupComparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatmentCurr Med Res Opin200824362563718208642
  • EandiMErythropoiesis-stimulating agents in patients with chronic kidney diseaseRev Health Care201232113125
  • McGonigleRJWallinJDShadduckRKFisherJWErythropoietin deficiency and inhibition of erythropoiesis in renal insufficiencyKidney Int19842524374446727139
  • LonnemannGMacdougallICBiosimilar epoetins in renal anaemia â current status and insights from European practiceEur Nephrol201152101107
  • KrivoshievSTodorovVVManitiusJComparison of the therapeutic effects of epoetin zeta and epoetin alfa in the correction of renal anaemiaCurr Med Res Opin20082451407141518394266
  • MacdougallICRecent advances in erythropoietic agents in renal aneamiaSemin Nephrol200626431331816949470
  • LocatelliFBáránayPCovicAKidney Disease: Improving Global Outcomes guidelines on anaemia management in chronic kidney disease: a European Renal Best Practice position statementNephrol Dial Transplant20132861346135923585588
  • KDOQIKDOQI Clinical Practice Guidelines and Clinical Practice Recommendations for Diabetes and Chronic Kidney DiseaseAm J Kidney Dis2007492 Suppl 2S12S15417276798
  • Zumbreanen-BulloghKBabittJLThe iron cycle in CKD: from genetics and experimental models to CKD patientsNephrol Dial Transplant Epub11132013
  • JonesMSchenkelBJustJEpoetin alfa’s effect on left ventricular hypertrophy and subsequent mortalityInt J Cardiol2005100225326515823633
  • BenzRLPressmanMRHovickETPetersonDDA preliminary study of the effects of correction of anemia with recombinant human erythropoietin therapy on sleep, sleep disorders, and daytime sleepiness in hemodialysis patients (the SLEEPO study)Am J Kidney Dis19993461089109510585319
  • EvansRWRecombinant human erythropoietin and the quality of life of end-stage renal disease patients: a comparative analysisAm J Kidney Dis1991184 Suppl 162701928082
  • PainterPThe importance of exercise training in rehabilitation of patients with end-stage renal diseaseAm J Kidney Dis1994241 Suppl 1S2S9 discussion S31–S328023835
  • RevickiDABrownREFeenyDHHealth-related quality of life associated with recombinant human erythropoietin therapy for predialysis chronic renal disease patientsAm J Kidney Dis19952545485547702049
  • RogerSDBiosimilars: How similar or dissimilar are they?Nephrology (Carlton)200611434134616889575
  • Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietins (Revision)LondonEuropean Medicines Agency, Committee for Medicinal Products for Human Use (CHMP)201010 [about 8 p.] Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089474.pdfAccessed September 12, 2013
  • RossertJEMEA guidelines on biosimilars and their clinical implicationsKidney Blood Press Res200730Suppl 1131717726338
  • KrivoshievSWizemannVCzekalskSTherapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemiaAdv Ther201027210511720369312
  • TrioloGItalian Society of NephrologyGuidelines for the treatment of aneamia in chronic renal failureG Ital Nefrol200320Suppl 24S61S82 Italian14666504
  • BarosiGBosiAAbbroacchioMPKey concepts and crucial issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow TransplantationHaematologica201196793794221719882
  • WallerCFBiosimilars and their use in hematology and oncologyCommun Oncol201296198205
  • TsiftsoglouASRuizSSchneiderCKDevelopment and regulation of biosimilars: Current status and future challengesBio Drugs2013273203211
  • BorgesLDifferent modalities of erythropoiesis stimulating agentsPort J Nephrol Hypert2010242137145
  • SitteHHBiologicals and biosimilarsPort J Nephrol Hypert2009232135139
  • TamilvananSRajaNLSaBBasuSKClinical concerns of immunogenicity produced at cellular levels by biopharmaceuticals following heir parenteral administration into human bodyJ Drug Target2010181748949820192653
  • SchellekensHBiosimilar therapeutics – what do we need to consider?NDT Plus20092Suppl 1i27i3619461855
  • CasadevallNEchardtKURossertJEpoetin-induced autoimmune pure red cell aplasiaJ Am Soc Nephrol200516Suppl 1S67S6915938038
  • CasadevallNWhat is antibody-mediated pure red cell aplasia (PRCA)?Nephrol Dial Transplant200520Suppl 4iv3iv815827056
  • AbrahamISunDBagalagelABiosimilars in 3D: Definition, development and differentiationBioengineered20134420320623714845
  • AhmedIKasparBSharmaUBiosimilars: Impact of biologic product life cycle and European experience on the regulatory trajectory in the United StatesClin Ther201234240041922244050
  • CombeCTredreeRLSchellekensHBiosimilar epoetins: An analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteinsPharmacother2005257954962
  • WeiseMBielskyMCDe SmetKBiosimilars: what clinicians should knowBlood2012120265111511723093622
  • Non-clinical guidelines: European Union guidelines adopted in Australia [webpage on the Internet]Symonston: Department of HealthTherapeutic Goods Administration2012 Available from: http://www.tga.gov.au/industry/pm-euguidelines-adopted-nonclinical.htm#nonclinicalsimilarAccessed Sept 10, 2013
  • Del VecchioLLocatelliFSafety issues related to erythropoiesis-stimulating agents used to treat anemia in patients with chronic kidney diseaseExpert Opin Drug Saf201211692393122916722
  • European Medicines Agency: Committee for Medicinal Products for Human Use (CHMP)Guidelines on Immunogenicity Assessment of Biotechnology-Derived Therapeutic ProteinsLondonEuropean Medicines Agency2007 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003947.pdfAccessed September 09, 2013
  • European Medicines Agency: Committee for Medicinal Products for Human Use (CHMP)Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issuesLondonEuropean Medicines Agency2006 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdfAccessed September 09, 2013
  • JelkmannWBiosimilar epoetins and other “follow-on” biologics: update on the European experiencesAm J Hematol2010851077178020706990
  • European medicines AgencyScientific discussionLondonEuropean medicines Agency2007 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000872/WC500054374.pdfAccessed September 10, 2013
  • MP389 Immunogenicity of epoetin zeta in the treatment of renal anaemia [webpage on the internet]CasadevallNKrommingaAScigallaP Available from: http://www.abstracts2view.com/era_archive/view.php?nu=ERA08L_1714Accessed September 14, 2013
  • Guidance for industry formal meetings between the FDA and biosimilar biological product sponsors or applicants [webpage on the Internet]Silver SpringU.S. Food and Drug Administration Available from: http://www.fda.gov/Drugs/GuidancecomplianceRegulatoryInformation/Guidances/default.htmAccessed March 2013
  • 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)Draft guidance for industry formal meetings between FDA and biosimilars biological product sponsors or applicants Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM345649.pdfAccessed January 8, 2014
  • Decision memo for erythropoiesis stimulating agents (ESAs) for treatment of anemia in adults with CKD including patients on dialysis and patients not on dialysis (CAG-00413N) [webpage on the Internet]BaltimoreCenters for Medicare and Medicaid Services (CMS)2011 Available from: http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=245&bc=AAAAAAAACAAAAA%3d%3d&Accessed September 20, 2013
  • Erythropoietin stimulating agents policies [webpage on the Internet]BaltimoreCenters for Medicare and Medicaid Services (CMS)2013 Available from: http://www.cms.gov/Medicare/Coverage/CoverageGenInfo/esapolicies.htmlAccessed September 20, 2013
  • KapitsinouPPLiuQUngerTLHepatic HIF-2 regulates erythropoietic responses to hypoxia in renal anemiaBlood2010116163039304820628150
  • MacdougallICNovel agents for anaemia management in chronic kidney diseaseEuropiean Nephrol2010413741
  • HaaseVHRegulation of erythropoiesis by hypoxia-inducible factorsBlood Rev2013271415323291219
  • BernhardtWMWiesenerMSScigallaPInhibition of prolyl hydroxylases increases erythropoietin production in ESRDJ Am Soc Nephrol201021122151215621115615
  • EschbachJWEgrieJCDowningMRBrowneJKAdamsonJWCorrection of the anemia of end-stage renal disease with recombinant human erythropoietinN Engl J Med1987316273783537801
  • AdamsonJWEschbachJWManagement of the anaemia of chronic renal failure with recombinant erythropoietinQ J Med198973272109311012694210
  • HörlWHDifferentiating factors between erythropoiesis-stimulating agents: An update to selection for anaemia of Chronic Kidney DiseaseDrugs201373211713023338536
  • WalshGPost-translational modifications in the context of therapeutic proteins: An introductory overviewPost-translational Modification of Protein BiopharmaceuticalsWest Sussex, UKWiley-Blackwell2009114
  • LocatelliFDel VecchioLErythropoiesis-stimulating agents in renal medicineOncologist201116Suppl 3192421930831
  • LonnemannGWrengerEBiosimilar epoetin zeta in nephrology: Effect of injection frequency on weekly doseInt J Clin Med20123598602
  • EbbersHCMuenzbergMSchellekensHThe safety of switching between therapeutic proteinsExpert Opin Biol Ther201212111473148522849511
  • CasadevallNEdwardsIRFelixTPharmacovigilance and biosimilars: Considerations, needs and challengesExpert Opinion Biol Ther201313710391047
  • BaldamusCKrivoshievSWolf-PflugmannMSiebert-WeigelMKoytchevRBronnALong-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemiaAdv Ther200825111215122818931828
  • BachmakovIMeiBnerRBenkensteinCSa423 Comparison of long-term efficacy and safety of epoetin zeta in elderly ‘real-word’ patients with chronic kidney disease (CKD) and renal anaemia on dialysis aged ≥ and <75 yearsPoster Session: Anaemia in CKD 5
  • BajraktarJLazarovaBNajdovskaEMihajlovaLDSL-011 efficacy and safety of epoetin zeta in dialysis patientsEur J Hosp Pharm Sci Pract201320A91
  • SinghASaczechLTangKLCorrection of anemia with epoetin alfa in chronic kidney diseaseNew Engl J Med2006355202085209817108343
  • DrüekeTBLocatelliFClyneNfor the CREATE investigatorsNormalization of hemoglobin level in patients with chronic kidney disease and anemiaN Engl J Med2006355202071208417108342
  • PfefferMABurdmannEAChenCA trial of darbepoetin alfa in type 2 diabetes and chronic kidney diseaseN Engl J Med2009361212019203219880844
  • ZockaliCAbramowiczDCannata-AndiaJBEuropean best practice quo vadis? From European best practice guidelines (EBPG) to European renal best practice (ERBP)Nephrol Dial Transplant2008232162216618469309
  • PollockCJohnsonDWHörlWHPure red cell aplasia induced by erythropoiesis-stimulating agentsClin J Am Soc Nephrol20083119319918178785
  • PeraniLScolariCBrausAGalliEGRP-179 switch from CERA to EPO zeta in patients with anaemia and chronic kidney diseaseEur J Hos Pharm Sci Pract201320A64
  • WiecekAAhmedIScigallaPKoytchevRSwitching epoetin alfa and epoetin zeta in patients with renal anemia on dialysis: Posthoc analysisAdv Ther2010271294195220972656
  • AbrahamIMacDonaldKClinical safety of biosimilar recombinant human erythropoietinsExpert Opin Drug Saf201211581984022880621
  • Retacrit: epetin zeta. Product information: Annex I Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000872/human_med_001031.jsp&mid=WC0b01ac058001d124Accessed March 4, 2014
  • LeeJSHaTKLeeSJLeeGMCurrent state and perspectives on erythropoietin productionAppl Microbiol Biotechnol20129561405141622820523
  • LeeJFLittenJBGramppGComparability and biosimilarity: Considerations for the healthcare providerCurr Med Res Opin20122861053105822519391
  • SalemLHarvieBBiosimilar medicines and their use: The nurse’s role and responsibilityRen Soc Aust J2010627680
  • GoldsmithDGesualdoLBiosimilar epoetins in nephrology – where are we nowEur Nephrol201262124
  • SimoensSVerbekenGHuysIBiosimilars and market access: A question of comparability and costs?Targeted Oncol201274227231
  • GoldsmithD2009: A requiem for rHuEPOs – but should we nail down the coffin in 2010?Clin J Am Soc Nephrol20105592993520413441
  • LopezMJAntoninoGVicenteIMejiaLGarciaPSanchezAErythropoietic factors in renal chronic disease: Economic managementInt J Clin Pharm2012341221222
  • PearsonIVJohnsonKIA cost minimization analysis of epoetin zeta for the treatment of anemia associated with chronic kidney diseaseValue Health2008113A304
  • SimoensSBiosimilar medicines and cost-effectivenessClinicoecon Outcomes Res20113293621935330
  • TzekovaVMihaylovGElezovicIKoytchevREpoetin Zeta Oncology Study GroupTherapeutic effects of epoetin zeta in the treatment of chemotherapy-induced anaemia. Curr Med Res OpinJul200925716891697
  • SoniRKWeisbordSDUnruhMLHealth-related quality of life outcomes in chronic kidney diseaseCurr Opin Nephrol Hypertens201019215315920051850
  • LefebvrePVekemanFSarokhanBEnnyCProvenzanoRCremieuxPYRelationship between hemoglobin level and quality of life in anemic patients with chronic kidney disease receiving epoetin alfaCurr Med Res Opin200622101929193717022852
  • KeownPAChurchillDNPoulin-CostelloMDialysis patients treated with epoetin alfa show improved anemia symptoms; A new analysis of the Canadian Erythropoietin Study Group trialHemodial Int201014216817320345390
  • JonesMIbelsLSchenkelBZagariMImpact of epoetin alfa on clinical end points in patients with chronic renal failure: a meta-analysisKidney Int200465375776714871396
  • KimelMLeidyNKMannixSDixonJDoes epoetin alfa improve health-related quality of life in chronically ill patients with anemia? Summary of trials of cancer, HIV/AIDS, and chronic kidney diseaseValue Health2008111577518237361
  • LeafDEGoldfarbDSInterpretation and review of health-related quality of life data in CKD patients receiving treatment for anemiaKidney Int20089751152418813284
  • All Wales Medicines Strategy Group [homepage on the Internet]Epoetin zeta (Retacrit®): Reference 130 final appraisal recommendation Available from: http://www.awmsg.org/awmsgonline/app/appraisalinfo/130Accessed March 6, 2014