메뉴 건너뛰기




Volumn 7, Issue 3, 2017, Pages

Comparative effectiveness and safety of erythropoiesis-stimulating agents (biosimilars vs originators) in clinical practice: A population-based cohort study in Italy

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; RECOMBINANT ERYTHROPOIETIN; ANTIANEMIC AGENT;

EID: 85015227757     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2016-011637     Document Type: Article
Times cited : (27)

References (35)
  • 1
    • 85015152515 scopus 로고    scopus 로고
    • Associazione Italiana di Oncologia Medica. Milan
    • Associazione Italiana di Oncologia Medica. Linee Guida Gestione della tossicità ematopoietica in oncologia. Milan, 2015: 50p. http://www.aiom.it/professionisti/documenti-scientifici/linee-guida/tossicit-ematopoietica/1,710,1
    • (2015) Linee Guida Gestione Della Tossicità Ematopoietica in Oncologia , pp. 50
  • 2
    • 84884333035 scopus 로고    scopus 로고
    • KDIGO clinical practice guideline for anemia in chronic kidney disease
    • Improving Global Outcomes (KDIGO) Anemia Work Group
    • Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Int Suppl 2012;2: 279-335.
    • (2012) Kidney Int Suppl , vol.2 , pp. 279-335
    • Disease, K.1
  • 3
    • 84875173075 scopus 로고    scopus 로고
    • Sistema Nazionale Linee Guida -Istituto Superiore di Sanità Società Italiana di Nefrologia Ministero della Salute Rome
    • Sistema Nazionale Linee Guida -Istituto Superiore di Sanità, Società Italiana di Nefrologia, Ministero della Salute. Linea Guida "Identificazione, prevenzione e gestione della Malattia Renale Cronica nell'adulto". Rome, 2012: 136p. http://www.snlg-iss.it/lgn-malattia-renale
    • (2012) Linea Guida "Identificazione prevenzione e gestione della Malattia Renale Cronica nell'adulto" , pp. 136
  • 4
    • 49249083689 scopus 로고    scopus 로고
    • September 2007 update on EORTC guidelines and anemia management with erythropoiesis-stimulating agents
    • Aapro MS, Link H. September 2007 update on EORTC guidelines and anemia management with erythropoiesis-stimulating agents. Oncologist 2008;13(Suppl 3): S33-6.
    • (2008) Oncologist , vol.13 , pp. S33-326
    • Aapro, M.S.1    Link, H.2
  • 5
    • 78651434523 scopus 로고    scopus 로고
    • American Society of Clinical Oncology, American Society of Hematology. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer
    • Rizzo JD, Brouwers M, Hurley P, et al. American Society of Clinical Oncology, American Society of Hematology. American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update on the use of epoetin and darbepoetin in adult patients with cancer. J Clin Oncol 2010;28: 4996-5010.
    • (2010) J Clin Oncol , vol.28 , pp. 4996-5010
    • Rizzo, J.D.1    Brouwers, M.2    Hurley, P.3
  • 6
    • 85015167372 scopus 로고    scopus 로고
    • National Comprehensive Cancer Network (NCCN). USA, Available from
    • National Comprehensive Cancer Network (NCCN). NCCN guidelines. Cancer-and chemotherapy-induced anemia (version 2.2016). USA, 2015: 50p. Available from: Http://www.nccn.org/professionals/physician-gls/f-guidelines.asp
    • (2015) NCCN Guidelines. Cancer-and Chemotherapy-Induced Anemia (Version 2. 2016) , pp. 50
  • 7
    • 0032795554 scopus 로고    scopus 로고
    • Trends in use, cost, and outcomes of human recombinant erythropoietin, 1989-98
    • Greer JW, Milam RA, Eggers PW. Trends in use, cost, and outcomes of human recombinant erythropoietin, 1989-98. Health Care Financ Rev 1999;20: 55-62.
    • (1999) Health Care Financ Rev , vol.20 , pp. 55-62
    • Greer, J.W.1    Milam, R.A.2    Eggers, P.W.3
  • 8
    • 0001564209 scopus 로고    scopus 로고
    • European survey on anaemia management (ESAM)
    • European Survey on Anaemia Management (ESAM). Nephrol Dial Transplant 2000;15(Suppl 4): S1-76.
    • (2000) Nephrol Dial Transplant , vol.15 , pp. S1-76
  • 9
    • 0008348082 scopus 로고    scopus 로고
    • Open database. London: The European Medicines Agency. (cited January 5).
    • Open database. European public assessment reports. London: The European Medicines Agency. (cited 2016 January 5). http://www. ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar-search.jsp&mid=WC0b01ac058001d124.
    • (2016) European Public Assessment Reports
  • 10
    • 84904023507 scopus 로고    scopus 로고
    • Barriers to the uptake of biosimilars and possible solutions: A Belgian case study
    • Dylst P, Vulto A, Simoens S. Barriers to the uptake of biosimilars and possible solutions: A Belgian case study. Pharmacoeconomics 2014;32: 681-91.
    • (2014) Pharmacoeconomics , vol.32 , pp. 681-691
    • Dylst, P.1    Vulto, A.2    Simoens, S.3
  • 11
    • 84930902956 scopus 로고    scopus 로고
    • Demonstrating value for biosimilars: A conceptual framework
    • Rompas S, Goss T, Amanuel S, et al. Demonstrating value for biosimilars: A conceptual framework. Am Health Drug Benefits 2015;8: 129-39.
    • (2015) Am Health Drug Benefits , vol.8 , pp. 129-139
    • Rompas, S.1    Goss, T.2    Amanuel, S.3
  • 12
    • 85015211470 scopus 로고    scopus 로고
    • Italian Medicines Agency. National Report on Medicines use in Italy. Year Rome, 2015
    • Italian Medicines Agency. The Medicines Utilisation Monitoring Centre (OsMed). National Report on Medicines use in Italy. Year 2014. Rome, 2015: 522. http://www.agenziafarmaco.gov.it/it/content/rapporti-osmed-luso-dei-farmaci-italia
    • (2014) The Medicines Utilisation Monitoring Centre (OsMed) , pp. 522
  • 13
    • 84941346467 scopus 로고    scopus 로고
    • How much are biosimilars used in clinical practice? A retrospective Italian population-based study of erythropoiesis-stimulating agents in the years 2009-2013
    • Ingrasciotta Y, Giorgianni F, Bolcato J, et al. How much are biosimilars used in clinical practice? A retrospective Italian population-based study of erythropoiesis-stimulating agents in the years 2009-2013. BioDrugs 2015;29: 275-84.
    • (2015) BioDrugs , vol.29 , pp. 275-284
    • Ingrasciotta, Y.1    Giorgianni, F.2    Bolcato, J.3
  • 14
    • 84925223869 scopus 로고    scopus 로고
    • Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: A network meta-analysis
    • Palmer SC, Saglimbene V, Mavridis D, et al. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: A network meta-analysis. Cochrane Database Syst Rev 2014;(12): CD010590.
    • (2014) Cochrane Database Syst Rev , vol.12 , pp. CD010590
    • Palmer, S.C.1    Saglimbene, V.2    Mavridis, D.3
  • 15
    • 79959992578 scopus 로고    scopus 로고
    • Key concepts and critical 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 Transplantation
    • Barosi G, Bosi A, Abbracchio MP, et al. Key concepts and critical 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 Transplantation. Haematologica 2011;96: 937-42.
    • (2011) Haematologica , vol.96 , pp. 937-942
    • Barosi, G.1    Bosi, A.2    Abbracchio, M.P.3
  • 16
    • 85008448747 scopus 로고    scopus 로고
    • Erythropoiesis-stimulating agents for the treatment of chemotherapy-induced anemia: Comparisons from real-world clinical experience
    • Rodriguez Garzotto A, Cortijo Casacajares S, Pernaut C, et al. Erythropoiesis-stimulating agents for the treatment of chemotherapy-induced anemia: Comparisons from real-world clinical experience. J Blood Med 2014;5: 43-8.
    • (2014) J Blood Med , vol.5 , pp. 43-48
    • Rodriguez Garzotto, A.1    Cortijo Casacajares, S.2    Pernaut, C.3
  • 17
    • 84905369715 scopus 로고    scopus 로고
    • BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: Results of the ORHEO observational study
    • Michallet M, Luporsi E, Soubeyran P, et al. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: Results of the ORHEO observational study. BMC Cancer 2014;14: 503.
    • (2014) BMC Cancer , vol.14 , pp. 503
    • Michallet, M.1    Luporsi, E.2    Soubeyran, P.3
  • 18
    • 84942693123 scopus 로고    scopus 로고
    • Biosimilar epoetin zeta in oncology and haematology: Development and experience following 6 years of use
    • Michallet M, Losem C. Biosimilar epoetin zeta in oncology and haematology: Development and experience following 6 years of use. Acta Haematol 2016;135: 44-52.
    • (2016) Acta Haematol , vol.135 , pp. 44-52
    • Michallet, M.1    Losem, C.2
  • 20
    • 79952768939 scopus 로고    scopus 로고
    • Today's challenges in pharmacovigilance: What can we learn from epoetins?
    • Ebbers HC, Mantel-Teeuwisse AK, Moors EH, et al. Today's challenges in pharmacovigilance: What can we learn from epoetins? Drug Saf 2011;34: 273-87.
    • (2011) Drug Saf , vol.34 , pp. 273-287
    • Ebbers, H.C.1    Mantel-Teeuwisse, A.K.2    Moors, E.H.3
  • 21
    • 85015238186 scopus 로고    scopus 로고
    • Dipartimento di Epidemiologia della Regione Lazio. Roma, 2015.
    • Dipartimento di Epidemiologia della Regione Lazio. Lo stato di salute della popolazione del Lazio 2010-2012. Roma, 2015. http://95.110.213.190/statosal-10-12/note-metod-pat.php?menu=s52
    • (2010) Lo stato di Salute Della Popolazione Del Lazio
  • 22
    • 84879547249 scopus 로고    scopus 로고
    • Genetic matching for estimating causal effects: A general multivariate matching method for achieving balance in observational studies
    • Diamond A, Jasjeet SS. Genetic matching for estimating causal effects: A general multivariate matching method for achieving balance in observational studies. Rev Econ Stat 2013;95: 932-45.
    • (2013) Rev Econ Stat , vol.95 , pp. 932-945
    • Diamond, A.1    Jasjeet, S.S.2
  • 23
    • 77952981609 scopus 로고    scopus 로고
    • Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia
    • Krivoshiev S, Wizemann V, Czekalski S, et al. Therapeutic equivalence of epoetin zeta and alfa, administered subcutaneously, for maintenance treatment of renal anemia. Adv Ther 2010;27: 105-17.
    • (2010) Adv Ther , vol.27 , pp. 105-117
    • Krivoshiev, S.1    Wizemann, V.2    Czekalski, S.3
  • 24
    • 44349139462 scopus 로고    scopus 로고
    • Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia
    • Epoetin Zeta Study Group
    • Krivoshiev S, Todorov VV, Manitius J, et al., Epoetin Zeta Study Group. Comparison of the therapeutic effects of epoetin zeta and epoetin alpha in the correction of renal anaemia. Curr Med Res Opin 2008;24: 1407-15.
    • (2008) Curr Med Res Opin , vol.24 , pp. 1407-1415
    • Krivoshiev, S.1    Todorov, V.V.2    Manitius, J.3
  • 25
    • 36048947690 scopus 로고    scopus 로고
    • Epoetin delta in the management of renal anaemia: Results of a 6-month study
    • Epoetin Delta 3001 Study Group
    • Martin KJ, Epoetin Delta 3001 Study Group. Epoetin delta in the management of renal anaemia: Results of a 6-month study. Nephrol Dial Transplant 2007;22: 3052-4.
    • (2007) Nephrol Dial Transplant , vol.22 , pp. 3052-3054
    • Martin, K.J.1
  • 26
    • 33745188116 scopus 로고    scopus 로고
    • Comparison of two epoetin brands in anemic hemodialysis patients: Results of two efficacy trials and a single-dose pharmacokinetic study
    • Milutinović S, Plavljanić E, Trkulja V. Comparison of two epoetin brands in anemic hemodialysis patients: Results of two efficacy trials and a single-dose pharmacokinetic study. Fundam Clin Pharmacol 2006;20: 493-502.
    • (2006) Fundam Clin Pharmacol , vol.20 , pp. 493-502
    • Milutinović, S.1    Plavljanić, E.2    Trkulja, V.3
  • 27
    • 33845965338 scopus 로고    scopus 로고
    • Epoetin delta is effective for the management of anaemia associated with chronic kidney disease
    • 2002 Study Group
    • Spinowitz BS, Pratt RD, Epoetin Delta 2002 Study Group. Epoetin delta is effective for the management of anaemia associated with chronic kidney disease. Curr Med Res Opin 2006;22: 2507-13.
    • (2006) Curr Med Res Opin , vol.22 , pp. 2507-2513
    • Spinowitz, B.S.1    Pratt, R.D.2    Delta, E.3
  • 28
    • 34548426486 scopus 로고    scopus 로고
    • Randomized trial on the therapeutic equivalence between Eprex and GerEPO in patients on haemodialysis
    • Biogeneric EPO Study Group
    • Goh BL, Ong LM, Sivanandam S, et al., Biogeneric EPO Study Group. Randomized trial on the therapeutic equivalence between Eprex and GerEPO in patients on haemodialysis. Nephrology (Carlton) 2007;12: 431-6.
    • (2007) Nephrology (Carlton) , vol.12 , pp. 431-436
    • Goh, B.L.1    Ong, L.M.2    Sivanandam, S.3
  • 29
    • 70350776252 scopus 로고    scopus 로고
    • Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis
    • NJ-Study Group
    • Haag-Weber M, Vetter A, Thyroff-Friesinger U, et al. NJ-Study Group. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis. Clin Nephrol 2009;72: 380-90.
    • (2009) Clin Nephrol , vol.72 , pp. 380-390
    • Haag-Weber, M.1    Vetter, A.2    Thyroff-Friesinger, U.3
  • 30
    • 84855436897 scopus 로고    scopus 로고
    • Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-A (HX575) in non-dialysis patients with renal anemia: A multi-center, randomized, double-blind study
    • Haag-Weber M, Eckardt KU, Hfrl WH, et al. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-A (HX575) in non-dialysis patients with renal anemia: A multi-center, randomized, double-blind study. Clin Nephrol 2012;77: 8-17.
    • (2012) Clin Nephrol , vol.77 , pp. 8-17
    • Haag-Weber, M.1    Eckardt, K.U.2    Hörl, W.H.3
  • 31
    • 65449117261 scopus 로고    scopus 로고
    • Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: A meta-analysis of randomised trials
    • Bohlius J, Schmidlin K, Brillant C, et al. Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: A meta-analysis of randomised trials. Lancet 2009;373: 1532-42.
    • (2009) Lancet , vol.373 , pp. 1532-1542
    • Bohlius, J.1    Schmidlin, K.2    Brillant, C.3
  • 32
    • 84876736657 scopus 로고    scopus 로고
    • A population-based study comparing biosimilar versus originator erythropoiesisstimulating agent consumption in 6,117 patients with renal anaemia
    • Hörbrand F, Bramlage P, Fischaleck J, et al. A population-based study comparing biosimilar versus originator erythropoiesisstimulating agent consumption in 6,117 patients with renal anaemia. Eur J Clin Pharmacol 2013;69: 929-36.
    • (2013) Eur J Clin Pharmacol , vol.69 , pp. 929-9836
    • Hörbrand, F.1    Bramlage, P.2    Fischaleck, J.3
  • 33
    • 84911401436 scopus 로고    scopus 로고
    • Biosimilars: The science of extrapolation
    • Weise M, Kurki P, Wolff-Holz E, et al. Biosimilars: The science of extrapolation. Blood 2014;124: 3191-6.
    • (2014) Blood , vol.124 , pp. 3191-3196
    • Weise, M.1    Kurki, P.2    Wolff-Holz, E.3
  • 34
    • 79953861167 scopus 로고    scopus 로고
    • Acceptable changes in quality attributes of glycosylated biopharmaceuticals
    • Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29: 310-12.
    • (2011) Nat Biotechnol , vol.29 , pp. 310-312
    • Schiestl, M.1    Stangler, T.2    Torella, C.3
  • 35
    • 84873679430 scopus 로고    scopus 로고
    • Biosimilars in rheumatology: The wind of change
    • Schneider CK. Biosimilars in rheumatology: The wind of change. Ann Rheum Dis 2013;72: 315-18.
    • (2013) Ann Rheum Dis , vol.72 , pp. 315-318
    • Schneider, C.K.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.